Dexmed/Buspirone Synergism on Shivering - Tabular View

Tracking Information

First Received Date ^ICMJE

June 6, 2006

Last Updated Date

March 26, 2008

Start Date ^ICMJE

September 2004

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Shivering threshold
maximum intensity of shivering
gain of shivering

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00334360 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

hemodynamic responses

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Dexmed/Buspirone Synergism on Shivering

Official Title ^ICMJE

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

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hypothermia

Intervention ^ICMJE

Drug: dexmedetomidine
Drug: buspirone
Drug: Bus and Dex
Drug: Control

Study Arms / Comparison Groups

Experimental: dexmedetomidine
Experimental: Buspirone
Experimental: Buspirone and dexmedetomidine
Placebo Comparator: No drug

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2007

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00334360

Responsible Party

Rainer Lenhardt, MD, University of Louisville

Study ID Numbers ^ICMJE

Dexmed/Buspirone

Study Sponsor ^ICMJE

Outcomes Research Consortium

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Rainer Lenhardt, MD, PhD

University of Louisville School of Medicine

Information Provided By

Outcomes Research Consortium

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP