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Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00522587
First Posted: August 29, 2007
Last Update Posted: January 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Ghent
  Purpose
During this study, the pharmacodynamic interactions between sevoflurane and remifentanil will be studied.

Condition Intervention Phase
Anesthesia Drug: Fixed sevoflurane dose 1 Drug: Fixed sevoflurane dose 2 Drug: Fixed sevoflurane dose 3 Drug: Fixed sevoflurane dose 4 Drug: Fixed sevoflurane dose 5 Drug: Fixed sevoflurane dose 6 Drug: Fixed remifentanil dose 1 Drug: Fixed remifentanil dose 2 Drug: Fixed remifentanil dose 3 Drug: Fixed remifentanil dose 4 Drug: Fixed remifentanil dose 5 Drug: Fixed remifentanil dose 6 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • EEG depression and arousal reactions in response to different clinically relevant stimuli [ Time Frame: 60 to 90 minutes ]

Enrollment: 40
Study Start Date: April 2008
Study Completion Date: December 2011
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fixed sevoflurane dose 1
Drug: Fixed sevoflurane dose 1
Dose 1 of sevoflurane
Experimental: 2
Fixed sevoflurane dose 2
Drug: Fixed sevoflurane dose 2
Dose 2 of sevoflurane
Experimental: 3
Fixed sevoflurane dose 3
Drug: Fixed sevoflurane dose 3
Dose 3 of sevoflurane
Experimental: 4
Fixed sevoflurane dose 4
Drug: Fixed sevoflurane dose 4
Dose 4 of sevoflurane
Experimental: 5
Fixed sevoflurane dose 5
Drug: Fixed sevoflurane dose 5
Dose 5 of sevoflurane
Experimental: 6
Fixed sevoflurane dose 6
Drug: Fixed sevoflurane dose 6
Dose 6 of sevoflurane
Experimental: 7
Fixed remifentanil dose 1
Drug: Fixed remifentanil dose 1
Dose 1 of remifentanil
Experimental: 8
Fixed remifentanil dose 2
Drug: Fixed remifentanil dose 2
Dose 2 of remifentanil
Experimental: 9
Fixed remifentanil dose 3
Drug: Fixed remifentanil dose 3
Dose 3 of remifentanil
Experimental: 10
Fixed remifentanil dose 4
Drug: Fixed remifentanil dose 4
Dose 4 of remifentanil
Experimental: 11
Fixed remifentanil dose 5
Drug: Fixed remifentanil dose 5
Dose 5 of remifentanil
Experimental: 12
Fixed remifentanil dose 6
Drug: Fixed remifentanil dose 6
Dose 6 of remifentanil

  Eligibility

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesia class I and II patients
  • Aged 18-60 years
  • Scheduled for surgery under general anesthesia

Exclusion Criteria:

  • Weight less than 70% or more than 130% of ideal body weight
  • Neurological disorder
  • Diseases involving the cardiovascular system (hypertension, coronary artery disease, prior acute myocardial infarction (AMI), any valvular and/or muscular disease involving decrease of the ejection fraction, arrhythmias, which are either symptomatic or require continuous medication/pacemaker/automatic implantable cardioverter defibrillator [AICD])
  • Pulmonary disease including asthma, severe chronic obstructive pulmonary disease (COPD), etc.
  • Gastric diseases including reflux, endocrinological diseases
  • Recent use of psycho-active medication, including alcohol.
  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): NCT00522587


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Michel Struys, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00522587     History of Changes
Other Study ID Numbers: 2007/242
First Submitted: August 27, 2007
First Posted: August 29, 2007
Last Update Posted: January 30, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Remifentanil
Sevoflurane
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation