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

Phase 4

Completed

• Conditions: Delirium
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT02548923
• Lead Sponsor: University of Tennessee Graduate School of Medicine

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Study First Submitted: 2015-08-14
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-11
• Last Update Submitted: 2015-09-11
• Study First Posted: 2015-09-14
• Last Update Posted: 2015-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine group	Dexmedetomidine	Patients who received dexmedetomidine for sedation

Primary Outcome Measures

Name	Time	Method
Duration of Mechanical Ventilation	ICU stay	An average of 10 days

Secondary Outcome Measures

Name	Time	Method
Mortality	Hospital length of stay	An average of 21 days
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
hypotension	ICU length of stay
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

Trial Locations

Locations (1)

University of Tennessee Medical Center; 🇺🇸 Knoxville, Tennessee, United States