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

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00730054
First received: August 6, 2008
Last updated: July 3, 2011
Last verified: August 2008
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

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
Active Comparator: 1
Clonidine
 Drug: Remifentanil+clonidine
iv Remifentanil+ iv clonidine
Other Name: Ultiva, Catapressan
Active Comparator: 2
Remifentanil
 Drug: Remifentanil+clonidine
iv Remifentanil+ iv clonidine
Other Name: Ultiva, Catapressan
Experimental: 4
Remifentanil+clonidine
 Drug: Remifentanil+clonidine
iv Remifentanil+ iv clonidine
Other Name: Ultiva, Catapressan
Placebo Comparator: 3
Placebo
 Drug: Remifentanil+clonidine
iv Remifentanil+ iv clonidine
Other Name: Ultiva, Catapressan

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
Oslo University Hospital
Investigators
Principal Investigator: Jon B Bergmann, Ass. Prof. Dep of Anesthesia and Intensive Care, Rikshospitalet-Radiumhospitalet Medical Center
  More Information

No publications provided

Responsible Party: Dr. Jon Bragi Bergmann, Dep.of anasthesiology, Rikshospitalet, Oslo, Norway
ClinicalTrials.gov Identifier: NCT00730054     History of Changes
Other Study ID Numbers: S-03025
Study First Received: August 6, 2008
Last Updated: July 3, 2011
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
Remifentanil
clonidine
acute pain
 respiration
sedation
cognitive function

Additional relevant MeSH terms:
Clonidine
Remifentanil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Central Nervous System Agents
Analgesics, Opioid
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on June 18, 2013