A Randomized Controlled Trial Comparing the Effectiveness of Dexmedetomidine Versus Sufentanil on Cerebral Oxygen Saturation in Patients With Traumatic Brain Injury (DESTIN Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Cerebral oxygen saturation (rSO₂) measured by Near-Infrared Spectroscopy (NIRS)
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the effectiveness of dexmedetomidine compared with sufentanil on cerebral oxygen saturation in patients with traumatic brain injury (TBI) undergoing surgery under general anesthesia. Cerebral oxygen saturation (rSO₂) will be monitored using Near-Infrared Spectroscopy (NIRS) to assess the impact of both anesthetic regimens on cerebral oxygenation and hemodynamic stability.
Patients meeting the inclusion criteria will be randomly assigned into two groups (1:1 ratio) using a simple random draw method.
Group A will receive dexmedetomidine 1 µg/kg for induction, thiopental 5 mg/kg, and rocuronium 0.6 mg/kg, followed by maintenance with dexmedetomidine 0.3 µg/kg/hour and sevoflurane 1-1.5 vol%.
Group B will receive sufentanil 0.2 µg/kg for induction, thiopental 5 mg/kg, and rocuronium 0.6 mg/kg, followed by maintenance with sufentanil 0.2 µg/kg/hour and sevoflurane 1-1.5 vol%. Both groups will receive intravenous paracetamol 1 g for analgesia at the end of surgery.
All patients will remain intubated postoperatively and will be transferred to the Intensive Care Unit (ICU) for monitoring. NIRS probes will be placed bilaterally on the cleaned frontal regions to measure rSO₂ values preoperatively, intraoperatively, and postoperatively at 60 and 120 minutes after intervention.
Postoperative analgesia will consist of dexmedetomidine 0.3 µg/kg/hour with paracetamol 1 g every 8 hours in the dexmedetomidine group, and sufentanil 0.1 µg/kg/hour with paracetamol 1 g every 8 hours in the sufentanil group.
Clinical and hemodynamic parameters will be recorded throughout the perioperative period.
Data will be analyzed to compare cerebral oxygen saturation changes between the two groups, aiming to determine whether dexmedetomidine provides superior cerebral oxygenation compared with sufentanil in patients with traumatic brain injury undergoing neurosurgical procedures.
详细描述
Traumatic brain injury (TBI) is a major cause of morbidity and mortality worldwide, often leading to secondary brain injury caused by hypoxia, ischemia, and impaired cerebral autoregulation. During anesthesia and surgery, maintaining adequate cerebral oxygenation is critical to prevent secondary neuronal damage. Cerebral oxygen saturation, measured by Near-Infrared Spectroscopy (NIRS), provides a continuous and noninvasive assessment of regional cerebral oxygenation (rSO₂), reflecting the balance between oxygen delivery and consumption in brain tissue.
Opioids such as sufentanil have traditionally been used to provide analgesia and hemodynamic stability during anesthesia in neurosurgical patients. However, opioid-related adverse effects, including respiratory depression, hypercapnia, and potential increases in intracranial pressure, raise concerns in patients with brain injury. Dexmedetomidine, a selective α₂-adrenergic receptor agonist, has sedative, analgesic, and sympatholytic properties without significant respiratory depression. It is known to reduce cerebral metabolic rate and intracranial pressure while maintaining cerebral perfusion, making it a potentially advantageous agent in neuroanesthesia.
This randomized controlled clinical trial aims to compare the effectiveness of dexmedetomidine versus sufentanil on cerebral oxygen saturation in patients with traumatic brain injury undergoing surgery. The hypothesis is that dexmedetomidine provides better maintenance of cerebral oxygenation, as measured by NIRS, compared to sufentanil under equivalent anesthetic conditions.
Eligible participants will be randomly allocated into two groups (1:1 ratio). The dexmedetomidine group will receive an induction dose of dexmedetomidine 1 µg/kg, thiopental 5 mg/kg, and rocuronium 0.6 mg/kg, followed by maintenance with dexmedetomidine 0.3 µg/kg/hour and sevoflurane 1-1.5 vol%. The sufentanil group will receive sufentanil 0.2 µg/kg, thiopental 5 mg/kg, and rocuronium 0.6 mg/kg, followed by sufentanil 0.2 µg/kg/hour and sevoflurane 1-1.5 vol%. All patients will receive intravenous paracetamol 1 g at the end of surgery for postoperative analgesia.
Postoperatively, patients will remain intubated and monitored in the Intensive Care Unit (ICU). Cerebral oxygen saturation (rSO₂) will be recorded using NIRS probes placed bilaterally on the frontal region before induction, during surgery, and at 60 and 120 minutes post-intervention in the ICU. Additional hemodynamic parameters including heart rate, mean arterial pressure, and oxygen saturation will also be recorded.
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
- Double (Participant, Care Provider)
盲法说明
This study uses a double-blind design. Both the participants and the principal investigator are blinded to group allocation. Randomization is performed using a simple draw method assigning subjects to Group A or Group B. The anesthetic drugs (dexmedetomidine or sufentanil) are prepared and administered by an anesthesia team member who is not involved in data collection or outcome assessment. The study drugs are provided in identical, unlabeled syringes to ensure blinding. Neither the patients nor the investigator responsible for data recording and analysis will know which drug is administered until the study is completed and unblinding is authorized.
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 18-65 years diagnosed with traumatic brain injury (TBI) requiring surgical intervention under general anesthesia.
- •Classified as ASA Physical Status I-III.
- •Undergoing elective or emergency craniotomy at RSUD Prof. Dr. Margono Soekarjo Purwokerto.
- •Provide informed consent (patient or legal representative).
排除标准
- •Patients with severe cardiovascular instability (e.g., shock, uncontrolled arrhythmia).
- •History of allergy or hypersensitivity to dexmedetomidine or sufentanil.
- •Severe hepatic or renal impairment.
- •Pregnant or lactating women.
- •Glasgow Coma Scale ≤ 8 before induction.
- •Refusal of participation or incomplete consent.
研究组 & 干预措施
Dexmedetomidine group
Patients receive dexmedetomidine 1 µg/kg IV bolus for induction, followed by maintenance infusion at 0.3 µg/kg/h, combined with thiopental 5 mg/kg, rocuronium 0.6 mg/kg, and sevoflurane 1-1.5 vol% for maintenance anesthesia.
干预措施: Dexmedetomidine (Drug)
Sufentanil group
Patients receive sufentanil 0.2 µg/kg IV bolus for induction, followed by maintenance infusion at 0.2 µg/kg/h, combined with thiopental 5 mg/kg, rocuronium 0.6 mg/kg, and sevoflurane 1-1.5 vol% for maintenance anesthesia.
干预措施: Sufentanil (Drug)
结局指标
主要结局
Cerebral oxygen saturation (rSO₂) measured by Near-Infrared Spectroscopy (NIRS)
时间窗: Baseline (before induction), 60 minutes after surgery, and 120 minutes after surgery.
Measurement of regional cerebral oxygen saturation (rSO₂) using Near-Infrared Spectroscopy (NIRS) placed bilaterally on the forehead. The mean rSO₂ values during and after anesthesia will be compared between the dexmedetomidine and sufentanil groups to assess cerebral oxygenation before and after surgery in traumatic brain injury patients.
次要结局
未报告次要终点
研究者
MM Rudi Prihatno
Consultant Neuroanesthesiologist and Dean, Faculty of Medicine, Universitas Jenderal Soedirman
Universitas Jenderal Soedirman