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

Phase 1

Conditions: American Society of Anesthesia class I and II patients scheduled for surgery under general anesthesia.
MedDRA version: 12.0Level: LLTClassification code 10002323Term: Anesthesia general

Registration Number: EUCTR2009-016094-16-BE

Lead Sponsor: niversity Hospital Ghent

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

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 nitrous oxide, sevoflurane and remifentanil. ;Secondary Objective: ;Primary end point(s): EEG depression and arousal reactions in response to different clinically relevant stimuli.

Secondary Outcome Measures