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

Phase 2

Completed

• Conditions: Anesthesia
• Interventions: 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 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 sevoflurane dose 6; Drug: Fixed remifentanil dose 6

• Registration Number: NCT00522587
• Lead Sponsor: University Hospital, Ghent

Brief Summary

During this study, the pharmacodynamic interactions between sevoflurane and remifentanil will be studied.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-27
• Study First Submitted QC: 2007-08-27
• Study First Posted: 2007-08-29
• Study Start: 2008-04
• Primary Completion: 2009-07
• Study Completion: 2011-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-29
• Last Update Posted: 2013-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Fixed sevoflurane dose 1	Fixed sevoflurane dose 1
2	Fixed sevoflurane dose 2	Fixed sevoflurane dose 2
3	Fixed sevoflurane dose 3	Fixed sevoflurane dose 3
4	Fixed sevoflurane dose 4	Fixed sevoflurane dose 4
5	Fixed sevoflurane dose 5	Fixed sevoflurane dose 5
7	Fixed remifentanil dose 1	Fixed remifentanil dose 1
8	Fixed remifentanil dose 2	Fixed remifentanil dose 2
9	Fixed remifentanil dose 3	Fixed remifentanil dose 3
10	Fixed remifentanil dose 4	Fixed remifentanil dose 4
11	Fixed remifentanil dose 5	Fixed remifentanil dose 5
6	Fixed sevoflurane dose 6	Fixed sevoflurane dose 6
12	Fixed remifentanil dose 6	Fixed remifentanil dose 6

Primary Outcome Measures

Name	Time	Method
EEG depression and arousal reactions in response to different clinically relevant stimuli	60 to 90 minutes

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium