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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-003151-36-BE
Enrollment
40
Registered
2007-07-13
Start date
2007-08-01
Completion date
Unknown
Last updated
2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Sponsors

University Hospital Ghent
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026