Safety of Nerve Block Anesthesia Combined With Sedative Anesthesia Versus General Anesthesia in Burr Hole Craniostomy With Drainage for Chronic Subdural Hematoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Incidence of intraoperative body movement
研究概览
简要总结
A prospective, multicenter, randomized controlled trial is designed to evaluate the safety of nerve block anesthesia combined with sedative anesthesia versus general anesthesia during burr hole craniostomy with drainage for chronic subdural hematoma.
详细描述
This is a prospective, multi-centre, randomised, controlled, single-blinded, non-inferiority trial. Patients with chronic subdural hematoma undergoing burr-hole drainage will be randomly allocated to receive either the cranial nerve block with dexmedetomidine sedation or general anaesthesia. Patients in the cranial nerve block with dexmedetomidine sedation group will receive cranial nerve block with 0.5% ropivacaine and 1% lidocaine mixture according to incision, combined with dexmedetomidine infusion at a rate of 2-4ug/kg for 10 minutes, followed by a continuous infusion of 0.5 to 1ug/kg/h until the end of the operation. Patients in the general anaesthesia group will be induced with propofol or etomidate, sufentanil, rocuronium or cis-atracurium and be maintained with total intravenous anaesthesia. The primary outcome is the incidence of intraoperative limb movement. Secondary outcomes include postoperative delirium within five days after surgery, anaesthesia conversion, postoperative neurological function, intraoperative awareness, and recurrence rate of hematoma within 6 months after surgery.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic subdural hematoma with preoperative neurological dysfunction for burr hole drainage;
- •Age beween 18 to 80
- •Chronic subdural hematoma verified on cranial computed tomography or magnetic resonance imaging with hematoma thickness >1.0cm or midline shift >1.0 cm.
- •Written informed consent obtained
排除标准
- •Preoperative unconsciousness (Glasgow Coma Scale<13, or Markwalder Grade 2-4) or cognitive dysfunction (Mini-Cog≤3, or MMSE≤20)
- •Preoperative sensory or motor aphasia
- •Recurrence of hematoma with previous surgery for chronic subdural hematoma.
- •Previous intracranial surgery or with intracranial lesion
- •with severe comorbidity or other organ dysfunction
- •Allergic to anesthetics
- •Severe coagulopathy or high risk of life-threatening bleeding
- •Participating in another research
结局指标
主要结局
Incidence of intraoperative body movement
时间窗: During the surgery
Intraoperative body movement is defined as those likely to interfere with surgical procedures such as bending of hand and/or leg and movement of head.
次要结局
- Conversion to general anesthesia(During the surgery)
- Postoperative delirium(1-5 days after surgery)
- Neurological function(at discharge and 6 months after operation)
- Recurrence rate at 6 months after surgery(From operation up to 6 months postoperatively)
- Intraoperative awareness(1 day after surgery)
研究者
Weiming Liu
Professor
Beijing Tiantan Hospital