Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
8 participants
INTERVENTIONAL
2004-09-30
2007-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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1
dexmedetomidine
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
2
Buspirone
buspirone
Buspirone, 60 mg orally, will be given during controlled hypothermia.
3
Buspirone and dexmedetomidine
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
Control
No drug
Control
No drugs given during controlled hypothermia
Interventions
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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
buspirone
Buspirone, 60 mg orally, will be given during controlled hypothermia.
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
Control
No drugs given during controlled hypothermia
Eligibility Criteria
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Inclusion Criteria
* normal weight (BMI \<35)
* healthy
Exclusion Criteria
* taking any drugs
* thyroid disease, dysautonomia, or Raynaud's syndrome
* severe claustrophobia
18 Years
40 Years
MALE
Yes
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Principal Investigators
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Rainer Lenhardt, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville School of Medicine
Locations
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Outcomes Research Institute, University of Louisville
Louisville, Kentucky, United States
Countries
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Other Identifiers
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Dexmed/Buspirone
Identifier Type: -
Identifier Source: org_study_id
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