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NCT Number: NCT07406555

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

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

RSUD Prof. Dr. Margono Soekarjo

Purwokerto, Central Java, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Intravenous administration of Dexmedetomidine to evaluate its effect on inflammatory markers (CRP)

Sufentanyl

Drug

Intravenous administration of Sufentanyl as an active comparator in the control group

Primary outcomes

  1. Change in C-Reactive Protein (CRP) Levels

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

    Serum CRP levels measured to assess the inflammatory response

Sponsors and collaborators

Lead sponsor

Universitas Jenderal Soedirman

Other

Registry information

Official study title

Differences in C-Reactive Protein Levels Between Traumatic Brain Injury Patients Receiving Dexmedetomidine and Those Not Receiving Dexmedetomidine Undergoing Craniotomy at Prof. Dr. Margono Soekarjo Regional General Hospital, Purwokerto

Acronym: DEX-CRP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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