The hypothesis is that systemic remifentanil and Clonidine act in a synergistic manner to relief acute main in an experimental human pain model. Of interest is also the effect of the combination on respiration, sedation and cognitive behavior...
Date First Received: August 6, 2008
Last Updated: August 7, 2008
Verified by: Rikshospitalet HF, August 2008
Clinical Trial Phase: Phase 1/Phase 2 | Start Date: February 2005
Overall Status: Completed
Estimated Enrollment: 12
Brief Summary
Official Title: “Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers”
Condition Keyword(s):
Intervention(s):
The hypothesis is that systemic remifentanil and Clonidine act in a synergistic manner to relief acute main in an experimental human pain model. Of interest is also the effect of the combination on respiration, sedation and cognitive behavior.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Study Primary Completion Date: May 2005
Detailed Clinical Trial Description
To examine the possible synergistic effects og systemic remifentanil and clonidine. Its effects on respiration, cognitive function and sedation.
Intervention(s) in this Clinical Trial
- Drug: Remifentanil+clonidine
- iv Remifentanil+ iv clonidine
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Clonidine
- Active Comparator: 2
- Remifentanil
- Experimental: 4
- Remifentanil+clonidine
- Placebo Comparator: 3
- Placebo
Outcome Measures for this Clinical Trial
Primary Measures
- Relief of pain(VAS reduction)
- Time Frame: Experimental
Safety Issue?: No
- Time Frame: Experimental
Secondary Measures
- Reduction in Minute ventilation
- Time Frame: Experimental
Safety Issue?: Yes
- Time Frame: Experimental
- Reduction in CO2 stimulated Minute Ventilation
- Time Frame: experimental
Safety Issue?: Yes
- Time Frame: experimental
- Reduction in BIS score
- Time Frame: Experimental
Safety Issue?: No
- Time Frame: Experimental
- Performance on Stroop test
- Time Frame: Experimental
Safety Issue?: No
- Time Frame: Experimental
Criteria for Participation in this Clinical Trial
- Inclusion Criteria: - Healthy volunteers Exclusion Criteria: -
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 50 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Rikshospitalet HF
Overall Clinical Trial Officials and Contacts
Jon B Bergmann, Ass. Prof. Principal Investigator Dep of Anesthesia and Intensive Care, Rikshospitalet-Radiumhospitalet Medical Center
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00730054
Study ID Number: S-03025
ClinicalTrials.gov Identifier: NCT00730054
Health Authority: Norway: Norwegian Medicines Agency
Clinical Trials Authorship and Review
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