Back to resultsDexmedetomidine Versus Propofol for Prolonged Sedation in Critically Ill Trauma and Surgical Patients
Primary Purpose
Delirium
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
About this trial
This is an interventional prevention trial for Delirium
Eligibility Criteria
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.
Sites / Locations
- University of Tennessee Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
dexmedetomidine group
propofol group
Arm Description
Patients who received dexmedetomidine for sedation
Patients who received propofol for sedation
Outcomes
Primary Outcome Measures
Duration of Mechanical Ventilation
An average of 10 days
Secondary Outcome Measures
Mortality
An average of 21 days
proportion of time in target sedation
AN average of 10 days
incidence of delirium
An average of 10 days
hypotension
bradycardia
AN Average of 10 days
ICU and hospital length of stay
An average of 21 days
Full Information
NCT ID
NCT02548923
First Posted
August 14, 2015
Last Updated
September 11, 2015
Sponsor
University of Tennessee Graduate School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02548923
Brief Title
Dexmedetomidine Versus Propofol for Prolonged Sedation in Critically Ill Trauma and Surgical Patients
Official Title
Dexmedetomidine Versus Propofol for Prolonged Sedation in Critically Ill Trauma and Surgical Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tennessee Graduate School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dexmedetomidine group
Arm Type
Active Comparator
Arm Description
Patients who received dexmedetomidine for sedation
Arm Title
propofol group
Arm Type
No Intervention
Arm Description
Patients who received propofol for sedation
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Propofol
Intervention Description
comparison to propofol
Primary Outcome Measure Information:
Title
Duration of Mechanical Ventilation
Description
An average of 10 days
Time Frame
ICU stay
Secondary Outcome Measure Information:
Title
Mortality
Description
An average of 21 days
Time Frame
Hospital length of stay
Title
proportion of time in target sedation
Description
AN average of 10 days
Time Frame
ICU length of stay
Title
incidence of delirium
Description
An average of 10 days
Time Frame
ICU length of stay
Title
hypotension
Time Frame
ICU length of stay
Title
bradycardia
Description
AN Average of 10 days
Time Frame
ICU length of stay
Title
ICU and hospital length of stay
Description
An average of 21 days
Time Frame
hospital length of stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dexmedetomidine Versus Propofol for Prolonged Sedation in Critically Ill Trauma and Surgical Patients
We'll reach out to this number within 24 hrs