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

NCT01712477 | Terminated Phase 4 Results

• 2 other identifiers: r039226IRRC#1201M
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Neuropsychologic Outcome

  Extent of functional deficits from underlying traumatic brain injury

  30 days

Secondary Outcomes (1)

• Cytokine Levels Correlating to Extent of Injury

  30 days

Study Arms (2)

Intravenous sedation with propofol

ACTIVE COMPARATOR

Traumatic brain injured patient, already requiring sedation. Intervention is sedation with intravenous propofol during mechanical ventilation

Drug: Intravenous sedation using propofol

Intravenous sedation with midazolam

ACTIVE COMPARATOR

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

Interventions

Intravenous sedation using propofol DRUG

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

Intravenous sedation with propofol

Intravenous sedation with midazolam DRUG

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

Also known as: Versed

Intravenous sedation with midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (1)

Sparrow Health System

Lansing, Michigan, 48912, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chet A Morrison, M.D.
• Organization: Michigan State University

chet.morrison@cmich.edu

9897901001

Study Officials

• Chet A Morrison, M.D.

  Michigan State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2012
• First Posted: October 23, 2012
• Study Start: November 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 10, 2025
• Results First Posted: June 26, 2025

Record last verified: 2020-09

Locations

US (1)