Back to resultsDesflurane Versus Propofol in the Sitting Position
Primary Purpose
Cerebral Ischemia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
propofol
Desflurane
alfentanil
Rocuronium
Sponsored by
About this trial
This is an interventional prevention trial for Cerebral Ischemia focused on measuring propofol, desflurane, cerebrovascular circulation, sitting
Eligibility Criteria
Inclusion Criteria:
- Forty patients,
- ASA class I or II,
- undergoing shoulder arthroscopy
Exclusion Criteria:
- Patients with history of cerebrovascular disease, coronary occlusive disease and/or obesity (body mass index > 30) were excluded from this study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Desflurane
propofol
Arm Description
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
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
Outcomes
Primary Outcome Measures
Regional Cerebral Oxygen Satuation (rSO2)
definitive values of regional cerebral oxygen saturation(rSO2,%) values are described as mean (SD)
Secondary Outcome Measures
Full Information
NCT ID
NCT01436799
First Posted
September 15, 2011
Last Updated
August 25, 2013
Sponsor
Gachon University Gil Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01436799
Brief Title
Desflurane Versus Propofol in the Sitting Position
Official Title
International Review Board of Gachon University Gil Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators hypothesized that both propofol and desflurane would decrease the regional oxygen saturation (rSO2) but propofol is likely to reduce rSO2 more than sevoflurane when patients are raised to the sitting position.
Detailed Description
The investigators hypothesized that both propofol and desflurane would decrease the rSO2 but propofol is likely to reduce rSO2 more than sevoflurane when patients are raised to the sitting position. Therefore, the purpose of this study was to investigate the effect of desflurane and propofol on rSO2 values during the beach chair position for shoulder arthroscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Ischemia
Keywords
propofol, desflurane, cerebrovascular circulation, sitting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Desflurane
Arm Type
Experimental
Arm Description
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
Arm Title
propofol
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
propofol
Intervention Description
anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1 mainly.
Intervention Type
Drug
Intervention Name(s)
Desflurane
Other Intervention Name(s)
Des
Intervention Description
anaesthesia was maintained by desflurane 4-7vol%
Intervention Type
Drug
Intervention Name(s)
alfentanil
Other Intervention Name(s)
alf
Intervention Description
administration of alfentanil 10 μg kg-1 for anesthetic induction
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Other Intervention Name(s)
roc
Intervention Description
administration of rocuronium 0.6 mg kg-1 for anesthetic induction
Primary Outcome Measure Information:
Title
Regional Cerebral Oxygen Satuation (rSO2)
Description
definitive values of regional cerebral oxygen saturation(rSO2,%) values are described as mean (SD)
Time Frame
1, 3, 5, 7, and 9 min after the beach chair position
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Forty patients,
ASA class I or II,
undergoing shoulder arthroscopy
Exclusion Criteria:
Patients with history of cerebrovascular disease, coronary occlusive disease and/or obesity (body mass index > 30) were excluded from this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Jeong Kwak, MD.PhD
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Desflurane Versus Propofol in the Sitting Position
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