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Dexmed/Buspirone Synergism on Shivering
This study has been completed.
First Received: June 6, 2006   Last Updated: March 26, 2008   History of Changes
Sponsor: Outcomes Research Consortium
Information provided by: Outcomes Research Consortium
ClinicalTrials.gov Identifier: NCT00334360
  Purpose

The purpose of this research is to determine if the combination of buspirone and dexmedetomidine are effective as a treatment to induce therapeutic hypothermia.

The design of the study includes four study days done in random order. The days are as follows: 1) Control (no drug); 2) Buspirone 60 mg orally; 3) Dexmedetomidine (delivered by a computer-controlled IV infusion to a target plasma concentration of 0.6 ng/ml); and, 3) the combination of buspirone 60 mg and dexmedetomidine (target plasma concentration of 0.6 ng/ml). a 20 cm-long catheter will be inserted into a cubital vein using standard aseptic technique In addition to the PIC line catheter, a simple peripheral catheter will be inserted into the other arm for drug administration.

Throughout the study period, mean-skin temperature will be maintained at 31°C by adjusting the temperature of circulating water (Cincinnati Sub-Zero, Cincinnati, OH) and forced-air warmers (Augustine Medical, Inc., Eden Prairie, MN). Furthermore, the back, upper-body, and lower-body will individually be maintained at the designated skin temperature. Lactated Ringer's solution cooled to ≈3°C will be infused via the PIC-line at rates sufficient to decrease tympanic membrane temperature ≈1.5°C/h. Fluid will be administered as long as oxygen consumption or electromyographic intensity (see below) continues to increase or a total of 5 liters of fluid is given. Heart rate will be measured continuously using an electrocardiogram; blood pressure will be determined oscillometrically at 5 min intervals at the ankle. In case heart rate and/or blood pressure changes unexpectedly (by more than 30% of the baseline), the study will stop and the volunteer will be re-warmed immediately.


Condition Intervention Phase
Hypothermia
Drug: dexmedetomidine
Drug: buspirone
Drug: Bus and Dex
Drug: Control
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Do Dexmedetomidine and Buspirone Synergistically Reduce the Threshold, Gain, and Maximum Intensity of Shivering?

Resource links provided by NLM:


Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • Shivering threshold
  • maximum intensity of shivering
  • gain of shivering

Secondary Outcome Measures:
  • hemodynamic responses

Enrollment: 8
Study Start Date: September 2004
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
dexmedetomidine
Drug: dexmedetomidine
Dexmedetomidine (delivered by a computer-controlled IV infusion to target a plasma concentration of 0.6 ng/mL) will be given during controlled hypothermia
2: Experimental
Buspirone
Drug: buspirone
Buspirone, 60 mg orally, will be given during controlled hypothermia.
3: Experimental
Buspirone and dexmedetomidine
Drug: Bus and Dex
the combination of 60 mg buspirone and dexmedetomidine (target plasma concentration of 0.6 ng/mL) will be given during controlled hypothermia
Control: Placebo Comparator
No drug
Drug: Control
No drugs given during controlled hypothermia

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-40 years
  • normal weight (BMI <35)
  • healthy

Exclusion Criteria:

  • obese (BMI >35)
  • taking any drugs
  • thyroid disease, dysautonomia, or Raynaud's syndrome
  • severe claustrophobia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334360

Locations
United States, Kentucky
Outcomes Research Institute, University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Principal Investigator: Rainer Lenhardt, MD, PhD University of Louisville School of Medicine
  More Information

No publications provided

Responsible Party: University of Louisville ( Rainer Lenhardt, MD )
Study ID Numbers: Dexmed/Buspirone
Study First Received: June 6, 2006
Last Updated: March 26, 2008
ClinicalTrials.gov Identifier: NCT00334360     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Serotonin Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Psychotropic Drugs
Body Temperature Changes
Adrenergic Agonists
Buspirone
Signs and Symptoms
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Dexmedetomidine
Analgesics
Hypothermia
Tranquilizing Agents
Adrenergic alpha-Agonists
Central Nervous System Depressants
Pharmacologic Actions
Serotonin Agents
Analgesics, Non-Narcotic
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009