Dexmed/Buspirone Synergism on Shivering

Hypothermia Clinical Trial

Official title:

Do Dexmedetomidine and Buspirone Synergistically Reduce the Threshold, Gain, and Maximum Intensity of Shivering?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334360
• Other study ID #: Dexmed/Buspirone
• Status: Completed
• Phase: Phase 4
• First received: June 6, 2006
• Last updated: June 27, 2016
• Start date: September 2004
• Est. completion date: August 2007

Study information

• Verified date: June 2016
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypothermia

Intervention

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
• buspirone
Buspirone, 60 mg orally, will be given during controlled hypothermia.
• 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
No drugs given during controlled hypothermia

Locations

Country	Name	City	State
United States	Outcomes Research Institute, University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shivering threshold		3 hours	No
Primary	maximum intensity of shivering		3 hours	No
Primary	gain of shivering		3 hours	No
Secondary	hemodynamic responses		3 hours	No