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

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

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Sufentanyl

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • Central Java
    • Purwokerto, Central Java, Indonesia
      • RSUD Prof. Dr. Margono Soekarjo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine Group; Patients undergoing craniotomy for traumatic brain injury who receive Dexmedetomidine administration.	Drug: Dexmedetomidine; Intravenous administration of Dexmedetomidine to evaluate its effect on inflammatory markers (CRP)
Active Comparator: control; Patients undergoing craniotomy for traumatic brain injury receiving Sufentanyl as the standard analgesic/sedative agent.	Drug: Sufentanyl; Intravenous administration of Sufentanyl as an active comparator in the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitas Jenderal Soedirman
• Investigators: Principal Investigator: Adrian Nugraha Putra, Universitas Jenderal Soedirman

Publications and helpful links

General Publications

• Zhao, Y. et al. (2020) 'Mechanisms of Dexmedetomidine in Neuropathic Pain', Frontiers in Neuroscience. Frontiers Media S.A. Available at: https://doi.org/10.3389/fnins.2020.00330
• Xu, J. and Xiao, Q. (2022) 'Assessment of the effects of dexmedetomidine on outcomes of traumatic brain injury using propensity score analysis', BMC Anesthesiology, 22(1). Available at: https://doi.org/10.1186/s12871-022-01822-2.
• Wiles, M.D. (2022) 'Management of traumatic brain injury: a narrative review of current evidence', Anaesthesia. John Wiley and Sons Inc, pp. 102-112. Available at: https://doi.org/10.1111/anae.15608
• Weerink, M.A.S. et al. (2017) 'Clinical Pharmacokinetics and Pharmacodynamics of Dexmedetomidine', Clinical Pharmacokinetics, 56(8), pp. 893-913. Available at: https://doi.org/10.1007/s40262-017-0507-7
• Vitali, M. et al. (2023) 'Decompressive Craniectomy in Severe Traumatic Brain Injury: The Intensivist's Point of View', Diseases, 11(1). Available at: https://doi.org/10.3390/diseases11010022
• Thapa, K. et al. (2021) 'Traumatic Brain Injury: Mechanistic Insight on Pathophysiology and Potential Therapeutic Targets', Journal of Molecular Neuroscience, 71(9), pp. 1725-1742. Available at: https://doi.org/10.1007/s12031-021-01841-7
• Slupe, A.M. and Kirsch, J.R. (2018) 'Effects of anesthesia on cerebral blood flow, metabolism, and neuroprotection', Journal of Cerebral Blood Flow and Metabolism, 38(12), pp. 2192-2208. Available at: https://doi.org/10.1177/0271678X18789273
• Sakti, S., Kriswidyatomo, P. and Sumartono, C. (2025) 'The Effect of Dexmedetomidine on Post-Operative C-Reactive Protein Levels in Patients Undergoing Brain Tumor Resection: A Literature Review', Vascular and Endovascular Review, 8. Available at: www.VERjournal.com
• Randall, Z.D. et al. (2022) 'Demographic, behavioral, dietary, and clinical predictors of high-sensitivity C-reactive protein: The National Health and Nutrition Examination Surveys (NHANES)', American Heart Journal Plus: Cardiology Research and Practice, 21. Available at: https://doi.org/10.1016/j.ahjo.2022.100196
• Ng, S.Y. and Lee, A.Y.W. (2019) 'Traumatic Brain Injuries: Pathophysiology and Potential Therapeutic Targets', Frontiers in Cellular Neuroscience, 13. Available at: https://doi.org/10.3389/fncel.2019.00528
• Murdoch, I., Surda, P. and Nguyen-Lu, N. (2021) 'Anaesthesia for rhinological surgery', BJA Education, 21(6), pp. 225-231. Available at: https://doi.org/10.1016/j.bjae.2021.02.004
• Liu, X. et al. (2021) 'Recent Advances in the Clinical Value and Potential of Dexmedetomidine', Journal of Inflammation Research, 14, pp. 7507-7527. Available at: https://doi.org/10.2147/JIR.S346089
• Li, Y. et al. (2015) 'Effect of dexmedetomidine on early postoperative cognitive dysfunction and peri-operative inflammation in elderly patients undergoing laparoscopic cholecystectomy', Experimental and Therapeutic Medicine, 10(5), pp. 1635-1642. Available at: https://doi.org/10.3892/etm.2015.2726
• Kim, H. (2023) 'Anesthetic management of the traumatic brain injury patients undergoing non-neurosurgery', Anesthesia and Pain Medicine, 18(2), pp. 104-113. Available at: https://doi.org/10.17085/apm.23017
• Huang, Y. et al. (2022) 'Comparing the Effect of Dexmedetomidine and Midazolam in Patients with Brain Injury', Brain Sciences, 12(6). Available at: https://doi.org/10.3390/brainsci12060752
• Huang, C.Y. et al. (2024) 'Assessing the Predictive Utility of the C-Reactive Protein-to-Lymphocyte Ratio for Mortality in Isolated Traumatic Brain Injury: A Single-Center Retrospective Analysis', Diagnostics, 14(18). Available at: https://doi.org/10.3390/diagnostics14182065
• Hu, Y. et al. (2022) 'The neuroprotective effect of dexmedetomidine and its mechanism', Frontiers in Pharmacology, 13(September), pp. 1-15. Available at: https://doi.org/10.3389/fphar.2022.965661
• Hosseininejad, S.M. et al. (2023) 'C-Reactive Protein and D-Dimer as Prognostic Markers for Clinical Outcomes in Patients with Mild Traumatic Brain Injury: A Cross-Sectional Study', Journal compilation © 2023 Trauma Research Center, Shiraz University of Medical Sciences Hosseininejad SM et al. Bull Emerg Trauma, 11(3), pp. 119-124. Available at: https://doi.org/10.30476/BEAT.2023.98573.1435
• Hatfield, J. et al. (2024) 'Safety, Efficacy, and Clinical Outcomes of Dexmedetomidine for Sedation in Traumatic Brain Injury: A Scoping Review', Journal of Neurosurgical Anesthesiology, 36(2), pp. 101-108. Available at: https://doi.org/10.1097/ANA.0000000000000907
• Haarbauer-Krupa, J. et al. (2021) 'Epidemiology of Chronic Effects of Traumatic Brain Injury', Journal of Neurotrauma, 38(23), pp. 3235-3247. Available at: https://doi.org/10.1089/neu.2021.0062
• Feng, X. et al. (2021) 'Dexmedetomidine alleviates early brain injury following traumatic brain injury by inhibiting autophagy and neuroinflammation through the ROS/Nrf2 signaling pathway', Molecular Medicine Reports, 24(3). Available at: https://doi.org/10.3892/mmr.2021.12300
• Ding, M. et al. (2019) 'Dexmedetomidine reduces inflammation in traumatic brain injury by regulating the inflammatory responses of macrophages and splenocytes', Experimental and Therapeutic Medicine [Preprint]. Available at: https://doi.org/10.3892/etm.2019.7790
• Dewan, M.C. et al. (2019) 'Estimating the global incidence of traumatic brain injury', Journal of Neurosurgery, 130(4), pp. 1080-1097. Available at: https://doi.org/10.3171/2017.10.JNS17352
• Department of Nutrition for Health and Development World Health Organization. (2014) C-reactive protein concentrations as a marker of inflammation or infection for interpreting biomarkers of micronutrient status, Geneva. Available at: http://apps.who.int/iris/bitstream/10665/133708/1/WHO
• Dahlan, M.S. (2019) Besar Sampel dalam Penelitian Kedokteran dan Kesehatan. Jakarta: Epidemiologi Indonesia.
• Crowe, G., Atterton, B. and Moran, L. (2022) 'Perioperative Applications of Dexmedetomidine', Anaesthesia Tutorial of The Week [Preprint]. Available at: https://resources.wfsahq.org/anaesthesia-tutorial-of-the-week/.
• Chen, R. et al. (2021) 'The Anti-inflammatory Effect of Dexmedetomidine Administration on Patients Undergoing Intestinal Surgery: A Randomized Study', Drugs in R and D, 21(4), pp. 445-453. Available at: https://doi.org/10.1007/s40268-021-00368-x.
• Brodier, E.A. and Cibelli, M. (2021) 'Postoperative cognitive dysfunction in clinical practice', BJA Education. Elsevier Ltd, pp. 75-82. Available at: https://doi.org/10.1016/j.bjae.2020.10.004
• Bastian, B., Sari, I. and Pratama, F.P. (2022) 'Analysis of C-Reactive Protein (CRP) Levels in Venous and Capillary Blood Samples with Immunoturbidimetric Methods', Medicra (Journal of Medical Laboratory Science/Technology), 5(1), pp. 1-5. Available at: https://doi.org/10.21070/medicra.v5i1.1622.
• Bafna, U. et al. (2021) 'Comparison of hypotensive properties of dexmedetomidine versus clonidine for induced hypotension during functional endoscopic sinus surgery: A randomised, double-blind interventional study', Indian Journal of Anaesthesia, 65(8), pp. 579-585. Available at: https://doi.org/10.4103/ija.IJA_57_21.
• Ayala J, Smith A, F.D. (2006) 'C-reactive protein levels following cardiac surgery in adults', European Journal of Anaesthesiology | EJA, 23, p. 758.
• Ali, S. et al. (2023) 'Role of C-reactive protein in disease progression, diagnosis and management', Discoveries, 11(4), p. e179. Available at: https://doi.org/10.15190/d.2023.18.
• Akashi, N. et al. (2021) 'Cardiovascular and renal effects of constant rate infusions of remifentanil, dexmedetomidine and their combination in dogs anesthetized with sevoflurane', Journal of Veterinary Medical Science, 83(2), pp. 285-296. Available at: https://doi.org/10.1292/jvms.20-0457.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2025
• Primary Completion (Actual): October 28, 2025
• Study Completion (Actual): November 24, 2025

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: C-Reactive Protein; Dexmedetomidine; Craniotomy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Piperidines; Fentanyl; Dexmedetomidine; Sufentanil
• Other Study ID Numbers: 146/KEPK/PE/XII/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No