Dexmedetomidine Versus Propofol for Prolonged Sedation in Critically Ill Trauma and Surgical Patients

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of dexmedetomidine versus propofol for prolonged sedation in trauma and surgical patients.

Detailed Description
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Design: Open-label, single-center prospective study. Setting: Trauma/Surgical Intensive Care Unit (TSICU) at a Level I academic trauma center. Patients: Patients 18 years of age or older requiring mechanical ventilation and admitted to the TSICU Interventions: Patients were randomly assigned based on unit bed location to receive dexmedetomidine or propofol for sedation.

Official Title
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Dexmedetomidine Versus Propofol for Prolonged Sedation in Critically Ill Trauma and Surgical Patients

Conditions
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Delirium

Intervention / Treatment
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* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were included in the study if they were 18 years of age or older, mechanically ventilated, placed on the institutional sedation protocol, expected to require sedation lasting 24 hours after randomization, and admitted to the TSICU and followed by the Trauma/Surgical Service. Exclusion Criteria: Patients were excluded for any of the following: 72 hours or greater since sedation protocol initiation, treatment per the institutional traumatic brain injury (TBI) protocol, concomitant continuous infusion of a neuromuscular blocking agent, heart rate less than 50 beats per minute, mean arterial pressure less than 55 mmHg despite fluid resuscitation and vasopressors, and use of other alpha-2 agonists within 24 hours of randomization.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexmedetomidine group<br>Patients who received dexmedetomidine for sedation | Drug: Dexmedetomidine<br>* comparison to propofol<br>* Other names: Propofol;|
| No Intervention: propofol group<br>Patients who received propofol for sedation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Mechanical Ventilation | An average of 10 days | ICU stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | An average of 21 days | Hospital length of stay | 
| proportion of time in target sedation | AN average of 10 days | ICU length of stay | 
| incidence of delirium | An average of 10 days | ICU length of stay | 
| hypotension |  | ICU length of stay | 
| bradycardia | AN Average of 10 days | ICU length of stay | 
| ICU and hospital length of stay | An average of 21 days | hospital length of stay |