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Dexmed/Buspirone Synergism on Shivering

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

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334360


Locations
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United States, Kentucky
Outcomes Research Institute, University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Rainer Lenhardt, MD, PhD University of Louisville School of Medicine
More Information
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00334360     History of Changes
Other Study ID Numbers: Dexmed/Buspirone
First Posted: June 7, 2006    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes
Signs and Symptoms
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