Trial Outcomes & Findings for Post Extubation Delirium and End-tidal Sevoflurane Concentration (NCT NCT02489734)
NCT ID: NCT02489734
Last Updated: 2021-08-19
Results Overview
The primary outcome was the number of participants with emergence delirium (ED) according to the peak PAED score measured by Pediatric Anesthesia Emergence Delirium Scale. All PAED (Pediatric Anesthesia Emergence Delirium scale) scores were assessed by a dedicated nurse who was blinded to the random assignment of patients to group. PAED scores were assessed on awakening (defined as reactive to verbal command or opening of eyes or crying in response to slight touch) and then every 5 minutes for 30 minutes. If the PAED score was ≥ 16, propofol 1 mg.kg-1 was administrated. After administration of propofol, PAED scores were no longer assessed. The peak (highest) PAED score for each patient was analyzed. ED was defined as a peak PAED score \>12. Higher score of PAED means a worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
109 participants
Primary outcome timeframe
within 30 minutes after awakening
Results posted on
2021-08-19
Participant Flow
From July 2015 to September 2015, 135 patients were assessed for eligibility in Children's Hospital of Fudan University.
Of 135 patients assessed for eligibility, 26 patients were excluded because they did not meet the inclusion criteria or declined to participate in the study.
Participant milestones
| Measure |
Low Concentration (LC)
low concentration group
sevoflurane: extubation when end-tidal concentration of sevoflurane \< 0.5%.
|
High Concentration (HC)
high concentration group
Sevoflurane: extubation when end-tidal concentration of sevoflurane \>= 0.5%.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
53
|
|
Overall Study
COMPLETED
|
39
|
53
|
|
Overall Study
NOT COMPLETED
|
17
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post Extubation Delirium and End-tidal Sevoflurane Concentration
Baseline characteristics by cohort
| Measure |
Low Concentration (LC)
n=39 Participants
In the LC group, the trachea was extubated as soon as cough or purposeful movement appeared when end-tidal sevoflurane concentration was less than 0.5%. Patients were excluded in this group if cough or purposeful movement appeared when end-tidal sevoflurane concentration was more than 0.5%.
|
High Concentration (HC)
n=53 Participants
In the HC group, when end-tidal sevoflurane concentration was more than 0.5%, the trachea was extubated as soon as cough or purposeful movement appeared. If there was still no cough or purposeful movement when end-tidal sevoflurane concentration had decreased to 0.5%, the trachea was extubated at this concentration.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.4 years
STANDARD_DEVIATION 1.4 • n=99 Participants
|
3.9 years
STANDARD_DEVIATION 1.5 • n=107 Participants
|
3.7 years
STANDARD_DEVIATION 1.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Weight
|
18.2 kg
STANDARD_DEVIATION 4.4 • n=99 Participants
|
19.5 kg
STANDARD_DEVIATION 4.9 • n=107 Participants
|
18.9 kg
STANDARD_DEVIATION 4.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: within 30 minutes after awakeningThe primary outcome was the number of participants with emergence delirium (ED) according to the peak PAED score measured by Pediatric Anesthesia Emergence Delirium Scale. All PAED (Pediatric Anesthesia Emergence Delirium scale) scores were assessed by a dedicated nurse who was blinded to the random assignment of patients to group. PAED scores were assessed on awakening (defined as reactive to verbal command or opening of eyes or crying in response to slight touch) and then every 5 minutes for 30 minutes. If the PAED score was ≥ 16, propofol 1 mg.kg-1 was administrated. After administration of propofol, PAED scores were no longer assessed. The peak (highest) PAED score for each patient was analyzed. ED was defined as a peak PAED score \>12. Higher score of PAED means a worse outcome.
Outcome measures
| Measure |
Low Concentration (LC)
n=39 Participants
In the LC group, the trachea was extubated as soon as cough or purposeful movement appeared when end-tidal sevoflurane concentration was less than 0.5%. Patients were excluded in this group if cough or purposeful movement appeared when end-tidal sevoflurane concentration was more than 0.5%.
|
High Concentration (HC)
n=53 Participants
In the HC group, when end-tidal sevoflurane concentration was more than 0.5%, the trachea was extubated as soon as cough or purposeful movement appeared. If there was still no cough or purposeful movement when end-tidal sevoflurane concentration had decreased to 0.5%, the trachea was extubated at this concentration.
|
|---|---|---|
|
Number of Participants With Emergence Delirium (ED)
|
5 Participants
|
23 Participants
|
Adverse Events
Low Concentration (LC)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
High Concentration (HC)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Concentration (LC)
n=39 participants at risk
In the LC group, the trachea was extubated as soon as cough or purposeful movement appeared when end-tidal sevoflurane concentration was less than 0.5%. Patients were excluded in this group if cough or purposeful movement appeared when end-tidal sevoflurane concentration was more than 0.5%.
|
High Concentration (HC)
n=53 participants at risk
In the HC group, when end-tidal sevoflurane concentration was more than 0.5%, the trachea was extubated as soon as cough or purposeful movement appeared. If there was still no cough or purposeful movement when end-tidal sevoflurane concentration had decreased to 0.5%, the trachea was extubated at this concentration.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
respiratory obstruction
|
0.00%
0/39 • Adverse events were assessed and recorded during the PACU, an average of 1 hour.
In the PACU, any adverse events such as hypoxemia (defined as SpO2 \<92%), laryngospasm (defined as inability to ventilate despite maneuvers to relieve airway obstruction), bronchospasm (defined as wheezing on auscultation), respiratory obstruction (defined as chin lift, oral airway, or reintubation needed to avoid hypoxemia), or postoperative nausea and vomiting (PONV) were recorded by the same nurse.
|
5.7%
3/53 • Adverse events were assessed and recorded during the PACU, an average of 1 hour.
In the PACU, any adverse events such as hypoxemia (defined as SpO2 \<92%), laryngospasm (defined as inability to ventilate despite maneuvers to relieve airway obstruction), bronchospasm (defined as wheezing on auscultation), respiratory obstruction (defined as chin lift, oral airway, or reintubation needed to avoid hypoxemia), or postoperative nausea and vomiting (PONV) were recorded by the same nurse.
|
|
Gastrointestinal disorders
postoperative nausea and vomiting
|
7.7%
3/39 • Adverse events were assessed and recorded during the PACU, an average of 1 hour.
In the PACU, any adverse events such as hypoxemia (defined as SpO2 \<92%), laryngospasm (defined as inability to ventilate despite maneuvers to relieve airway obstruction), bronchospasm (defined as wheezing on auscultation), respiratory obstruction (defined as chin lift, oral airway, or reintubation needed to avoid hypoxemia), or postoperative nausea and vomiting (PONV) were recorded by the same nurse.
|
3.8%
2/53 • Adverse events were assessed and recorded during the PACU, an average of 1 hour.
In the PACU, any adverse events such as hypoxemia (defined as SpO2 \<92%), laryngospasm (defined as inability to ventilate despite maneuvers to relieve airway obstruction), bronchospasm (defined as wheezing on auscultation), respiratory obstruction (defined as chin lift, oral airway, or reintubation needed to avoid hypoxemia), or postoperative nausea and vomiting (PONV) were recorded by the same nurse.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxemia
|
0.00%
0/39 • Adverse events were assessed and recorded during the PACU, an average of 1 hour.
In the PACU, any adverse events such as hypoxemia (defined as SpO2 \<92%), laryngospasm (defined as inability to ventilate despite maneuvers to relieve airway obstruction), bronchospasm (defined as wheezing on auscultation), respiratory obstruction (defined as chin lift, oral airway, or reintubation needed to avoid hypoxemia), or postoperative nausea and vomiting (PONV) were recorded by the same nurse.
|
0.00%
0/53 • Adverse events were assessed and recorded during the PACU, an average of 1 hour.
In the PACU, any adverse events such as hypoxemia (defined as SpO2 \<92%), laryngospasm (defined as inability to ventilate despite maneuvers to relieve airway obstruction), bronchospasm (defined as wheezing on auscultation), respiratory obstruction (defined as chin lift, oral airway, or reintubation needed to avoid hypoxemia), or postoperative nausea and vomiting (PONV) were recorded by the same nurse.
|
|
Respiratory, thoracic and mediastinal disorders
laryngospasm
|
0.00%
0/39 • Adverse events were assessed and recorded during the PACU, an average of 1 hour.
In the PACU, any adverse events such as hypoxemia (defined as SpO2 \<92%), laryngospasm (defined as inability to ventilate despite maneuvers to relieve airway obstruction), bronchospasm (defined as wheezing on auscultation), respiratory obstruction (defined as chin lift, oral airway, or reintubation needed to avoid hypoxemia), or postoperative nausea and vomiting (PONV) were recorded by the same nurse.
|
0.00%
0/53 • Adverse events were assessed and recorded during the PACU, an average of 1 hour.
In the PACU, any adverse events such as hypoxemia (defined as SpO2 \<92%), laryngospasm (defined as inability to ventilate despite maneuvers to relieve airway obstruction), bronchospasm (defined as wheezing on auscultation), respiratory obstruction (defined as chin lift, oral airway, or reintubation needed to avoid hypoxemia), or postoperative nausea and vomiting (PONV) were recorded by the same nurse.
|
|
Respiratory, thoracic and mediastinal disorders
bronchospasm
|
0.00%
0/39 • Adverse events were assessed and recorded during the PACU, an average of 1 hour.
In the PACU, any adverse events such as hypoxemia (defined as SpO2 \<92%), laryngospasm (defined as inability to ventilate despite maneuvers to relieve airway obstruction), bronchospasm (defined as wheezing on auscultation), respiratory obstruction (defined as chin lift, oral airway, or reintubation needed to avoid hypoxemia), or postoperative nausea and vomiting (PONV) were recorded by the same nurse.
|
0.00%
0/53 • Adverse events were assessed and recorded during the PACU, an average of 1 hour.
In the PACU, any adverse events such as hypoxemia (defined as SpO2 \<92%), laryngospasm (defined as inability to ventilate despite maneuvers to relieve airway obstruction), bronchospasm (defined as wheezing on auscultation), respiratory obstruction (defined as chin lift, oral airway, or reintubation needed to avoid hypoxemia), or postoperative nausea and vomiting (PONV) were recorded by the same nurse.
|
Additional Information
Dr. Xuan Wang
Children's Hospital of Fudan University
Phone: 021-18017591058
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place