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

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2005

Detailed Description

To examine the possible synergistic effects og systemic remifentanil and clonidine. Its effects on respiration, cognitive function and sedation.

Interventions

  • Drug: Remifentanil+clonidine
    • iv Remifentanil+ iv clonidine

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Clonidine
  • Active Comparator: 2
    • Remifentanil
  • Experimental: 4
    • Remifentanil+clonidine
  • Placebo Comparator: 3
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Relief of pain(VAS reduction)
    • Time Frame: Experimental

Secondary Measures

  • Reduction in Minute ventilation
    • Time Frame: Experimental
  • Reduction in CO2 stimulated Minute Ventilation
    • Time Frame: experimental
  • Reduction in BIS score
    • Time Frame: Experimental
  • Performance on Stroop test
    • Time Frame: Experimental

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy volunteers Exclusion Criteria:

-

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Oslo University Hospital
  • Provider of Information About this Clinical Study
    • Dr. Jon Bragi Bergmann, Dep.of anasthesiology, Rikshospitalet, Oslo, Norway
  • Overall Official(s)
    • Jon B Bergmann, Ass. Prof., Principal Investigator, Dep of Anesthesia and Intensive Care, Rikshospitalet-Radiumhospitalet Medical Center

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