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

Acute Pain Clinical Trial

— Remiclon  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730054
• Other study ID #: S-03025
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 6, 2008
• Last updated: July 3, 2011
• Start date: February 2005
• Est. completion date: May 2005

Study information

• Verified date: August 2008
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

• Acute Pain
• Respiration
• Sedation

Intervention

Drug:
• Remifentanil+clonidine
iv Remifentanil+ iv clonidine

Locations

Country	Name	City	State
Norway	Dep of Anesthesia and Intensive Care, Rikshospitalet-Radiumhospitalet Medical Center	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief of pain(VAS reduction)		Experimental	No
Secondary	Reduction in Minute ventilation		Experimental	Yes
Secondary	Reduction in CO2 stimulated Minute Ventilation		experimental	Yes
Secondary	Reduction in BIS score		Experimental	No
Secondary	Performance on Stroop test		Experimental	No