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-ICU1) (NCT NCT05312385)
NCT ID: NCT05312385
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
277 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 participants 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 participants that received at least one dose of study drug. In total 42 run-ins (37 with at least one dose of study drug), 142 randomized isoflurane participants (140 with at least one dose of study drug) and 93 randomized propofol participants (89 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
|
42
|
142
|
93
|
|
Overall Study
COMPLETED
|
37
|
127
|
84
|
|
Overall Study
NOT COMPLETED
|
5
|
15
|
9
|
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-ICU1)
Baseline characteristics by cohort
| Measure |
Isoflurane (Run-ins)
n=42 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 (Randomized)
n=93 Participants
Propofol administered as intravenous infusion All randomized patients
|
Total
n=277 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
|
22 Participants
n=138 Participants
|
81 Participants
n=62 Participants
|
50 Participants
n=123 Participants
|
153 Participants
n=158 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=138 Participants
|
61 Participants
n=62 Participants
|
43 Participants
n=123 Participants
|
124 Participants
n=158 Participants
|
|
Age, Continuous
|
63.5 years
n=138 Participants
|
62.5 years
n=62 Participants
|
64 years
n=123 Participants
|
63 years
n=158 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=138 Participants
|
63 Participants
n=62 Participants
|
39 Participants
n=123 Participants
|
121 Participants
n=158 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=138 Participants
|
79 Participants
n=62 Participants
|
54 Participants
n=123 Participants
|
156 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=138 Participants
|
12 Participants
n=62 Participants
|
10 Participants
n=123 Participants
|
23 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=138 Participants
|
128 Participants
n=62 Participants
|
82 Participants
n=123 Participants
|
249 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=138 Participants
|
2 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
5 Participants
n=158 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=138 Participants
|
1 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=138 Participants
|
4 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
5 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=138 Participants
|
1 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
1 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=138 Participants
|
16 Participants
n=62 Participants
|
7 Participants
n=123 Participants
|
28 Participants
n=158 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=138 Participants
|
116 Participants
n=62 Participants
|
80 Participants
n=123 Participants
|
231 Participants
n=158 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=138 Participants
|
2 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
4 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=138 Participants
|
2 Participants
n=62 Participants
|
3 Participants
n=123 Participants
|
7 Participants
n=158 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=138 Participants
|
142 participants
n=62 Participants
|
93 participants
n=123 Participants
|
277 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=134 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=82 Participants
Propofol administered as intravenous infusion
Propofol: Intravenous infusion of propofol
|
|---|---|---|
|
The 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
|
70 % of time of adequate sedation depth
Standard Deviation 26.26
|
77.7 % of time of adequate sedation depth
Standard Deviation 28.89
|
SECONDARY outcome
Timeframe: From 60 minutes prior to Baseline until end of study treatment (60 minutes + up to 48 (±6) hours)Population: This Outcome Measures 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=140 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=89 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
|
-0.26 µg/kg/hr fentanyl equivalents
Standard Deviation 0.664
|
-0.05 µg/kg/hr fentanyl equivalents
Standard Deviation 0.519
|
SECONDARY outcome
Timeframe: Up to 4 hours after stop of study drug treatment (up to 54 (±6) hours)Population: This Outcome Measures was pre-specified to only assess the Randomized participants (i.e., not Run-in participants)
Outcome measures
| Measure |
Isoflurane
n=77 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=39 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
|
17 minutes
Interval 6.0 to 45.0
|
27 minutes
Interval 10.0 to 95.0
|
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=35 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=31 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)
|
19 Participants
|
10 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
|
9 Participants
|
|
Key Secondary: The Effect of Isoflurane vs Propofol on Cognitive Recovery After End of Study Drug Treatment
Severe Delirium (CAM-ICU7 6-7)
|
7 Participants
|
12 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=134 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=84 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
|
58.9 % of spontaneous breathing efforts
Standard Deviation 38.2
|
58 % of spontaneous breathing efforts
Standard Deviation 35.86
|
SECONDARY outcome
Timeframe: From end of study treatment sedation 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)
To compare the effect of isoflurane vs propofol on time from sedation termination to extubation in patients for whom study drug is terminated for extubation
Outcome measures
| Measure |
Isoflurane
n=70 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=43 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
|
109.5 minutes
Interval 34.0 to 1133.0
|
160 minutes
Interval 33.0 to 1480.0
|
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
|
21.6 Days
Interval 19.17 to 24.02
|
19.7 Days
Interval 16.96 to 22.48
|
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 the ICU
|
15.4 Days
Interval 12.92 to 17.94
|
13.7 Days
Interval 10.81 to 16.51
|
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=177 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=89 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
|
2.5 Days
Standard Deviation 2.16
|
2.4 Days
Standard Deviation 2.08
|
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=177 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=89 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
|
38 Participants
|
22 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=177 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=89 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
|
53 Participants
|
28 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=177 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=89 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
|
31 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=177 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
|
1 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=177 Participants
Inhaled isoflurane administered via Sedaconda ACD-S
Isoflurane: Inhaled isoflurane administered by Sedaconda ACD-S
|
Propofol
n=89 Participants
Propofol administered as intravenous infusion
Propofol: Intravenous infusion of propofol
|
|---|---|---|
|
Other Secondary: The Use of Restraints in Patients Receiving Isoflurane vs Propofol
|
146 Participants
|
74 Participants
|
Adverse Events
Isoflurane (Run-ins and Randomized)
Serious events: 31 serious events
Other events: 55 other events
Deaths: 58 deaths
Propofol (Randomized)
Serious events: 14 serious events
Other events: 22 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
Isoflurane (Run-ins and Randomized)
n=177 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 (Randomized)
n=89 participants at risk
Propofol administered as intravenous infusion
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
2.2%
2/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Infections and infestations
Septic shock
|
3.4%
6/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia staphylococcal
|
1.1%
2/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Infections and infestations
Fungaemia
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Unintentional medical device removal
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.1%
2/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
3.4%
3/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
2.2%
2/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.1%
2/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Surgical and medical procedures
Therapy cessation
|
1.1%
2/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Surgical and medical procedures
Hospice care
|
0.56%
1/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
0.00%
0/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
2.3%
4/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
2.2%
2/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Vascular disorders
Shock
|
1.1%
2/177 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
Other adverse events
| Measure |
Isoflurane (Run-ins and Randomized)
n=177 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 (Randomized)
n=89 participants at risk
Propofol administered as intravenous infusion
|
|---|---|---|
|
Vascular disorders
Hypotension
|
14.7%
26/177 • Number of events 26 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
9.0%
8/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
10/177 • Number of events 11 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
9.0%
8/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Hepatobiliary disorders
Liver injury
|
5.6%
10/177 • Number of events 10 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
5.6%
5/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.1%
9/177 • Number of events 10 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 randomized propofol participants received at least one dose of study drug.
|
1.1%
1/89 • 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). 37 run-ins, 140 randomized isoflurane participants (in total 177) and 89 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