A Comparison of Propofol Versus Midazolam to Sedate Critically Brain Injury; Measurement of Cytok… (NCT01712477) | Clinical Trial Compass
TerminatedPhase 4
A Comparison of Propofol Versus Midazolam to Sedate Critically Brain Injury; Measurement of Cytokine Response and Assessment of Function
Stopped: Difficulty in recruiting
United States1 participantsStarted 2011-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.