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

Universitas Jenderal Soedirman

Status and phase

Completed

Phase 4

Conditions

Traumatic Brain Injury

Treatments

Drug: Dexmedetomidine

Drug: Sufentanyl

Study type

Interventional

Funder types

Other

Identifiers

NCT07406555

146/KEPK/PE/XII/2025

Details and patient eligibility

About

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.

Full description

This study is an interventional study conducted in traumatic brain injury patients undergoing craniotomy at Prof. Dr. Margono Soekarjo Regional General Hospital, Purwokerto. Eligible patients are divided into two groups: patients who receive dexmedetomidine as part of perioperative management and patients who do not receive dexmedetomidine.

C-reactive protein levels are measured as an indicator of systemic inflammatory response. The primary objective of the study is to compare CRP levels between the two groups. Data are collected from medical records and laboratory examinations and analyzed to evaluate differences in inflammatory response between patients receiving dexmedetomidine and those not receiving dexmedetomidine.

Enrollment

25 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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