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

NCT02548923 | Completed Phase 4

• 1 other identifier: UTMCKTRAUMA1
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• Duration of Mechanical Ventilation

  An average of 10 days

  ICU stay

Secondary Outcomes (6)

• Mortality

  Hospital length of stay

• proportion of time in target sedation

  ICU length of stay

• incidence of delirium

  ICU length of stay

• hypotension

  ICU length of stay

• bradycardia

  ICU length of stay

Study Arms (2)

dexmedetomidine group

ACTIVE COMPARATOR

Patients who received dexmedetomidine for sedation

Drug: Dexmedetomidine

propofol group

NO INTERVENTION

Patients who received propofol for sedation

Interventions

Dexmedetomidine DRUG

comparison to propofol

Also known as: Propofol

dexmedetomidine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients were excluded for any of the following:
• 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.

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead

Study Sites (1)

University of Tennessee Medical Center

Knoxville, Tennessee, 37922, United States

Location

MeSH Terms

Conditions

Delirium

Interventions

Dexmedetomidine; Propofol

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: September 14, 2015
• Study Start: November 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 14, 2015

Record last verified: 2015-09

Locations

US (1)