Trial Outcomes & Findings for Awakening in Spine Surgery: A Comparison Between Clinical Signs and Bispectral Index (NCT NCT02174913)
NCT ID: NCT02174913
Last Updated: 2020-07-13
Results Overview
Awakening time from finished operation to endotracheal extubation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
4 hr
Results posted on
2020-07-13
Participant Flow
Participant milestones
| Measure |
Bispectral Index
Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation.
|
Clinical Signs
Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Awakening in Spine Surgery: A Comparison Between Clinical Signs and Bispectral Index
Baseline characteristics by cohort
| Measure |
Bispectral Index
n=17 Participants
Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation.
|
Clinical Signs
n=17 Participants
Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
48.0 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
49.05 years
STANDARD_DEVIATION 11.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Body weight
|
62.8 kg
STANDARD_DEVIATION 11.8 • n=5 Participants
|
60.4 kg
STANDARD_DEVIATION 8.1 • n=7 Participants
|
61.6 kg
STANDARD_DEVIATION 9.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 hrAwakening time from finished operation to endotracheal extubation.
Outcome measures
| Measure |
Bispectral Index
n=17 Participants
Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation.
|
Clinical Signs
n=17 Participants
Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol.
|
|---|---|---|
|
Extubation Time
|
16.3 min
Standard Deviation 9.7
|
16.6 min
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: From start anesthesia to finish operationtotal propofol dosage = propofol dose from start to end of the operation
Outcome measures
| Measure |
Bispectral Index
n=17 Participants
Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation.
|
Clinical Signs
n=17 Participants
Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol.
|
|---|---|---|
|
Total Propofol Dosage
|
2,146 mg
Standard Deviation 742
|
2,340 mg
Standard Deviation 839
|
Adverse Events
Bispectral Index
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinical Signs
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
Department of Anesthesiology, Siriraj Hospital
Mahidol University
Phone: 66-2-41979889
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place