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

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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

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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