Dexmed/Buspirone Synergism on Shivering

NCT00334360 | Completed Phase 4

• 1 other identifier: Dexmed/Buspirone
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia

Outcome Measures

Primary Outcomes (3)

• Shivering threshold

  3 hours

• maximum intensity of shivering

  3 hours

• gain of shivering

  3 hours

Secondary Outcomes (1)

• hemodynamic responses

  3 hours

Study Arms (4)

1

EXPERIMENTAL

dexmedetomidine

Drug: dexmedetomidine

2

EXPERIMENTAL

Buspirone

Drug: buspirone

3

EXPERIMENTAL

Buspirone and dexmedetomidine

Drug: Bus and Dex

Control

PLACEBO COMPARATOR

No drug

Drug: Control

Interventions

dexmedetomidine DRUG

Dexmedetomidine (delivered by a computer-controlled IV infusion to target a plasma concentration of 0.6 ng/mL) will be given during controlled hypothermia

1

buspirone DRUG

Buspirone, 60 mg orally, will be given during controlled hypothermia.

2

Bus and Dex DRUG

the combination of 60 mg buspirone and dexmedetomidine (target plasma concentration of 0.6 ng/mL) will be given during controlled hypothermia

3

Control DRUG

No drugs given during controlled hypothermia

Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years
• normal weight (BMI \<35)
• healthy

You may not qualify if:

• obese (BMI \>35)
• taking any drugs
• thyroid disease, dysautonomia, or Raynaud's syndrome
• severe claustrophobia

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Outcomes Research Institute, University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Hypothermia

Interventions

Dexmedetomidine; Buspirone; Busulfan

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Pyrimidines; Polycyclic Compounds; Butylene Glycols; Glycols; Alcohols; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Rainer Lenhardt, MD, PhD

  University of Louisville School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2006
• First Posted: June 7, 2006
• Study Start: September 1, 2004
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: June 29, 2016

Record last verified: 2016-06

Locations

US (1)