Trial Outcomes & Findings for Desflurane Versus Propofol in the Sitting Position (NCT NCT01436799)
NCT ID: NCT01436799
Last Updated: 2013-09-09
Results Overview
definitive values of regional cerebral oxygen saturation(rSO2,%) values are described as mean (SD)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
1, 3, 5, 7, and 9 min after the beach chair position
Results posted on
2013-09-09
Participant Flow
March 2011-August 2011 in Gachon University Gil Medical Center, who underwent arthroscopic shoulder surgery
no enrolled participants were excluded.
Participant milestones
| Measure |
Desflurane
anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane
|
Propofol
anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model
|
|---|---|---|
|
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
Desflurane Versus Propofol in the Sitting Position
Baseline characteristics by cohort
| Measure |
Desflurane
n=20 Participants
anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane
|
Propofol
n=20 Participants
anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
48 years
STANDARD_DEVIATION 10 • n=5 Participants
|
48 years
STANDARD_DEVIATION 16 • n=7 Participants
|
48 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1, 3, 5, 7, and 9 min after the beach chair positionPopulation: A power analysis was calculated based on a previous study.14 In each group, 16 patients were needed to detect a mean intergroup difference of 5% in the rSO2 value with a power of 80% and a type I error of 0.05. To compensate for a dropout rate of 20%, 40 patients were included in this study.
definitive values of regional cerebral oxygen saturation(rSO2,%) values are described as mean (SD)
Outcome measures
| Measure |
Desflurane
n=20 Participants
anesthetic maintenence with desflurane
|
Propofol
n=20 Participants
anesthetic maintanence with propofol
|
|---|---|---|
|
Regional Cerebral Oxygen Satuation (rSO2)
7min after beach chair position
|
75.1 percentage of rSO2 (%)
Standard Deviation 7.2
|
68.5 percentage of rSO2 (%)
Standard Deviation 10.1
|
|
Regional Cerebral Oxygen Satuation (rSO2)
1min after beach chair position
|
77.4 percentage of rSO2 (%)
Standard Deviation 7
|
72.5 percentage of rSO2 (%)
Standard Deviation 9.5
|
|
Regional Cerebral Oxygen Satuation (rSO2)
3min after beach chair position
|
76 percentage of rSO2 (%)
Standard Deviation 7.1
|
70 percentage of rSO2 (%)
Standard Deviation 9.8
|
|
Regional Cerebral Oxygen Satuation (rSO2)
5min after beach chair position
|
75.2 percentage of rSO2 (%)
Standard Deviation 7.4
|
70 percentage of rSO2 (%)
Standard Deviation 8.5
|
|
Regional Cerebral Oxygen Satuation (rSO2)
9min after beach chair position
|
74 percentage of rSO2 (%)
Standard Deviation 7.8
|
67.8 percentage of rSO2 (%)
Standard Deviation 9.8
|
Adverse Events
Desflurane
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Propofol
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