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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02548923
• Other study ID #: UTMCKTRAUMA1
• Status: Completed
• Phase: Phase 4
• First received: August 14, 2015
• Last updated: September 11, 2015
• Start date: November 2014
• Est. completion date: April 2015

Study information

• Verified date: September 2015
• Source: University of Tennessee Graduate School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness
• Delirium

Intervention

Drug:
• Dexmedetomidine
comparison to propofol

Locations

Country	Name	City	State
United States	University of Tennessee Medical Center	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee Graduate School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Mechanical Ventilation	An average of 10 days	ICU stay	No
Secondary	Mortality	An average of 21 days	Hospital length of stay	No
Secondary	proportion of time in target sedation	AN average of 10 days	ICU length of stay	No
Secondary	incidence of delirium	An average of 10 days	ICU length of stay	No
Secondary	hypotension		ICU length of stay	No
Secondary	bradycardia	AN Average of 10 days	ICU length of stay	No
Secondary	ICU and hospital length of stay	An average of 21 days	hospital length of stay	No