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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: | 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? |
| 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 |
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: | 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 |
|
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 |