Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance
Information source: University Hospital, Ghent
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anesthesia
Intervention: 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 sevoflurane dose 6 (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 remifentanil dose 6 (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University Hospital, Ghent Official(s) and/or principal investigator(s):
Michel Struys, MD, PhD, Principal Investigator, Affiliation: University Hospital, Ghent
Summary
During this study, the pharmacodynamic interactions between sevoflurane and remifentanil
will be studied.
Clinical Details
Official title: Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: EEG depression and arousal reactions in response to different clinically relevant stimuli
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
University Hospital Ghent, Ghent 9000, Belgium
Additional Information
Website of the University Hospital Ghent
Starting date: April 2008
Last updated: January 29, 2013
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