Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance
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| ClinicalTrials.gov Identifier: NCT00522587 |
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Recruitment Status
:
Completed
First Posted
: August 29, 2007
Last Update Posted
: January 30, 2013
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Sponsor:
University Hospital, Ghent
Information provided by (Responsible Party):
University Hospital, Ghent
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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 |
|---|---|
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Experimental: 1
Fixed sevoflurane dose 1
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Drug: Fixed sevoflurane dose 1
Dose 1 of sevoflurane
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Experimental: 2
Fixed sevoflurane dose 2
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Drug: Fixed sevoflurane dose 2
Dose 2 of sevoflurane
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Experimental: 3
Fixed sevoflurane dose 3
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Drug: Fixed sevoflurane dose 3
Dose 3 of sevoflurane
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Experimental: 4
Fixed sevoflurane dose 4
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Drug: Fixed sevoflurane dose 4
Dose 4 of sevoflurane
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Experimental: 5
Fixed sevoflurane dose 5
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Drug: Fixed sevoflurane dose 5
Dose 5 of sevoflurane
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Experimental: 6
Fixed sevoflurane dose 6
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Drug: Fixed sevoflurane dose 6
Dose 6 of sevoflurane
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Experimental: 7
Fixed remifentanil dose 1
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Drug: Fixed remifentanil dose 1
Dose 1 of remifentanil
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Experimental: 8
Fixed remifentanil dose 2
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Drug: Fixed remifentanil dose 2
Dose 2 of remifentanil
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Experimental: 9
Fixed remifentanil dose 3
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Drug: Fixed remifentanil dose 3
Dose 3 of remifentanil
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Experimental: 10
Fixed remifentanil dose 4
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Drug: Fixed remifentanil dose 4
Dose 4 of remifentanil
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Experimental: 11
Fixed remifentanil dose 5
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Drug: Fixed remifentanil dose 5
Dose 5 of remifentanil
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Experimental: 12
Fixed remifentanil dose 6
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Drug: Fixed remifentanil dose 6
Dose 6 of remifentanil
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Primary Outcome Measures
:
- EEG depression and arousal reactions in response to different clinically relevant stimuli [ Time Frame: 60 to 90 minutes ]
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| 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:
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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 |