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

Phase 4TerminatedNCT01059929

University of Chicago41 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Mechanical Ventilation Critical Illness

Interventions

DexmedetomidineDRUG

continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS

PropofolDRUG

continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS

FentanylDRUG

25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

The University of Chicago Medical Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Proportion of Days With Delirium

delirium assessment using CAM-ICU

Time frame: daily up to 28 days

Secondary Outcomes

Drug Efficacy According to Richmond Agitation Sedation Scale (RASS) Score

Richmond Agitation Sedation Scale (RASS). This is a validated scale that measures level of sedation. The scale ranges from -5 to +4. -5 refers to a state where one is unarousable, +4 refers to a state where one is combative. The median and inter-quartile range over all daily assessments will be provided.

Time frame: Daily up to day 28

Number of Patients Completing Mobility Milestones

Milestones: sitting upright independently, standing independently, transfer to chair, marching in place, ambulating independently

Time frame: Daily through day 28

Days on Ventilator

Time frame: 60 days from enrollment

Days in ICU

Time frame: 60 days from enollment

Mortality

Time frame: 28 days from enrollment

Number of Participants With ICU Complications

Time frame: daily through day 28

Number of Patients Requiring Fentanyl

Time frame: during infusion of study medication up to day 28

Number of Patients Requiring Midazolam

Time frame: during infusion of study medication through day 28

Data from ClinicalTrials.gov

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