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

NCT07406555 | Completed Phase 4

• 1 other identifier: 146/KEPK/PE/XII/2025
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Brain Injury

Keywords

Dexmedetomidine; C-Reactive Protein; Craniotomy

Outcome Measures

Primary Outcomes (1)

• Change in C-Reactive Protein (CRP) Levels

  Serum CRP levels measured to assess the inflammatory response

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

Study Arms (2)

Dexmedetomidine Group

EXPERIMENTAL

Patients undergoing craniotomy for traumatic brain injury who receive Dexmedetomidine administration.

Drug: Dexmedetomidine

control

ACTIVE COMPARATOR

Patients undergoing craniotomy for traumatic brain injury receiving Sufentanyl as the standard analgesic/sedative agent.

Drug: Sufentanyl

Interventions

Dexmedetomidine DRUG

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

Dexmedetomidine Group

Sufentanyl DRUG

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

control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Jenderal Soedirman: lead

Study Sites (1)

RSUD Prof. Dr. Margono Soekarjo

Purwokerto, Central Java, Indonesia

Location

Related Publications (33)

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Dexmedetomidine; Sufentanil

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl; Piperidines

Study Officials

• Adrian Nugraha Putra

  Universitas Jenderal Soedirman

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: A parallel-group interventional study to compare the effect of Dexmedetomidine administration on C-Reactive Protein (CRP) levels in traumatic brain injury patients undergoing craniotomy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A parallel-group interventional study comparing C-Reactive Protein (CRP) levels between patients receiving intravenous Dexmedetomidine and a control group (standard care) during craniotomy for traumatic brain injury

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start: October 27, 2025
• Primary Completion: October 28, 2025
• Study Completion: November 24, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)