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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-04-30

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.

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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.

Conditions

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Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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dexmedetomidine group

Patients who received dexmedetomidine for sedation

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

comparison to propofol

propofol group

Patients who received propofol for sedation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dexmedetomidine

comparison to propofol

Intervention Type DRUG

Other Intervention Names

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Propofol

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes