Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers

Verified by: Oslo University Hospital, August 2008
First Received: August 6, 2008 | Last Updated: July 3, 2011 | Phase: Phase 1/Phase 2 | Start Date: February 2005
Overall Status: Completed | Estimated Enrollment: 12
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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...

Brief Summary

Official Title: “Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers”

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • 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

Secondary Measures

  • Reduction in Minute ventilation
    • Time Frame: Experimental
      Safety Issue?: Yes
  • Reduction in CO2 stimulated Minute Ventilation
    • Time Frame: experimental
      Safety Issue?: Yes
  • Reduction in BIS score
    • Time Frame: Experimental
      Safety Issue?: No
  • Performance on Stroop test
    • Time Frame: Experimental
      Safety Issue?: No

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 Investigator Information

Lead Investigator: Oslo University Hospital Other

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 February 08, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00730054