Dexmed/Buspirone Synergism on Shivering

NeuroTherapia, Inc.

Status and phase: Completed; Phase 4

Conditions: Hypothermia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00334360

Dexmed/Buspirone

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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8 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

dexmedetomidine

Treatment:

Drug: dexmedetomidine

2

Experimental group

Description:

Buspirone

Treatment:

Drug: buspirone

3

Experimental group

Description:

Buspirone and dexmedetomidine

Treatment:

Drug: Bus and Dex

Control

Placebo Comparator group

Description:

No drug

Treatment:

Drug: Control