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Desflurane Versus Propofol in the Sitting Position

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ClinicalTrials.gov Identifier: NCT01436799
Recruitment Status : Completed
First Posted : September 20, 2011
Results First Posted : August 26, 2013
Last Update Posted : September 9, 2013
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Cerebral Ischemia Drug: propofol Drug: Desflurane Drug: alfentanil Drug: Rocuronium

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: International Review Board of Gachon University Gil Hospital
Study Start Date : March 2011
Primary Completion Date : August 2011
Study Completion Date : August 2011

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U.S. FDA Resources

Arms and Interventions

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
Drug: Desflurane
anaesthesia was maintained by desflurane 4-7vol%
Other Name: Des
Drug: alfentanil
administration of alfentanil 10 μg kg-1 for anesthetic induction
Other Name: alf
Drug: Rocuronium
administration of rocuronium 0.6 mg kg-1 for anesthetic induction
Other Name: roc
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
Drug: propofol
anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1 mainly.
Drug: alfentanil
administration of alfentanil 10 μg kg-1 for anesthetic induction
Other Name: alf
Drug: Rocuronium
administration of rocuronium 0.6 mg kg-1 for anesthetic induction
Other Name: roc


Outcome Measures

Primary Outcome Measures :
  1. 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)


Eligibility Criteria

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436799


Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
Study Director: Hyun Jeong Kwak, MD.PhD Gachon University Gil Medical Center
More Information

Responsible Party: Hyun Jeong Kwak, Associate professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01436799     History of Changes
Other Study ID Numbers: GIRBA2466
First Posted: September 20, 2011    Key Record Dates
Results First Posted: August 26, 2013
Last Update Posted: September 9, 2013
Last Verified: August 2013

Keywords provided by Hyun Jeong Kwak, Gachon University Gil Medical Center:
propofol
desflurane
cerebrovascular circulation
sitting

Additional relevant MeSH terms:
Ischemia
Brain Ischemia
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Stroke
Anesthetics
Propofol
Desflurane
Isoflurane
Alfentanil
Rocuronium
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Anesthetics, Inhalation
Analgesics, Opioid
Narcotics