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

January 29, 2013 updated by: University Hospital, Ghent
During this study, the pharmacodynamic interactions between sevoflurane and remifentanil will be studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
EEG depression and arousal reactions in response to different clinically relevant stimuli
Time Frame: 60 to 90 minutes
60 to 90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Michel Struys, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

April 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 27, 2007

First Submitted That Met QC Criteria

August 27, 2007

First Posted (Estimate)

August 29, 2007

Study Record Updates

Last Update Posted (Estimate)

January 30, 2013

Last Update Submitted That Met QC Criteria

January 29, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007/242

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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