- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01436799
Desflurane Versus Propofol in the Sitting Position
August 25, 2013 updated by: Hyun Jeong Kwak, Gachon University Gil Medical Center
International Review Board of Gachon University Gil Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
anaesthesia was maintained by desflurane 4-7vol%
Other Names:
administration of alfentanil 10 μg kg-1 for anesthetic induction
Other Names:
administration of rocuronium 0.6 mg kg-1 for anesthetic induction
Other Names:
|
Active Comparator: 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
|
administration of alfentanil 10 μg kg-1 for anesthetic induction
Other Names:
administration of rocuronium 0.6 mg kg-1 for anesthetic induction
Other Names:
anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1 mainly.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Regional Cerebral Oxygen Satuation (rSO2)
Time Frame: 1, 3, 5, 7, and 9 min after the beach chair position
|
definitive values of regional cerebral oxygen saturation(rSO2,%) values are described as mean (SD)
|
1, 3, 5, 7, and 9 min after the beach chair position
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Hyun Jeong Kwak, MD.PhD, Gachon University Gil Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
September 15, 2011
First Submitted That Met QC Criteria
September 19, 2011
First Posted (Estimate)
September 20, 2011
Study Record Updates
Last Update Posted (Estimate)
September 9, 2013
Last Update Submitted That Met QC Criteria
August 25, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Infarction
- Stroke
- Brain Infarction
- Brain Ischemia
- Ischemia
- Cerebral Infarction
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Hypnotics and Sedatives
- Anesthetics, Inhalation
- Neuromuscular Agents
- Neuromuscular Nondepolarizing Agents
- Neuromuscular Blocking Agents
- Propofol
- Desflurane
- Rocuronium
- Alfentanil
Other Study ID Numbers
- GIRBA2466
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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