Trial | NCT00852046  Report issue

Title

Adjunct Dexmedetomidine (Precedex®) Therapy Impact on Sedative and Analgesic Requirement
Adjunct Dexmedetomidine Therapy Impact on Sedative and Analgesic

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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.
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.
Study Started
Feb 28
2009
Primary Completion
Mar 31
2009
Study Completion
Mar 31
2009
Last Update
Oct 06
2011
Estimate

Drug Dexmedetomidine

IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days

  • Other names: Precedex

1. Low dose dexmedetomidine Experimental

Dexmedetomidine 0.2 mcg/kg/hr added to fentanyl & propofol.

2. High dose dexmedetomidine Experimental

Dexmedetomidine 0.6 mcg/kg/hr added to fentanyl & propofol.

3. Placebo Placebo Comparator

Placebo added to fentanyl & propofol.

Criteria 

Inclusion Criteria:

surgical, medical, or trauma patients requiring sedation for mechanical ventilation
age 18-80
Anticipated ventilation time of > 24 hrs
Reasonable chance of recovery

Exclusion Criteria:

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
No Results Posted