ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00522587
Recruitment Status : Completed
First Posted : August 29, 2007
Last Update Posted : January 30, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

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

Condition or disease Intervention/treatment 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 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. EEG depression and arousal reactions in response to different clinically relevant stimuli [ Time Frame: 60 to 90 minutes ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522587


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Michel Struys, MD, PhD University Hospital, Ghent

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00522587     History of Changes
Other Study ID Numbers: 2007/242
First Posted: August 29, 2007    Key Record Dates
Last Update Posted: January 30, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Remifentanil
Sevoflurane
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation