Skip to main content
OpenTrials
Completed

NCT Number: NCT02548923

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Tennessee Medical Center

Knoxville, Tennessee, 37922, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

comparison to propofol

Other names: Propofol

Primary outcomes

  1. Duration of Mechanical Ventilation

    Time frame: ICU stay

    An average of 10 days

Secondary outcomes

  1. Mortality

    Time frame: Hospital length of stay

    An average of 21 days

  2. proportion of time in target sedation

    Time frame: ICU length of stay

    AN average of 10 days

  3. incidence of delirium

    Time frame: ICU length of stay

    An average of 10 days

  4. hypotension

    Time frame: ICU length of stay

  5. bradycardia

    Time frame: ICU length of stay

    AN Average of 10 days

  6. ICU and hospital length of stay

    Time frame: hospital length of stay

    An average of 21 days

Sponsors and collaborators

Lead sponsor

University of Tennessee Graduate School of Medicine

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 14, 2015
Registry last updated
Sep 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.