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

Tracking Information

First Received Date ^ICMJE

August 27, 2007

Last Updated Date

April 9, 2009

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

EEG depression and arousal reactions in response to different clinically relevant stimuli [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00522587 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Anesthesia

Intervention ^ICMJE

Drug: 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

Study Arms / Comparison Groups

Experimental: Fixed sevoflurane dose 1
Experimental: Fixed sevoflurane dose 2
Experimental: Fixed sevoflurane dose 3
Experimental: Fixed sevoflurane dose 4
Experimental: Fixed sevoflurane dose 5
Experimental: Fixed sevoflurane dose 6
Experimental: Fixed remifentanil dose 1
Experimental: Fixed remifentanil dose 2
Experimental: Fixed remifentanil dose 3
Experimental: Fixed remifentanil dose 4
Experimental: Fixed remifentanil dose 5
Experimental: Fixed remifentanil dose 6

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Michel Struys, MD, PhD

+ 32 9 332 49 55

michel.struys@ugent.be

Location Countries ^ICMJE

Belgium

Administrative Information

NCT ID ^ICMJE

NCT00522587

Responsible Party

Michel Struys, MD, PhD, University Hospital Ghent

Study ID Numbers ^ICMJE

2007/242

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Michel Struys, MD, PhD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP