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

U

University of Tennessee Graduate School of Medicine

Status and phase

Completed
Phase 4

Conditions

Delirium

Treatments

Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT02548923
UTMCKTRAUMA1

Details and patient eligibility

About

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

Full 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.

Enrollment

57 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

57 participants in 2 patient groups

dexmedetomidine group
Active Comparator group
Description:
Patients who received dexmedetomidine for sedation
Treatment:
Drug: Dexmedetomidine
propofol group
No Intervention group
Description:
Patients who received propofol for sedation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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