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

July 3, 2011 updated by: Oslo University Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0027
        • Dep of Anesthesia and Intensive Care, Rikshospitalet-Radiumhospitalet Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3
Placebo
Drug: Remifentanil+clonidine
iv Remifentanil+ iv clonidine
Other Names:
  • Ultiva, Catapressan
Active Comparator: 1
Clonidine
Drug: Remifentanil+clonidine
iv Remifentanil+ iv clonidine
Other Names:
  • Ultiva, Catapressan
Active Comparator: 2
Remifentanil
Drug: Remifentanil+clonidine
iv Remifentanil+ iv clonidine
Other Names:
  • Ultiva, Catapressan
Experimental: 4
Remifentanil+clonidine
Drug: Remifentanil+clonidine
iv Remifentanil+ iv clonidine
Other Names:
  • Ultiva, Catapressan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relief of pain(VAS reduction)
Time Frame: Experimental
Experimental

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Jon B Bergmann, Ass. Prof., Dep of Anesthesia and Intensive Care, Rikshospitalet-Radiumhospitalet Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

August 6, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

July 6, 2011

Last Update Submitted That Met QC Criteria

July 3, 2011

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-03025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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