A Double-blinded Randomized Controlled Trial of Dexmedetomidine Versus Propofol for Sedation in Mechanically Ventilated Medical Intensive Care Unit Patients.
Overview
- Phase
- Phase 4
- Intervention
- Dexmedetomidine
- Conditions
- Mechanical Ventilation
- Sponsor
- University of Chicago
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Proportion of Days With Delirium
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a randomized controlled trial to compare propofol to dexmedetomidine for prolonged sedation (> 24 hours) in critically ill patients who require mechanical ventilation.
Detailed Description
Mechanically ventilated critically ill patients are routinely given sedative and analgesic medications to relieve pain and anxiety associated with intubation, mechanical ventilation, and critical care in general. While integral in minimizing discomfort, these medications may increase mechanical ventilation time, the duration of intensive care unit (ICU) stay, ICU complications (e.g. delirium, ventilator associated pneumonia, venous thromboembolism), the morbidity associated with critical illness, and patient mortality. This study compares two sedative medications that have been used in patients who require a mechanical ventilator. Enrolled patients will be randomly assigned to receive propofol or dexmedetomidine for sedation while they require ventilatory support. All patients will also receive the pain medication fentanyl as needed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\>18 years old
- •mechanically ventilated through endotracheal tube
- •anticipated need for ventilation \> 48 hours
- •requiring sedative/analgesic medication
Exclusion Criteria
- •on mechanical ventilator \> 96 hours
- •primary neurologic disease
- •post cardiac arrest
- •do not speak English (assessment only English language validated)
- •pregnancy or lactation
- •active myocardial ischemia
- •second or third degree heart block
- •pancreatitis
- •elevated serum triglycerides (\> 400 mg/dL)
Arms & Interventions
Dexmedetomidine
Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.
Intervention: Dexmedetomidine
Dexmedetomidine
Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.
Intervention: Fentanyl
Dexmedetomidine
Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.
Intervention: Midazolam
Dexmedetomidine
Patients in this arm will receive continuous dexmedetomidine infusion (0.2 - 1.5 mcg/kg/hour) titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.
Intervention: Physical and Occupational Therapy
Propofol
Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.
Intervention: Propofol
Propofol
Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.
Intervention: Fentanyl
Propofol
Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.
Intervention: Midazolam
Propofol
Patients in this arm will receive propofol (5 - 50 mcg/kg/min) for sedation, titrated to the target Richmond Agitation Sedation Scale for the duration of mechanical ventilation or 7 days on study, whichever is first.
Intervention: Physical and Occupational Therapy
Outcomes
Primary Outcomes
Proportion of Days With Delirium
Time Frame: daily up to 28 days
delirium assessment using CAM-ICU
Secondary Outcomes
- Number of Adverse Medication Effects(duration of infusion of study medication up to 28 days)
- Mortality(28 days from enrollment)
- Number of Participants With ICU Complications(daily through day 28)
- Drug Efficacy According to Richmond Agitation Sedation Scale (RASS) Score(Daily up to day 28)
- Number of Patients Completing Mobility Milestones(Daily through day 28)
- Days on Ventilator(60 days from enrollment)
- Days in ICU(60 days from enollment)
- Number of Patients Requiring Fentanyl(during infusion of study medication up to day 28)
- Days in Hospital(60 days from enrollment)
- Number of Patients Requiring Midazolam(during infusion of study medication through day 28)
- Number of Patients Completing Activities of Daily Living(daily through day 28)