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

Sponsored by:	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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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: Anesthesia

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 [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Fixed sevoflurane dose 1	Drug: Fixed sevoflurane dose 1 Dose 1 of sevoflurane
2: Experimental Fixed sevoflurane dose 2	Drug: Fixed sevoflurane dose 2 Dose 2 of sevoflurane
3: Experimental Fixed sevoflurane dose 3	Drug: Fixed sevoflurane dose 3 Dose 3 of sevoflurane
4: Experimental Fixed sevoflurane dose 4	Drug: Fixed sevoflurane dose 4 Dose 4 of sevoflurane
5: Experimental Fixed sevoflurane dose 5	Drug: Fixed sevoflurane dose 5 Dose 5 of sevoflurane
6: Experimental Fixed sevoflurane dose 6	Drug: Fixed sevoflurane dose 6 Dose 6 of sevoflurane
7: Experimental Fixed remifentanil dose 1	Drug: Fixed remifentanil dose 1 Dose 1 of remifentanil
8: Experimental Fixed remifentanil dose 2	Drug: Fixed remifentanil dose 2 Dose 2 of remifentanil
9: Experimental Fixed remifentanil dose 3	Drug: Fixed remifentanil dose 3 Dose 3 of remifentanil
10: Experimental Fixed remifentanil dose 4	Drug: Fixed remifentanil dose 4 Dose 4 of remifentanil
11: Experimental Fixed remifentanil dose 5	Drug: Fixed remifentanil dose 5 Dose 5 of remifentanil
12: Experimental 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:	University Hospital Ghent ( Michel Struys, MD, PhD )
Study ID Numbers:	2007/242
Study First Received:	August 27, 2007
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00522587 History of Changes
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Study placed in the following topic categories:

Anesthetics, Intravenous
Anesthetics, Inhalation
Remifentanil
Anesthetics, General
Hypnotics and Sedatives
Central Nervous System Depressants

Anesthetics
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid
Sevoflurane

Additional relevant MeSH terms:

Anesthetics, Intravenous
Remifentanil
Hematologic Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Pharmacologic Actions
Sevoflurane
Anesthetics, Inhalation

Sensory System Agents
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 02, 2009