Conditions: Mechanical Ventilation Critical Illness
Keywords: Hypnotics and Sedatives Respiration, Artificial Ventilators, Mechanical Critical care Intensive care Physical therapy Occupational therapy Sedative medications
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 41
Healthy volunteers: no

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.

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Dexmedetomidine intervention 2: Propofol intervention 3: Fentanyl intervention 4: Midazolam intervention 5: Physical and Occupational Therapy
Intervention descriptions: intervention 1: continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS intervention 2: continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS intervention 3: 25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale intervention 4: 0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS\>+2) intervention 5: Daily therapy sessions targeting range of motion, strength, and mobility

Protocol document: