Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU)

The University of Chicago

Status and phase: Terminated; Phase 4

Conditions: Critical Illness; Mechanical Ventilation

Treatments: Behavioral: Physical and Occupational Therapy; Drug: Propofol; Drug: Fentanyl; Drug: Midazolam; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01059929

16865B

Details and patient eligibility

About

This is a randomized controlled trial to compare propofol to dexmedetomidine for prolonged sedation (> 24 hours) in critically ill patients who require mechanical ventilation.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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41 participants in 2 patient groups

Dexmedetomidine

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Drug: Fentanyl

Drug: Midazolam

Behavioral: Physical and Occupational Therapy

Propofol

Active Comparator group

Description:

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.

Treatment:

Drug: Fentanyl

Drug: Midazolam

Drug: Propofol

Behavioral: Physical and Occupational Therapy