CompletedPhase 4

Comparison of C-Reactive Protein Levels in Traumatic Brain Injury Patients Undergoing Craniotomy With and Without Dexmedetomidine

Indonesia25 participantsStarted 2025-10-27

Plain-language summary

Traumatic Brain Injury (TBI) is a major cause of morbidity and mortality and is often associated with a systemic inflammatory response after surgery. C-reactive protein (CRP) is a commonly used biomarker to assess inflammation. Dexmedetomidine is an anesthetic adjuvant that may have anti-inflammatory effects. This study aims to compare C-reactive protein levels in traumatic brain injury patients undergoing craniotomy who receive dexmedetomidine with those who do not receive dexmedetomidine. The study is conducted at Prof. Dr. Margono Soekarjo Regional General Hospital, Purwokerto. The results of this study are expected to provide information on the potential effect of dexmedetomidine on postoperative inflammatory response in traumatic brain injury patients.

Who can participate

Age range

18 Years – 60 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: * 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

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

Change in C-Reactive Protein (CRP) Levels

Timeframe: Baseline (Pre-operative), 6 hours and 24 hours post-operative

Trial details

NCT IDNCT07406555

SponsorUniversitas Jenderal Soedirman

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-28

View on ClinicalTrials.gov More Traumatic Brain Injury trials