Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance
This study has been completed.
Sponsor:
University Hospital, Ghent
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00522587
First received: August 27, 2007
Last updated: January 29, 2013
Last verified: January 2013
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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 2 |
| 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:
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 ]
| Enrollment: | 40 |
| Study Start Date: | April 2008 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | July 2009 (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 (Adult) |
| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522587
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Additional Information:
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT00522587 History of Changes |
| Other Study ID Numbers: | 2007/242 |
| Study First Received: | August 27, 2007 |
| Last Updated: | January 29, 2013 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
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 |
ClinicalTrials.gov processed this record on September 28, 2016