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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:
ClinicalTrials.gov Identifier:
NCT00730054
First Posted: August 8, 2008
Last Update Posted: July 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Oslo University Hospital
  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
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Relief of pain(VAS reduction) [ Time Frame: Experimental ]

Secondary Outcome Measures:
  • Reduction in Minute ventilation [ Time Frame: Experimental ]
  • Reduction in CO2 stimulated Minute Ventilation [ Time Frame: experimental ]
  • Reduction in BIS score [ Time Frame: Experimental ]
  • Performance on Stroop test [ Time Frame: Experimental ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 6, 2008
First Posted: August 8, 2008
Last Update Posted: July 6, 2011
Last Verified: August 2008

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

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Remifentanil
Clonidine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action