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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Change in C-Reactive Protein (CRP) Levels
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
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
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dexmedetomidine Group
Patients undergoing craniotomy for traumatic brain injury who receive Dexmedetomidine administration.
Intervention: Dexmedetomidine (Drug)
control
Patients undergoing craniotomy for traumatic brain injury receiving Sufentanyl as the standard analgesic/sedative agent.
Intervention: Sufentanyl (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Adrian Nugraha Putra
Principal Investigator
Universitas Jenderal Soedirman