Sevoflurane-Remifentanil interaction: Multiple response surfaces, validation of calibration stimuli, validation of the intraoperative isobole concept and investigating remifentanil induced opioid tolerance

• Conditions: American Society of Anesthesia class I and II patients scheduled for surgery under general anesthesia

• Registration Number: EUCTR2007-003151-36-BE
• Lead Sponsor: niversity Hospital Ghent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-13
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

American Society of Anesthesia class I and II patients, aged 18-60 years, scheduled for surgery under general anesthesia
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 AMI, any valvular and/or muscular disease involving decrease of the ejection fraction, arrhythmias, which are either symptomatic or require continuous medication/pacemaker/AICD), pulmonary disease including asthma, severe COPD…., Gastric diseases including reflux, endocrinological diseases, and recent use of psycho-active medication, including alcohol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the pharmacodynamic interaction between sevoflurane and remifentanil. The pharmacodynamic clinical effects that will be studied are EEG depression and arousal reactions in response to different clinically relevant stimuli. ;Secondary Objective: ;Primary end point(s): EEG depression and arousal reactions in response to different clinically relevant stimuli.