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.

Study Overview

• Status: Completed
• Conditions: Delirium
• Intervention / Treatment: Drug: Dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • University of Tennessee Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: dexmedetomidine group; Patients who received dexmedetomidine for sedation	Drug: Dexmedetomidine; comparison to propofol; Other Names: Propofol
No Intervention: propofol group; Patients who received propofol for sedation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Tennessee Graduate School of Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: August 14, 2015
• First Submitted That Met QC Criteria: September 11, 2015
• First Posted (Estimate): September 14, 2015

Study Record Updates

• Last Update Posted (Estimate): September 14, 2015
• Last Update Submitted That Met QC Criteria: September 11, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Disease Attributes; Delirium; Critical Illness; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: UTMCKTRAUMA1