Which sedative best protects the brain after injury? trial pits three common drugs Head-to-Head
NCT ID NCT07678216
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This trial compares three sedatives—propofol, midazolam, and dexmedetomidine—for controlling pressure inside the skull after urgent brain surgery for moderate-to-severe traumatic brain injury. Adults who have had surgery within 24 hours of injury will receive one of the three drugs for 24 hours. The study measures how well each drug controls brain pressure, how deeply it sedates, and how it affects ICU outcomes like time on a ventilator and survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- propofol, midazolam, dexmedetomidine
- What this could lead to
- If one sedative proves better at controlling brain pressure, it could improve recovery and reduce ICU time for people with traumatic brain injury.
- What could go wrong
- This is a single-center trial with 210 participants, so results may not apply to all patients. The study only looks at 24 hours of sedation, not long-term outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 210 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aswan University Hospital
Asyut, Asyut Governorate, 81528, Egypt
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