Comparing Sedatives for Intracranial Pressure Control in Traumatic Brain Injury (NCT07678216) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparing Sedatives for Intracranial Pressure Control in Traumatic Brain Injury
Egypt210 participantsStarted 2026-07-01
Plain-language summary
The goal of this clinical trial is to compare the effects of propofol, midazolam, and dexmedetomidine on intracranial pressure control and clinical outcomes in adults with moderate-to-severe traumatic brain injury undergoing urgent neurosurgical intervention.
The main questions it aims to answer are:
* Which sedative agent provides better control of intracranial pressure, assessed by optic nerve sheath diameter (ONSD), during the first 24 hours after neurosurgical intervention?
* How do the three sedative agents compare in achieving target sedation depth, maintaining hemodynamic stability, and improving short-term clinical outcomes such as ICU mortality, duration of mechanical ventilation, and ICU length of stay?
Participants will be randomly assigned to receive propofol, midazolam, or dexmedetomidine for 24 hours of continuous sedation. Clinical, hemodynamic, and neurological outcomes will be assessed and compared among the three study groups.
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:
* Age ≥18 years
* Moderate to severe traumatic brain injury with post-resuscitation Glasgow Coma Scale (GCS) ≤12
* Undergone urgent neurosurgical intervention (craniotomy, craniectomy, or ICP monitor placement) within 24 hours of injury
* Admitted to ICU and expected to require continuous sedation
* Hemodynamically stable or stabilized (defined as MAP ≥65 mmHg with vasopressor requirement ≤0.1 mcg/kg/min norepinephrine equivalent)
* Informed consent obtained from legally authorized representative
Exclusion Criteria:
* The Relative refusal to participate in the research.
* Known allergy or contraindication to propofol, midazolam, or dexmedetomidine
* Pre-existing neurological disorders (epilepsy, prior stroke, brain tumors, dementia) that may interfere with outcome assessment
* Severe hepatic dysfunction (Child-Pugh Class C) or acute liver failure
* Severe renal dysfunction (eGFR \<30 mL/min/1.73m² or requiring renal replacement therapy)
* Pregnancy or breastfeeding
* Hemodynamic instability requiring norepinephrine \>0.1 mcg/kg/min or equivalent vasopressor support
* Heart rate \<50 bpm or second/third-degree AV block without pacemaker (relative contraindication for dexmedetomidine)
* Clinical determination of brain death or expected survival \<24 hours
* Enrollment in another interventional trial
* Severe polytrauma requiring ongoing surgical interventions that would interfere with protocol adherence
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.
What they're measuring
1
Intracranial Pressure Control Assessed by Optic Nerve Sheath Diameter (ONSD)
Timeframe: Baseline, 6 hours, 12 hours, and 24 hours after initiation of sedation