Adjunct Dexmedetomidine (Precedex®) Therapy Impact on Sedative and Analgesic Requirement
- Registration Number
- NCT00852046
- Lead Sponsor
- Avera McKennan Hospital & University Health Center
- Brief Summary
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.
- Detailed Description
Patients identified by selection criteria within 48 hours of intubation will be randomly assigned to one of three study arms: dexmedetomidine 0.2 mcg/kg/hr, dexmedetomidine 0.6 mcg/kg/hr, or placebo. If not already on, patients will be converted to propofol and fentanyl for sedation and analgesia, which will be titrated to a goal SAS score of 3-4.
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- surgical, medical, or trauma patients requiring sedation for mechanical ventilation
- age 18-80
- Anticipated ventilation time of > 24 hrs
- Reasonable chance of recovery
- Severe COPD
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2. High dose dexmedetomidine Dexmedetomidine Dexmedetomidine 0.6 mcg/kg/hr added to fentanyl \& propofol. 1. Low dose dexmedetomidine Dexmedetomidine Dexmedetomidine 0.2 mcg/kg/hr added to fentanyl \& propofol. 3. Placebo Dexmedetomidine Placebo added to fentanyl \& propofol.
- Primary Outcome Measures
Name Time Method Total daily dose of fentanyl and propofol Daily
- Secondary Outcome Measures
Name Time Method Total ventilation time Study ended ICU length of stay Study ended. Hospital length of stay Study ended Patient outcomes/mortality Study ended. Total pharmacy expenditures Study ended.