Desflurane Versus Propofol in the Sitting Position

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hyun Jeong Kwak, Gachon University Gil Medical Center

ClinicalTrials.gov Identifier:

NCT01436799

First received: September 15, 2011

Last updated: August 25, 2013

Last verified: August 2013

History of Changes

Purpose

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	Intervention
Cerebral Ischemia	Drug: propofol Drug: Desflurane Drug: alfentanil Drug: Rocuronium


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention
Official Title:	International Review Board of Gachon University Gil Hospital

Resource links provided by NLM:

Drug Information available for: Propofol Desflurane Alfentanil hydrochloride Alfentanil Rocuronium bromide Rocuronium

U.S. FDA Resources

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:

Regional Cerebral Oxygen Satuation (rSO2) [ Time Frame: 1, 3, 5, 7, and 9 min after the beach chair position ] [ Designated as safety issue: Yes ]
definitive values of regional cerebral oxygen saturation(rSO2,%) values are described as mean (SD)


Enrollment:	40
Study Start Date:	March 2011
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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.

Eligibility


Ages Eligible for Study:	20 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
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

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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	September 15, 2011
Results First Received:	February 5, 2013
Last Updated:	August 25, 2013
Health Authority:	Korea: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 28, 2016

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