Dexmed/Buspirone Synergism on Shivering

• ClinicalTrials.gov Identifier: NCT00334360
• Recruitment Status: Completed
• First Posted: June 7, 2006
• Last Update Posted: June 29, 2016
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): The Cleveland Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypothermia	Drug: dexmedetomidine; Drug: buspirone; Drug: Bus and Dex; Drug: Control	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; dexmedetomidine	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
Experimental: 2; Buspirone	Drug: buspirone; Buspirone, 60 mg orally, will be given during controlled hypothermia.
Experimental: 3; 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 drug	Drug: Control; No drugs given during controlled hypothermia

Outcome Measures

Primary Outcome Measures :

1. Shivering threshold [ Time Frame: 3 hours ]
2. maximum intensity of shivering [ Time Frame: 3 hours ]
3. gain of shivering [ Time Frame: 3 hours ]

Secondary Outcome Measures :

1. hemodynamic responses [ Time Frame: 3 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Kentucky

Outcomes Research Institute, University of Louisville

Louisville, Kentucky, United States, 40202

Sponsors and Collaborators

The Cleveland Clinic

Investigators

• Principal Investigator: Rainer Lenhardt, MD, PhD; University of Louisville School of Medicine

More Information

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT00334360
• Other Study ID Numbers: Dexmed/Buspirone
• First Posted: June 7, 2006
• Last Update Posted: June 29, 2016
• Last Verified: June 2016

Additional relevant MeSH terms:

Hypothermia; Body Temperature Changes; Dexmedetomidine; Buspirone; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Receptor Agonists; Serotonin Agents