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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Michigan State University
Sponsor:
Information provided by (Responsible Party):
Chet Morrison, Michigan State University
ClinicalTrials.gov Identifier:
NCT01712477
First received: October 19, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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 Intervention Phase
Traumatic Brain Injury
Drug: Intravenous sedation using propofol
Drug: Intravenous sedation with midazolam
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Michigan State University:

Primary Outcome Measures:
  • Neuropsychgologic outcome [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Extent of functional deficits from underlying traumatic brain injury


Secondary Outcome Measures:
  • cytokine levels correlating to extent of injury [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    cytokine levels will be measured to see if there is meaningful correlation between groups


Estimated Enrollment: 30
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712477

Contacts
Contact: Chet A Morrison, M.D. 517-267-2465 chet.morrison@hc.msu.edu

Locations
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
Investigators
Principal Investigator: Chet A Morrison, M.D. Michigan State University
  More Information

No publications provided

Responsible Party: Chet Morrison, Assistant Professor of Surgery, Michigan State University
ClinicalTrials.gov Identifier: NCT01712477     History of Changes
Other Study ID Numbers: r039226, IRRC#1201M
Study First Received: October 19, 2012
Last Updated: October 19, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014