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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in C-Reactive Protein (CRP) Levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Dexmedetomidine Group
Patients undergoing craniotomy for traumatic brain injury who receive Dexmedetomidine administration.
干预措施: Dexmedetomidine (Drug)
control
Patients undergoing craniotomy for traumatic brain injury receiving Sufentanyl as the standard analgesic/sedative agent.
干预措施: Sufentanyl (Drug)
结局指标
主要结局
Change in C-Reactive Protein (CRP) Levels
时间窗: Baseline (Pre-operative), 6 hours and 24 hours post-operative
Serum CRP levels measured to assess the inflammatory response
次要结局
未报告次要终点
研究者
Adrian Nugraha Putra
Principal Investigator
Universitas Jenderal Soedirman