Adjunct Dexmedetomidine (Precedex®) Therapy Impact on Sedative and Analgesic Requirement
NCT ID: NCT00852046
Last Updated: 2011-10-06
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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WITHDRAWN
PHASE4
INTERVENTIONAL
2009-02-28
2009-03-31
Brief Summary
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Detailed Description
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Patients will be monitored, assessed, and evaluated by all regular policies and procedures of the institution. Extubation will be at the discretion of the physicians and medical team caring for the patient. If the patient is still intubated at five days study drug will then be stopped and further use of dexmedetomidine will be at the discretion of the physicians.
Primary objective will assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and propofol while maintaining sedation in a mechanically ventilated patient in a general medical intensive care unit.
Secondary objectives include total ventilation time, ICU length of stay, hospital length of stay, patient outcomes/mortality, and total pharmacy expenditures.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1. Low dose dexmedetomidine
Dexmedetomidine 0.2 mcg/kg/hr added to fentanyl \& propofol.
Dexmedetomidine
IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days
2. High dose dexmedetomidine
Dexmedetomidine 0.6 mcg/kg/hr added to fentanyl \& propofol.
Dexmedetomidine
IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days
3. Placebo
Placebo added to fentanyl \& propofol.
Dexmedetomidine
IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days
Interventions
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Dexmedetomidine
IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age 18-80
* Anticipated ventilation time of \> 24 hrs
* Reasonable chance of recovery
Exclusion Criteria
* Chronic immunosuppression (equivalent to prednisone 7.5 mg daily or higher)
* Heart block
* Bradycardia
* Significant head injury
* Goal SAS score of 1-2
* Severe hepatic impairment
* Hypertriglyceridemia
* Allergy to dexmedetomidine, fentanyl, propofol or eggs
18 Years
80 Years
ALL
No
Sponsors
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Avera McKennan Hospital & University Health Center
OTHER
Responsible Party
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Principal Investigators
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John A Kappes, Pharm.D.
Role: PRINCIPAL_INVESTIGATOR
Avera McKennan Hospital
Other Identifiers
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#2008.071
Identifier Type: -
Identifier Source: org_study_id