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:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00522587
First received: August 27, 2007
Last updated: January 29, 2013
Last verified: January 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00522587     History of Changes
Other Study ID Numbers: 2007/242
Study First Received: August 27, 2007
Last Updated: January 29, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

ClinicalTrials.gov processed this record on April 16, 2014