Dexmed/Buspirone Synergism on Shivering

Phase 4

Completed

• Conditions: Hypothermia
• Interventions: Drug: dexmedetomidine; Drug: Bus and Dex; Drug: Control; Drug: buspirone

• Registration Number: NCT00334360
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2006-06-06
• Study First Submitted QC: 2006-06-06
• Study First Posted: 2006-06-07
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-27
• Last Update Posted: 2016-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	dexmedetomidine	dexmedetomidine
3	Bus and Dex	Buspirone and dexmedetomidine
Control	Control	No drug
2	buspirone	Buspirone

Primary Outcome Measures

Name	Time	Method
Shivering threshold	3 hours
maximum intensity of shivering	3 hours
gain of shivering	3 hours

Secondary Outcome Measures

Name	Time	Method
hemodynamic responses	3 hours

Trial Locations

Locations (1)

Outcomes Research Institute, University of Louisville; 🇺🇸 Louisville, Kentucky, United States