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

Phase 1

Completed

• Conditions: Acute Pain; Respiration; Sedation
• Interventions: Drug: Remifentanil+clonidine

• Registration Number: NCT00730054
• Lead Sponsor: Oslo University Hospital

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Status Verified: 2008-08
• Study First Submitted: 2008-08-06
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Last Update Submitted: 2011-07-03
• Last Update Posted: 2011-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Healthy volunteers

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Remifentanil+clonidine	Clonidine
2	Remifentanil+clonidine	Remifentanil
4	Remifentanil+clonidine	Remifentanil+clonidine
3	Remifentanil+clonidine	Placebo

Primary Outcome Measures

Name	Time	Method
Relief of pain(VAS reduction)	Experimental

Secondary Outcome Measures

Name	Time	Method
Reduction in Minute ventilation	Experimental
Reduction in CO2 stimulated Minute Ventilation	experimental
Reduction in BIS score	Experimental
Performance on Stroop test	Experimental

Trial Locations

Locations (1)

Dep of Anesthesia and Intensive Care, Rikshospitalet-Radiumhospitalet Medical Center; 🇳🇴 Oslo, Norway