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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01712477
Recruitment Status : Unknown
Verified October 2012 by Chet Morrison, Michigan State University.
Recruitment status was:  Recruiting
First Posted : October 23, 2012
Last Update Posted : October 23, 2012
Information provided by (Responsible Party):
Chet Morrison, Michigan State University

Brief 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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: Intravenous sedation using propofol Drug: Intravenous sedation with midazolam Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Propofol Versus Midazolam for Sedation in Mechanically Ventilated Critically Ill Patients Who Presented With Traumatic Brain Injury: Cytokine Response and Neuropsychological Assessment (IRRC#1201M)
Study Start Date : November 2011
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Intravenous sedation with propofol
Traumatic brain injured patient, already requiring sedation. Intervention is sedation with intravenous propofol during mechanical ventilation
Drug: Intravenous sedation using propofol
Patients will be given intravenous sedation for treatment of traumatic brain injury requiring mechanical ventilation
Active Comparator: Intravenous sedation with midazolam
Patients with traumatic brain injury requiring mechinical ventilation. Intervention is intravenous midazolam for sedation at variable doses to achieve adequite sedation levels
Drug: Intravenous sedation with midazolam
patients with severe traumatic brain injury requiring mechanical ventilation and sedation will be sedated with midazolam
Other Name: Versed

Primary Outcome Measures :
  1. Neuropsychgologic outcome [ Time Frame: 30 days ]
    Extent of functional deficits from underlying traumatic brain injury

Secondary Outcome Measures :
  1. cytokine levels correlating to extent of injury [ Time Frame: 30 days ]
    cytokine levels will be measured to see if there is meaningful correlation between groups

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ages 18 Years or older
  • Males or Females
  • Primary diagnosis of TBI, subarachnoid hemmorhage (SAH), intracranial hemmorhage (ICH), stroke
  • Requires mechanical ventilation
  • Requires or is receiving continuous IV sedation

Exclusion Criteria:

  • Glascow Coma Score (GCS) of 3 persisting from the scene with bilaterally fixed dilated pupils with no appreciable chance of survival
  • The inability to identify a next of kin or guardian to give consent if patient unable to consent
  • Pregnant
  • Allergy or contraindication to propofol
  • Allergy to contraindication to midalozam
  • Status epilepticus
  • Current neuromuscular blockade
  • Patient with a known hypersensitivity to propofol or midalozam
  • Allergies to eggs, egg products, soybeans or soy products
  • Acute narrow-angle glaucoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01712477

Contact: Chet A Morrison, M.D. 517-267-2465

United States, Michigan
Sparrow Health System Recruiting
Lansing, Michigan, United States, 48912
Principal Investigator: Chet A Morrison, M.D.         
Sponsors and Collaborators
Michigan State University
Principal Investigator: Chet A Morrison, M.D. Michigan State University

Responsible Party: Chet Morrison, Assistant Professor of Surgery, Michigan State University Identifier: NCT01712477     History of Changes
Other Study ID Numbers: r039226
IRRC#1201M ( Other Identifier: Michigan State University IRB )
First Posted: October 23, 2012    Key Record Dates
Last Update Posted: October 23, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action