Trial Outcomes & Findings for Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU2) (NCT NCT05327296)
NCT ID: NCT05327296
Last Updated: 2026-03-24
Results Overview
The Target Range is RASS -1 to -4. The Richmond Agitation-Sedation Scale (RASS) is used to measure the level of agitation or sedation in patients, particularly in critical care settings. It is a 10-point scale ranging from -5 to +4: +4 Combative - Violent, immediate danger to staff. +3 Very agitated - Pulls or removes tubes or catheters; aggressive. +2 Agitated - Frequent non-purposeful movement, fights ventilator. +1 Restless - Anxious but movements are not aggressive. 0 Alert and calm. -1 Drowsy - Not fully alert, but has sustained awakening (eye-opening/eye contact) to voice for more than 10 seconds. -2 Light sedation - Briefly awakens with eye contact to voice for less than 10 seconds. -3 Moderate sedation - Movement or eye opening to voice, but no eye contact. -4 Deep sedation - No response to voice, but movement or eye opening to physical stimulation. -5 Unarousable - No response to voice or physical stimulation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
282 participants
Primary outcome timeframe
From start to end of study treatment (up to 48 (±6) hours)
Results posted on
2026-03-24
Participant Flow
3-5 run-in patients treated with isoflurane were enrolled at each site prior to randomization. Run-ins are not analyzed separately, only included in the safety population together with the randomized patients that received at least one dose of study drug. In total 47 run-ins (46 with at least one dose of study drug), 142 randomized isoflurane participants (127 with at least one dose of study drug) and 93 randomized propofol participants (87 with at least one dose of study drug).
Participant milestones
| Measure |
Isoflurane (Run-ins)
Inhaled isoflurane administered via Sedaconda ACD-S
3-5 run-in patients treated with isoflurane were enrolled at each site prior to randomization.
The run-ins are only assessed for safety, together with the portion of patients randomized to isoflurane and receiving at least one dose of study drug
|
Isoflurane
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
Propofol administered as intravenous infusion
Propofol: Intravenous infusion of propofol
|
|---|---|---|---|
|
Overall Study
STARTED
|
47
|
142
|
93
|
|
Overall Study
COMPLETED
|
46
|
112
|
78
|
|
Overall Study
NOT COMPLETED
|
1
|
30
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU2)
Baseline characteristics by cohort
| Measure |
Isoflurane (Run-ins)
n=47 Participants
Inhaled isoflurane administered via Sedaconda ACD-S.
Approximately 3-5 run-in patients were treated at each site for training purposes.
|
Isoflurane (Randomized)
n=142 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
All randomized patients
|
Propofol
n=93 Participants
Propofol administered as intravenous infusion
All randomized patients
|
Total
n=282 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=138 Participants
|
67 Participants
n=62 Participants
|
47 Participants
n=123 Participants
|
138 Participants
n=158 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=138 Participants
|
75 Participants
n=62 Participants
|
46 Participants
n=123 Participants
|
144 Participants
n=158 Participants
|
|
Age, Continuous
|
66 years
n=138 Participants
|
65.5 years
n=62 Participants
|
64 years
n=123 Participants
|
65 years
n=158 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=138 Participants
|
63 Participants
n=62 Participants
|
33 Participants
n=123 Participants
|
105 Participants
n=158 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=138 Participants
|
79 Participants
n=62 Participants
|
60 Participants
n=123 Participants
|
177 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=138 Participants
|
21 Participants
n=62 Participants
|
11 Participants
n=123 Participants
|
41 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=138 Participants
|
108 Participants
n=62 Participants
|
74 Participants
n=123 Participants
|
216 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=138 Participants
|
13 Participants
n=62 Participants
|
8 Participants
n=123 Participants
|
25 Participants
n=158 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=138 Participants
|
6 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
7 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=138 Participants
|
21 Participants
n=62 Participants
|
9 Participants
n=123 Participants
|
34 Participants
n=158 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=138 Participants
|
89 Participants
n=62 Participants
|
73 Participants
n=123 Participants
|
193 Participants
n=158 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=138 Participants
|
26 Participants
n=62 Participants
|
11 Participants
n=123 Participants
|
47 Participants
n=158 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=138 Participants
|
142 participants
n=62 Participants
|
93 participants
n=123 Participants
|
282 participants
n=158 Participants
|
PRIMARY outcome
Timeframe: From start to end of study treatment (up to 48 (±6) hours)Population: This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants)
The Target Range is RASS -1 to -4. The Richmond Agitation-Sedation Scale (RASS) is used to measure the level of agitation or sedation in patients, particularly in critical care settings. It is a 10-point scale ranging from -5 to +4: +4 Combative - Violent, immediate danger to staff. +3 Very agitated - Pulls or removes tubes or catheters; aggressive. +2 Agitated - Frequent non-purposeful movement, fights ventilator. +1 Restless - Anxious but movements are not aggressive. 0 Alert and calm. -1 Drowsy - Not fully alert, but has sustained awakening (eye-opening/eye contact) to voice for more than 10 seconds. -2 Light sedation - Briefly awakens with eye contact to voice for less than 10 seconds. -3 Moderate sedation - Movement or eye opening to voice, but no eye contact. -4 Deep sedation - No response to voice, but movement or eye opening to physical stimulation. -5 Unarousable - No response to voice or physical stimulation.
Outcome measures
| Measure |
Isoflurane
n=123 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=81 Participants
Propofol administered as intravenous infusion
Propofol: Intravenous infusion of propofol
|
|---|---|---|
|
Percentage of Time Sedation Depth is Maintained Within the Target Range, in Absence of Rescue Sedation, as Assessed According to the RASS Scale, in Isoflurane- vs Propofol-treated Patients
|
72 percentage of time
Standard Deviation 26.6
|
73.7 percentage of time
Standard Deviation 29.15
|
SECONDARY outcome
Timeframe: From 60 minutes prior to Baseline until end of study treatment (60 minutes + up to 48 (±6) hours)Population: This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants)
To compare the effect of isoflurane vs propofol on use of opioids during the study treatment period by measuring change in mean fentanyl-equivalent opioid dose during the study treatment period compared to mean opioid dose during the 60 minutes prior to baseline.
Outcome measures
| Measure |
Isoflurane
n=127 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=87 Participants
Propofol administered as intravenous infusion
Propofol: Intravenous infusion of propofol
|
|---|---|---|
|
Key Secondary: The Effect of Isoflurane vs Propofol on Use of Opioids During the Study Treatment Period
|
-0.29 µg/kg/hr fentanyl equivalents
Standard Deviation 0.91
|
0.03 µg/kg/hr fentanyl equivalents
Standard Deviation 0.601
|
SECONDARY outcome
Timeframe: Up to 4 hours after stop of study drug treatment (up to 54 (±6) hours)Population: This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants)
Outcome measures
| Measure |
Isoflurane
n=87 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=45 Participants
Propofol administered as intravenous infusion
Propofol: Intravenous infusion of propofol
|
|---|---|---|
|
Key Secondary: The Effect of Isoflurane vs Propofol on the Wake up Time at End of Study Drug Treatment
|
13.0 minutes
Interval 5.0 to 50.0
|
17.0 minutes
Interval 7.0 to 30.0
|
SECONDARY outcome
Timeframe: At 60 minutes (±10 minutes) after end of study drug treatment (up to 49 (±6) hours)Population: This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants)
Cognitive recovery will be assessed by the 7-point scale of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU-7) at 60 (±10) minutes after end of study drug treatment in patients not re-sedated with benzodiazepine or propofol infusions. The scale ranges from 0 to 7, with higher scores indicating more severe delirium
Outcome measures
| Measure |
Isoflurane
n=41 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=32 Participants
Propofol administered as intravenous infusion
Propofol: Intravenous infusion of propofol
|
|---|---|---|
|
Key Secondary: The Effect of Isoflurane vs Propofol on Cognitive Recovery After End of Study Drug Treatment
No Delirium (CAM-ICU7 0-2)
|
20 Participants
|
23 Participants
|
|
Key Secondary: The Effect of Isoflurane vs Propofol on Cognitive Recovery After End of Study Drug Treatment
Mild/Moderate Delirium (CAM-ICU7 3-5)
|
9 Participants
|
5 Participants
|
|
Key Secondary: The Effect of Isoflurane vs Propofol on Cognitive Recovery After End of Study Drug Treatment
Severe Delirium (CAM-ICU7 6-7)
|
12 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From start to end of study treatment, up to 48 (±6) hoursPopulation: This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants)
Proportion of ventilator parameter observations with spontaneous breathing efforts during the study drug treatment period
Outcome measures
| Measure |
Isoflurane
n=118 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=80 Participants
Propofol administered as intravenous infusion
Propofol: Intravenous infusion of propofol
|
|---|---|---|
|
Key Secondary: The Effect of Isoflurane vs Propofol on Spontaneous Breathing Effort During the Study Drug Treatment Period
|
69.9 % of observations
Standard Deviation 38.28
|
54.6 % of observations
Standard Deviation 39.25
|
SECONDARY outcome
Timeframe: From end of study drug treatment to extubation (up to 7 Days after randomization)Population: This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants)
Outcome measures
| Measure |
Isoflurane
n=64 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=42 Participants
Propofol administered as intravenous infusion
Propofol: Intravenous infusion of propofol
|
|---|---|---|
|
Other Secondary: The Effect of Isoflurane vs Propofol on Time From Sedation Termination to Extubation in Patients for Whom Study Drug is Terminated for Extubation
|
67.5 Time to extubation (minutes)
Interval 17.5 to 1538.5
|
80.0 Time to extubation (minutes)
Interval 14.0 to 1200.0
|
SECONDARY outcome
Timeframe: From start of study treatment up to 30 daysPopulation: This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants)
Outcome measures
| Measure |
Isoflurane
n=142 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=93 Participants
Propofol administered as intravenous infusion
Propofol: Intravenous infusion of propofol
|
|---|---|---|
|
Other Secondary: The Effect of Isoflurane vs Propofol on Days Alive and Free of Mechanical Ventilation Through Study Day 30
|
19.6 Days
Interval 17.17 to 22.1
|
19.8 Days
Interval 17.02 to 22.55
|
SECONDARY outcome
Timeframe: From start of study treatment up to 30 daysPopulation: This Outcome Measure was pre-specified to only assess the Randomized participants (i.e., not Run-in participants)
Outcome measures
| Measure |
Isoflurane
n=142 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=93 Participants
Propofol administered as intravenous infusion
Propofol: Intravenous infusion of propofol
|
|---|---|---|
|
Other Secondary: To Compare the Effect of Isoflurane vs Propofol on Days Alive and Free of the ICU
|
12.5 Days
Interval 10.12 to 14.86
|
12.1 Days
Interval 9.4 to 14.67
|
SECONDARY outcome
Timeframe: From start of study treatment until 7 days after end of treatment (up to 9 days post study drug treatment initiation)Population: This Outcome Measure was pre-specified to be assess based on the Safety Population (run-in patients and Randomized participants that received any study drug)
Outcome measures
| Measure |
Isoflurane
n=173 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=87 Participants
Propofol administered as intravenous infusion
Propofol: Intravenous infusion of propofol
|
|---|---|---|
|
Other Secondary: The Effect of Isoflurane vs Propofol on Delirium and Coma Free Days Until 7 Days After End of Study Treatment
|
1.9 Days
Standard Deviation 1.86
|
2.6 Days
Standard Deviation 2.15
|
SECONDARY outcome
Timeframe: At 30 days after randomizationParticipants reported represent participants that died between randomization and 30 days in the Safety population
Outcome measures
| Measure |
Isoflurane
n=173 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=87 Participants
Propofol administered as intravenous infusion
Propofol: Intravenous infusion of propofol
|
|---|---|---|
|
Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 30 Days After Randomization
|
39 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: At 3 months after randomizationParticipants reported represent participants that died between randomization and 3 months in the Safety population
Outcome measures
| Measure |
Isoflurane
n=173 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=87 Participants
Propofol administered as intravenous infusion
Propofol: Intravenous infusion of propofol
|
|---|---|---|
|
Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 3 Months After Randomization
|
52 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: At 6 months after randomizationParticipants reported represent participants that died between randomization and 6 months in the Safety population
Outcome measures
| Measure |
Isoflurane
n=173 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=87 Participants
Propofol administered as intravenous infusion
Propofol: Intravenous infusion of propofol
|
|---|---|---|
|
Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 6 Months After Randomization
|
58 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: From start to end of study treatment (up to 48 (±6) hours)Population: This Outcome Measure was pre-specified to be assess based on the Safety Population (run-in patients and Randomized participants that received any study drug)
Outcome measures
| Measure |
Isoflurane
n=173 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
Propofol administered as intravenous infusion
Propofol: Intravenous infusion of propofol
|
|---|---|---|
|
Other Secondary: Sedaconda ACD-S Device Deficiencies in Patients Receiving Isoflurane
|
7 Device Deficiencies
|
—
|
SECONDARY outcome
Timeframe: From start to end of study treatment (up to 48 (±6) hours)Population: This Outcome Measure was pre-specified to be assess based on the Safety Population (run-in patients and Randomized participants that received any study drug)
Incidence of restraints measured twice daily
Outcome measures
| Measure |
Isoflurane
n=173 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=87 Participants
Propofol administered as intravenous infusion
Propofol: Intravenous infusion of propofol
|
|---|---|---|
|
Other Secondary: The Use of Restraints in Patients Receiving Isoflurane vs Propofol
|
138 Participants
|
73 Participants
|
Adverse Events
Isoflurane (Run-ins and Randomized)
Serious events: 33 serious events
Other events: 92 other events
Deaths: 58 deaths
Propofol
Serious events: 24 serious events
Other events: 52 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
Isoflurane (Run-ins and Randomized)
n=173 participants at risk
Inhaled isoflurane administered via Sedaconda ACD-S
3-5 run-in patients treated with isoflurane were enrolled at each site prior to randomization
|
Propofol
n=87 participants at risk
Propofol administered as intravenous infusion
Propofol: Intravenous infusion of propofol
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 2 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Cardiac disorders
Bradycardia
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Cardiac disorders
Atrial tachycardia
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
2.3%
2/87 • Number of events 2 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.7%
3/173 • Number of events 3 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
General disorders
Disease progression
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
2.3%
2/87 • Number of events 2 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Infections and infestations
Postoperative wound infection
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Infections and infestations
Infection
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Infections and infestations
Candida infection
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Infections and infestations
Empyema
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Infections and infestations
Corynebacterium bacteraemia
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
1.2%
2/173 • Number of events 2 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Tracheal injury
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Postoperative thrombosis
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Mechanical ventilation complication
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
1.2%
2/173 • Number of events 2 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Nervous system disorders
Seizure
|
1.2%
2/173 • Number of events 2 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Nervous system disorders
Depressed level of consciousnessv
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
2/173 • Number of events 2 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
2.3%
2/87 • Number of events 2 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.5%
6/173 • Number of events 6 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
4.6%
4/87 • Number of events 4 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.3%
4/173 • Number of events 4 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
2.3%
2/87 • Number of events 2 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bradypnoea
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
1.2%
2/173 • Number of events 2 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
6.9%
6/87 • Number of events 8 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Vascular disorders
Shock
|
1.2%
2/173 • Number of events 2 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Vascular disorders
Peripheral ischaemia
|
0.58%
1/173 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/87 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Vascular disorders
Lymphatic fistula
|
0.00%
0/173 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/87 • Number of events 1 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
Other adverse events
| Measure |
Isoflurane (Run-ins and Randomized)
n=173 participants at risk
Inhaled isoflurane administered via Sedaconda ACD-S
3-5 run-in patients treated with isoflurane were enrolled at each site prior to randomization
|
Propofol
n=87 participants at risk
Propofol administered as intravenous infusion
Propofol: Intravenous infusion of propofol
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.2%
9/173 • Number of events 9 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
5.7%
5/87 • Number of events 5 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.2%
9/173 • Number of events 9 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
5.7%
5/87 • Number of events 5 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.0%
7/173 • Number of events 7 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
5.7%
5/87 • Number of events 5 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Hepatobiliary disorders
Liver injury
|
2.9%
5/173 • Number of events 5 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
6.9%
6/87 • Number of events 6 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
2.9%
5/173 • Number of events 5 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
5.7%
5/87 • Number of events 5 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Investigations
Amylase increased
|
1.7%
3/173 • Number of events 3 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
5.7%
5/87 • Number of events 5 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.0%
7/173 • Number of events 7 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
8.0%
7/87 • Number of events 7 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
4.0%
7/173 • Number of events 7 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
8.0%
7/87 • Number of events 7 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.9%
5/173 • Number of events 5 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
9.2%
8/87 • Number of events 8 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.3%
4/173 • Number of events 4 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
8.0%
7/87 • Number of events 7 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
2.3%
4/173 • Number of events 4 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
6.9%
6/87 • Number of events 6 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.0%
7/173 • Number of events 7 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
5.7%
5/87 • Number of events 5 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.4%
18/173 • Number of events 21 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
8.0%
7/87 • Number of events 7 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
22.5%
39/173 • Number of events 51 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
21.8%
19/87 • Number of events 21 • Adverse Events were collected from initiation of study drug administration until Day 7 post End Of Treatment (up to 9 days post treatment initiation). All-Cause Mortality was assessed for up to 6 months post randomization.
AEs were defined in relation to the patient's condition. Patients were monitored for clinical and laboratory evidence for pre-defined AESIs. AEs and overall mortality as presented here represent the Safety population (i.e. for all patients receiving any amount of study drug, including both run-ins and randomized patients). 46 run-ins, 127 randomized isoflurane participants (in total 173) and 87 randomized propofol participants received at least one dose of study drug.
|
Additional Information
Director Clinical Development and Operations
Sedana Medical
Phone: +46 (0)8 124 05 200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place