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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02548923

Enrollment

Registered

2015-09-14

Start date

2014-11-30

Completion date

2015-04-30

Last updated

2015-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Brief summary

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

Detailed description

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.

Interventions

DRUGDexmedetomidine

comparison to propofol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Duration of Mechanical Ventilation	ICU stay	An average of 10 days

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026