Dexmed/Buspirone Synergism on Shivering
Information source: Outcomes Research Consortium
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypothermia
Intervention: dexmedetomidine (Drug); buspirone (Drug); Bus and Dex (Drug); Control (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Outcomes Research Consortium Official(s) and/or principal investigator(s):
Rainer Lenhardt, MD, PhD, Principal Investigator, Affiliation: University of Louisville School of Medicine
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.
Clinical Details
Official title: Do Dexmedetomidine and Buspirone Synergistically Reduce the Threshold, Gain, and Maximum Intensity of Shivering?
Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Shivering thresholdmaximum intensity of shivering gain of shivering
Secondary outcome: hemodynamic responses
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Outcomes Research Institute, University of Louisville, Louisville, Kentucky 40202, United States
Additional Information
Starting date: September 2004
Ending date: August 2007
Last updated: March 26, 2008
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