AzTrials
AzTrials

Traumatic Brain InjuryPhase 4DEX-CRPNCT07406555

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

A Phase 4 study testing Dexmedetomidine and Sufentanyl in people with Traumatic Brain Injury, run by Universitas Jenderal Soedirman at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Traumatic Brain Injury
What is being tested?
Dexmedetomidine and Sufentanyl
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteIndonesia
Study dates
27 Oct 2025to 24 Nov 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • RSUD Prof. Dr. Margono Soekarjo

    Purwokerto, Central Java

Other trials in Indonesia

About this study

Official 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

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.

Read the 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.

Being tested
Dexmedetomidine, Sufentanyl
Keywords
Dexmedetomidine, C-Reactive Protein, Craniotomy
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

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

  • SufentanylDrug

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

Study groups in NCT07406555
Study groupRoleWhat they receive
Dexmedetomidine GroupExperimentalPatients undergoing craniotomy for traumatic brain injury who receive Dexmedetomidine administration.
Receives: Drug: Dexmedetomidine
controlActive comparatorPatients undergoing craniotomy for traumatic brain injury receiving Sufentanyl as the standard analgesic/sedative agent.
Receives: Drug: Sufentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Serum CRP levels measured to assess the inflammatory response

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2026
  2. Study start27 Oct 2025
  3. Primary completion28 Oct 2025
  4. Study completion24 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07406555
Sponsor's protocol ID
146/KEPK/PE/XII/2025
Acronym
DEX-CRP
Status last verified
Feb 2026
First submitted
5 Feb 2026
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhao Y, He J, Yu N, Jia C, Wang S. Mechanisms of Dexmedetomidine in Neuropathic Pain. Front Neurosci. 2020 May 5;14:330. doi: 10.3389/fnins.2020.00330. eCollection 2020.

    PubMed 32431587

  • Xu J, Xiao Q. Assessment of the effects of dexmedetomidine on outcomes of traumatic brain injury using propensity score analysis. BMC Anesthesiol. 2022 Sep 2;22(1):280. doi: 10.1186/s12871-022-01822-2.

    PubMed 36056318

  • Wiles MD. Management of traumatic brain injury: a narrative review of current evidence. Anaesthesia. 2022 Jan;77 Suppl 1:102-112. doi: 10.1111/anae.15608.

    PubMed 35001375

  • Weerink MAS, Struys MMRF, Hannivoort LN, Barends CRM, Absalom AR, Colin P. Clinical Pharmacokinetics and Pharmacodynamics of Dexmedetomidine. Clin Pharmacokinet. 2017 Aug;56(8):893-913. doi: 10.1007/s40262-017-0507-7.

    PubMed 28105598

  • Vitali M, Marasco S, Romenskaya T, Elia A, Longhitano Y, Zanza C, Abenavoli L, Scarpellini E, Bertuccio A, Barbanera A. Decompressive Craniectomy in Severe Traumatic Brain Injury: The Intensivist's Point of View. Diseases. 2023 Jan 30;11(1):22. doi: 10.3390/diseases11010022.

    PubMed 36810536

  • Thapa K, Khan H, Singh TG, Kaur A. Traumatic Brain Injury: Mechanistic Insight on Pathophysiology and Potential Therapeutic Targets. J Mol Neurosci. 2021 Sep;71(9):1725-1742. doi: 10.1007/s12031-021-01841-7. Epub 2021 May 6.

    PubMed 33956297

  • Slupe AM, Kirsch JR. Effects of anesthesia on cerebral blood flow, metabolism, and neuroprotection. J Cereb Blood Flow Metab. 2018 Dec;38(12):2192-2208. doi: 10.1177/0271678X18789273. Epub 2018 Jul 16.

    PubMed 30009645

  • 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 ZD, Brouillard AM, Deych E, Rich MW. Demographic, behavioral, dietary, and clinical predictors of high-sensitivity C-reactive protein: The National Health and Nutrition Examination Surveys (NHANES). Am Heart J Plus. 2022 Aug 27;21:100196. doi: 10.1016/j.ahjo.2022.100196. eCollection 2022 Sep.

    PubMed 38559751

  • Ng SY, Lee AYW. Traumatic Brain Injuries: Pathophysiology and Potential Therapeutic Targets. Front Cell Neurosci. 2019 Nov 27;13:528. doi: 10.3389/fncel.2019.00528. eCollection 2019.

    PubMed 31827423

  • Murdoch I, Surda P, Nguyen-Lu N. Anaesthesia for rhinological surgery. BJA Educ. 2021 Jun;21(6):225-231. doi: 10.1016/j.bjae.2021.02.004. Epub 2021 Mar 23. No abstract available.

    PubMed 34026276

  • Liu X, Li Y, Kang L, Wang Q. Recent Advances in the Clinical Value and Potential of Dexmedetomidine. J Inflamm Res. 2021 Dec 30;14:7507-7527. doi: 10.2147/JIR.S346089. eCollection 2021.

    PubMed 35002284

  • Li Y, He R, Chen S, Qu Y. Effect of dexmedetomidine on early postoperative cognitive dysfunction and peri-operative inflammation in elderly patients undergoing laparoscopic cholecystectomy. Exp Ther Med. 2015 Nov;10(5):1635-1642. doi: 10.3892/etm.2015.2726. Epub 2015 Sep 4.

    PubMed 26640530

  • Kim H. Anesthetic management of the traumatic brain injury patients undergoing non-neurosurgery. Anesth Pain Med (Seoul). 2023 Apr;18(2):104-113. doi: 10.17085/apm.23017. Epub 2023 Apr 28.

    PubMed 37183278

  • Huang Y, Deng Y, Zhang R, Meng M, Chen D. Comparing the Effect of Dexmedetomidine and Midazolam in Patients with Brain Injury. Brain Sci. 2022 Jun 8;12(6):752. doi: 10.3390/brainsci12060752.

    PubMed 35741637

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine and Sufentanyl in people with Traumatic Brain Injury, run by Universitas Jenderal Soedirman at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in C-Reactive Protein (CRP) Levels (time frame: Baseline (Pre-operative), 6 hours and 24 hours post-operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07406555, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in