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

Purpose

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.

Condition	Intervention	Phase
Acute Pain Respiration Sedation	Drug: Remifentanil+clonidine	Phase I Phase II

Drug Information available for:

Clonidine Remifentanil Remifentanil hydrochloride Clonidine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

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

Further study details as provided by Rikshospitalet-Radiumhospitalet HF:

Primary Outcome Measures:

Relief of pain(VAS reduction) [ Time Frame: Experimental ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction in Minute ventilation [ Time Frame: Experimental ] [ Designated as safety issue: Yes ]
Reduction in CO2 stimulated Minute Ventilation [ Time Frame: experimental ] [ Designated as safety issue: Yes ]
Reduction in BIS score [ Time Frame: Experimental ] [ Designated as safety issue: No ]
Performance on Stroop test [ Time Frame: Experimental ] [ Designated as safety issue: No ]

Enrollment:	12
Study Start Date:	February 2005
Study Completion Date:	May 2005
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Clonidine	Drug: Remifentanil+clonidine iv Remifentanil+ iv clonidine
2: Active Comparator Remifentanil	Drug: Remifentanil+clonidine iv Remifentanil+ iv clonidine
4: Experimental Remifentanil+clonidine	Drug: Remifentanil+clonidine iv Remifentanil+ iv clonidine
3: Placebo Comparator Placebo	Drug: Remifentanil+clonidine iv Remifentanil+ iv clonidine

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy volunteers

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730054

Locations


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

Sponsors and Collaborators

Rikshospitalet-Radiumhospitalet HF

Investigators


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

More Information

Responsible Party:	Dep.of anasthesiology, Rikshospitalet, Oslo, Norway ( Dr. Jon Bragi Bergmann )
Study ID Numbers:	S-03025
First Received:	August 6, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00730054
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by Rikshospitalet-Radiumhospitalet HF:

Remifentanil

clonidine

acute pain

respiration

sedation

cognitive function

Study placed in the following topic categories:

Remifentanil

Clonidine

Pain

Healthy

Additional relevant MeSH terms:

Anesthetics, Intravenous

Sympatholytics

Neurotransmitter Agents

Adrenergic alpha-Agonists

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Anesthetics

Central Nervous System Depressants

Cardiovascular Agents

Antihypertensive Agents

Adrenergic Agonists

Pharmacologic Actions

Anesthetics, General

Autonomic Agents

Sensory System Agents

Therapeutic Uses

Hypnotics and Sedatives

Analgesics

Peripheral Nervous System Agents

Central Nervous System Agents

Analgesics, Opioid

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Rikshospitalet-Radiumhospitalet HF
Information provided by:	Rikshospitalet-Radiumhospitalet HF
ClinicalTrials.gov Identifier:	NCT00730054