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

Primary Purpose

Acute Pain, Respiration, Sedation

Status

Completed

Phase

Phase 1

Locations

Norway

Study Type

Interventional

Intervention

Remifentanil+clonidine

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring Remifentanil, clonidine, acute pain, respiration, sedation, cognitive function

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy volunteers

Exclusion Criteria:

Sites / Locations

Dep of Anesthesia and Intensive Care, Rikshospitalet-Radiumhospitalet Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Arm Description

Clonidine

Remifentanil

Remifentanil+clonidine

Placebo

Outcomes

Primary Outcome Measures

Relief of pain(VAS reduction)

Secondary Outcome Measures

Reduction in Minute ventilation

Reduction in CO2 stimulated Minute Ventilation

Reduction in BIS score

Performance on Stroop test

Full Information

NCT ID

NCT00730054

First Posted

August 6, 2008

Last Updated

July 3, 2011

Sponsor

Oslo University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00730054

Brief Title

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

Acronym

Remiclon

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Completed

Study Start Date

February 2005 (undefined)

Primary Completion Date

May 2005 (Actual)

Study Completion Date

May 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Oslo University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Pain, Respiration, Sedation

Keywords

Remifentanil, clonidine, acute pain, respiration, sedation, cognitive function

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Clonidine

Arm Title

Arm Type

Active Comparator

Arm Description

Remifentanil

Arm Title

Arm Type

Experimental

Arm Description

Remifentanil+clonidine

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Remifentanil+clonidine

Other Intervention Name(s)

Ultiva, Catapressan

Intervention Description

iv Remifentanil+ iv clonidine

Primary Outcome Measure Information:

Title

Relief of pain(VAS reduction)

Time Frame

Experimental

Secondary Outcome Measure Information:

Title

Reduction in Minute ventilation

Time Frame

Experimental

Title

Reduction in CO2 stimulated Minute Ventilation

Time Frame

experimental

Title

Reduction in BIS score

Time Frame

Experimental

Title

Performance on Stroop test

Time Frame

Experimental

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy volunteers Exclusion Criteria: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jon B Bergmann, Ass. Prof.

Organizational Affiliation

Dep of Anesthesia and Intensive Care, Rikshospitalet-Radiumhospitalet Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dep of Anesthesia and Intensive Care, Rikshospitalet-Radiumhospitalet Medical Center

City

Oslo

ZIP/Postal Code

0027

Country

Norway

12. IPD Sharing Statement

Learn more about this trial

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

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