Analgesia, Sedation
Conditions
Keywords
Mechanical ventilation
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.
Interventions
DRUGDexmedetomidine
IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days
Sponsors
Avera McKennan Hospital & University Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total daily dose of fentanyl and propofol | Daily |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
Outcome results
None listed