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Sponsored by: |
Outcomes Research Consortium |
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Information provided by: | Outcomes Research Consortium |
ClinicalTrials.gov Identifier: | NCT00334360 |
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 |
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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? |
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 |
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1: Experimental
dexmedetomidine
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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
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2: Experimental
Buspirone
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Drug: buspirone
Buspirone, 60 mg orally, will be given during controlled hypothermia.
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3: Experimental
Buspirone and dexmedetomidine
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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
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Control: Placebo Comparator
No drug
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Drug: Control
No drugs given during controlled hypothermia
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Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Kentucky | |
Outcomes Research Institute, University of Louisville | |
Louisville, Kentucky, United States, 40202 |
Principal Investigator: | Rainer Lenhardt, MD, PhD | University of Louisville School of Medicine |
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 |
Health Authority: | United States: Institutional Review Board |
Buspirone Signs and Symptoms Hypothermia Dexmedetomidine Serotonin |
Serotonin Agonists Neurotransmitter Agents Adrenergic alpha-Agonists Tranquilizing Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Body Temperature Changes Adrenergic Agonists |
Pharmacologic Actions Serotonin Agents Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Hypnotics and Sedatives Anti-Anxiety Agents Peripheral Nervous System Agents Analgesics Central Nervous System Agents |