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NCT00522587 Clinical Trial

Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance

Anesthesia Clinical Trial

Official title:
Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00522587
Other study ID # 2007/242
Secondary ID
Status Completed
Phase Phase 2
First received August 27, 2007
Last updated January 29, 2013
Start date April 2008
Est. completion date December 2011

Study information
Verified date January 2013
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2011
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Fixed sevoflurane dose 1
Dose 1 of sevoflurane
• Fixed sevoflurane dose 2
Dose 2 of sevoflurane
• Fixed sevoflurane dose 3
Dose 3 of sevoflurane
• Fixed sevoflurane dose 4
Dose 4 of sevoflurane
• Fixed sevoflurane dose 5
Dose 5 of sevoflurane
• Fixed sevoflurane dose 6
Dose 6 of sevoflurane
• Fixed remifentanil dose 1
Dose 1 of remifentanil
• Fixed remifentanil dose 2
Dose 2 of remifentanil
• Fixed remifentanil dose 3
Dose 3 of remifentanil
• Fixed remifentanil dose 4
Dose 4 of remifentanil
• Fixed remifentanil dose 5
Dose 5 of remifentanil
• Fixed remifentanil dose 6
Dose 6 of remifentanil

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary EEG depression and arousal reactions in response to different clinically relevant stimuli 60 to 90 minutes Yes
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