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Dexmed/Buspirone Synergism on Shivering
This study has been completed.

First Received on June 6, 2006.   Last Updated on 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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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
Experimental: 1
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
Experimental: 2
Buspirone
Drug: buspirone
Buspirone, 60 mg orally, will be given during controlled hypothermia.
Experimental: 3
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
Placebo Comparator: Control
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: Rainer Lenhardt, MD, University of Louisville
ClinicalTrials.gov Identifier: NCT00334360     History of Changes
Other Study ID Numbers: Dexmed/Buspirone
Study First Received: June 6, 2006
Last Updated: March 26, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms
Buspirone
Dexmedetomidine
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on February 12, 2012