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Brain injury drug may tame inflammation after surgery

NCT ID NCT07406555

Knowledge-focused Sponsor: Universitas Jenderal Soedirman Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether the sedative dexmedetomidine can lower C-reactive protein (CRP), a marker of inflammation, in 25 adults with traumatic brain injury undergoing emergency or planned skull surgery. Patients received either dexmedetomidine or a standard sedative during surgery. The goal was to see if dexmedetomidine could dampen the body's inflammatory response after the operation.

What this could mean

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

Active substance
Dexmedetomidine
What this could lead to
If it works, this could point toward using dexmedetomidine to reduce harmful inflammation after brain surgery, potentially improving recovery.
What could go wrong
This is a very small, single-hospital study (25 people) looking only at a blood marker, not patient outcomes. Results may not apply broadly or lead to a treatment.

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

25 people

The number who actually took part.

Started

Oct 2025

Finished

Nov 2025

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 60 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: * Patients aged ≥ 18 years to ≤ 60 years * Patients with secondary brain injury with onset ≥ 6 hours * Patients with a GCS score \> 6 undergoing emergency and elective craniotomy * American Society of Anesthesiologists (ASA) physical status ≥ II * Body mass index \> 17 kg/m² and \< 30 kg/m² Exclusion Criteria: * Patients with head injury onset \< 6 hours * Patients with signs of systemic shock * Patients or family members who refuse to participate * Patients with a history of allergy to dexmedetomidine, sevoflurane, and/or sufentanil * Patients with a history of active infection or sepsis * Patients who have received massive blood transfusion prior to surgery * Patients with autoimmune diseases * Patients with active malignancy * Patients with a history of chemotherapy * Patients with a history of hepatic dysfunction, indicated by elevated alanine aminotransferase (ALT/SGPT) levels above the normal reference range (7-56 U/L) * Patients with a history of long-term corticosteroid therapy * Patients with a history of neuropsychiatric disorders and cognitive impairment * Patients with a history of pre-existing cardiovascular disease * Patients with a history of coagulation disorders

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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 injury

Contacts and locations

Locations

  • RSUD Prof. Dr. Margono Soekarjo

    Purwokerto, Central Java, Indonesia

More trials for these conditions

Other studies related to the condition(s) this trial covers.