Trial Outcomes & Findings for Recovery Profile Comparison Between Remifentanil-propofol or Desflurane Anesthesia Monitored With Bispectral Index. (NCT NCT02631525)
NCT ID: NCT02631525
Last Updated: 2020-08-25
Results Overview
Time from anesthetic discontinuation to endotracheal tube cuff deflation
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
Time from anesthetic discontinuation to endotracheal tube cuff deflation
Results posted on
2020-08-25
Participant Flow
Participant milestones
| Measure |
REM-PRO
Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models.
Propofol: Total intravenous anesthesia based on propofol
|
REM-DES
Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane.
Desflurane: Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Recovery Profile Comparison Between Remifentanil-propofol or Desflurane Anesthesia Monitored With Bispectral Index.
Baseline characteristics by cohort
| Measure |
REM-PRO
n=20 Participants
Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models.
Propofol: Total intravenous anesthesia based on propofol
|
REM-DES
n=20 Participants
Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane.
Desflurane: Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 15 • n=93 Participants
|
46 years
STANDARD_DEVIATION 11 • n=4 Participants
|
50 years
STANDARD_DEVIATION 14 • n=27 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Brazil
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Time from anesthetic discontinuation to endotracheal tube cuff deflationTime from anesthetic discontinuation to endotracheal tube cuff deflation
Outcome measures
| Measure |
REM-PRO
n=19 Participants
Total intravenous anesthesia with remifentanil and propofol, target controlled infusion based on Minto's and Marsh's pharmacokinetic models.
Propofol: Total intravenous anesthesia based on propofol
|
REM-DES
n=20 Participants
Balanced anesthesia with remifentanil target controlled infusion based on Minto's pharmacokinetic model and desflurane.
Desflurane: Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring
|
|---|---|---|
|
Extubation Time
|
9.5 minutes
Interval 4.9 to 14.4
|
6.2 minutes
Interval 3.1 to 18.5
|
Adverse Events
REM-PRO
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
REM-DES
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place