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A Comparison of Propofol Versus Midazolam to Sedate Critically Brain Injury; Measurement of Cytokine Response and Assessment of Function

NCT01712477 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-09-10

Study results available
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Summary

This is a prospective randomized controlled pilot study in traumatic brain injury (TBI) patients who are sedated with either propofol or midazolam to compare the cytokine response and neuropsychological outcomes with and without elevated blood alcohol levels.

Sedation is part of the standard treatment in patients with a TBI and has been proposed as a neuroprotective intervention in head-injured patients. Sedative regimens, such as midazolam and propofol, are not standardized and it is unclear whether sedation has a significant impact on recovery and outcome. A review of propofol versus midazolam in mechanically ventilated patients shows evidence that both provide effective sedation but there is lack of data to support one sedative over the other.

Cytokines are released in response to tissue injury and act to generate a variety of physiologic responses. The cytokine elevation has been correlated with the extent of tissue injury. This study will compare the cytokine distribution patterns at specific posttraumatic time points in patients with a TBI sedated with either propofol or midazolam. Additional analysis will compare the cytokine response in patients whom had elevated blood alcohol levels with those with normal levels. Neuropsychological testing will also be performed to determine the extent of brain injury and recovery.

Conditions

Interventions

DRUG

Intravenous sedation using propofol

Patients will be given intravenous sedation for treatment of traumatic brain injury requiring mechanical ventilation

DRUG

Intravenous sedation with midazolam

patients with severe traumatic brain injury requiring mechanical ventilation and sedation will be sedated with midazolam

Sponsors & Collaborators

Principal Investigators

  • Chet A Morrison, M.D. · Michigan State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-11-30
Completion
2014-12-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01712477 on ClinicalTrials.gov