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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
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00522587
Enrollment
40
Registered
2007-08-29
Start date
2008-04-30
Completion date
2011-12-31
Last updated
2013-01-30

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

Conditions

Anesthesia

Brief summary

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

Interventions

DRUGFixed sevoflurane dose 1

Dose 1 of sevoflurane

DRUGFixed sevoflurane dose 2

Dose 2 of sevoflurane

DRUGFixed sevoflurane dose 3

Dose 3 of sevoflurane

DRUGFixed sevoflurane dose 4

Dose 4 of sevoflurane

DRUGFixed sevoflurane dose 5

Dose 5 of sevoflurane

DRUGFixed sevoflurane dose 6

Dose 6 of sevoflurane

DRUGFixed remifentanil dose 1

Dose 1 of remifentanil

DRUGFixed remifentanil dose 2

Dose 2 of remifentanil

DRUGFixed remifentanil dose 3

Dose 3 of remifentanil

DRUGFixed remifentanil dose 4

Dose 4 of remifentanil

DRUGFixed remifentanil dose 5

Dose 5 of remifentanil

DRUGFixed remifentanil dose 6

Dose 6 of remifentanil

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
EEG depression and arousal reactions in response to different clinically relevant stimuli60 to 90 minutes

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026