Dexmed/Buspirone Synergism on Shivering
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|ClinicalTrials.gov Identifier: NCT00334360|
Recruitment Status : Completed
First Posted : June 7, 2006
Last Update Posted : June 29, 2016
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 or disease||Intervention/treatment||Phase|
|Hypothermia||Drug: dexmedetomidine Drug: buspirone Drug: Bus and Dex Drug: Control||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Do Dexmedetomidine and Buspirone Synergistically Reduce the Threshold, Gain, and Maximum Intensity of Shivering?|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||August 2007|
Dexmedetomidine (delivered by a computer-controlled IV infusion to target a plasma concentration of 0.6 ng/mL) will be given during controlled hypothermia
Buspirone, 60 mg orally, will be given during controlled hypothermia.
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 drugs given during controlled hypothermia
- Shivering threshold [ Time Frame: 3 hours ]
- maximum intensity of shivering [ Time Frame: 3 hours ]
- gain of shivering [ Time Frame: 3 hours ]
- hemodynamic responses [ Time Frame: 3 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334360
|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|