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| 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? |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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 |
|
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 |