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

Sponsor:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00522587

Purpose

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

Condition	Intervention	Phase
Anesthesia	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	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Sevoflurane Remifentanil hydrochloride Remifentanil

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

EEG depression and arousal reactions in response to different clinically relevant stimuli [ Time Frame: 60 to 90 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	December 2007
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Fixed sevoflurane dose 1	Drug: Fixed sevoflurane dose 1 Dose 1 of sevoflurane
Experimental: 2 Fixed sevoflurane dose 2	Drug: Fixed sevoflurane dose 2 Dose 2 of sevoflurane
Experimental: 3 Fixed sevoflurane dose 3	Drug: Fixed sevoflurane dose 3 Dose 3 of sevoflurane
Experimental: 4 Fixed sevoflurane dose 4	Drug: Fixed sevoflurane dose 4 Dose 4 of sevoflurane
Experimental: 5 Fixed sevoflurane dose 5	Drug: Fixed sevoflurane dose 5 Dose 5 of sevoflurane
Experimental: 6 Fixed sevoflurane dose 6	Drug: Fixed sevoflurane dose 6 Dose 6 of sevoflurane
Experimental: 7 Fixed remifentanil dose 1	Drug: Fixed remifentanil dose 1 Dose 1 of remifentanil
Experimental: 8 Fixed remifentanil dose 2	Drug: Fixed remifentanil dose 2 Dose 2 of remifentanil
Experimental: 9 Fixed remifentanil dose 3	Drug: Fixed remifentanil dose 3 Dose 3 of remifentanil
Experimental: 10 Fixed remifentanil dose 4	Drug: Fixed remifentanil dose 4 Dose 4 of remifentanil
Experimental: 11 Fixed remifentanil dose 5	Drug: Fixed remifentanil dose 5 Dose 5 of remifentanil
Experimental: 12 Fixed remifentanil dose 6	Drug: Fixed remifentanil dose 6 Dose 6 of remifentanil

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522587

Contacts

Contact: Michel Struys, MD, PhD

+ 32 9 332 49 55

michel.struys@ugent.be

Locations

Belgium
University Hospital Ghent	Recruiting
Ghent, Belgium, 9000
Contact: Michel Struys, MD, PhD + 32 9 332 49 55 michel.struys@ugent.be
Principal Investigator: Michel Struys, MD, PhD

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator:

Michel Struys, MD, PhD

University Hospital, Ghent

More Information

Additional Information:

Website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Michel Struys, MD, PhD, University Hospital Ghent
ClinicalTrials.gov Identifier:	NCT00522587 History of Changes
Other Study ID Numbers:	2007/242
Study First Received:	August 27, 2007
Last Updated:	August 16, 2011
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:

Sevoflurane
Remifentanil
Analgesics, Opioid
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Inhalation
Anesthetics, General

Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous

ClinicalTrials.gov processed this record on February 12, 2012