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Can a common sedative shield the brain after injury?

NCT ID NCT07807579

Disease control Sponsor: Assiut University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This trial tests whether dexmedetomidine or propofol, two sedatives used in intensive care, better controls pressure inside the skull after a traumatic brain injury. Researchers will measure pressure indirectly using ultrasound of the optic nerve sheath and check blood levels of a marker of oxidative stress. The study includes adults aged 18 to 65 with moderate to severe brain injury who need breathing support and sedation for more than a day. The goal is to see which drug offers stronger neuroprotection, not just sedation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dexmedetomidine and propofol
What this could lead to
If one drug proves better at controlling brain pressure and reducing oxidative damage, it could become the preferred sedative for traumatic brain injury patients, potentially improving recovery outcomes.
What could go wrong
This is a single-center trial with 80 participants, so results may not apply broadly. The study measures indirect markers like optic nerve sheath diameter and blood MDA levels, which may not fully reflect actual brain protection.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients aged between 18 and 65 years. 2. Both genders. 3. Moderate to severe traumatic brain injury with Glasgow coma scale scores between 4 and 12 on admission, with no need for surgical operations. 4. Requiring mechanical ventilation and continuous sedation for more than 24 hours. Exclusion Criteria: 1. History of severe hepatic or renal failure. 2. Known hypersensitivity to propofol or dexmedetomidine. 3. Pre-existing severe bradycardia (heart rate less than 50 bpm) or advanced heart block. 4. Confirmed brain death or moribund patients. 5. Pregnancy or lactation. 6. Preexisting neurological disease affecting GCS interpretation. 7. General anesthesia 24 hours prior to or planned after the start of study drug infusion. 8. Serious central nervous system pathology (acute stroke, severe dementia, uncontrolled seizures). 9. Patients with compromised cardiac diseases or heart block. 10. Any patients with ocular trauma, orbital fractures, glaucoma, or history of optic nerve disease.

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Traumatic brain injuries

How to take part

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  1. 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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  2. A doctor treating you

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