A Comparison of Propofol Versus Midazolam to Sedate Critically Brain Injury; Measurement of Cytokine Response and Assessment of Function
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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) |
- Neuropsychgologic outcome [ Time Frame: 30 days ] [ Designated as safety issue: No ]Extent of functional deficits from underlying traumatic brain injury
- 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 |
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| Contact: Chet A Morrison, M.D. | 517-267-2465 | chet.morrison@hc.msu.edu |
| United States, Michigan | |
| Sparrow Health System | Recruiting |
| Lansing, Michigan, United States, 48912 | |
| Principal Investigator: Chet A Morrison, M.D. | |
| 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 Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries 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 May 16, 2013