NEURANESTH General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematomas: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- postoperative theoretical length of stay
研究概览
简要总结
This study compare general anesthesia versus locoregional anesthesia for evacuation of chronic subdural hematoma. Half of participant will be operated under general anesthesia, while the other half will be operated under locoregional anesthesia.
详细描述
General anesthesia is the most common technique for this surgery. The local anesthesia is less common but it allows to obtain the same surgical result. This last technique being more recent little study compared these two techniques in terms of complications and postoperative consequences.
The investigators will randomize patients into two groups (a general anesthesia group and a locoregional anesthesia group).
General anesthesia provides complete immobility and optimal surgical comfort but is a source of multiple complications, especially in a population of polypathological and polymedicated elderly patients (which is the population affected by chronic subdural hematomas).
Locoregional anesthesia requires special technical training, leads to complete analgesia of the surgical procedure but does not involve complete immobility of the patient, however this technique probably leads to less postoperative complications and allows a more early rehabilitation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subdural chronic hematoma uni or bilateral
- •Obtaining an oral consent
- •french speaker
- •affilliation to French social security
排除标准
- •Patients agitated or not cooperating, not allowing the realization of a locoregional anesthesia
- •Patients with other intracranial lesions
- •Patients with underlying neurological pathology with a modified Rankin score greater than 1
- •Pregnant or lactating women
- •Patients under guardianship / curatorship
研究组 & 干预措施
All General anesthesia
Use of a hypnotic("propofol 2.5mg/kg"), morphine("remifentanil1yg/kg") and curare("atracurium0.5mg/kg"), with the support of orotracheal intubation and mechanical ventilation
干预措施: All General anesthesia (Drug)
All Locoregional anesthesia
Use of a local anesthetic(" xylocaine 1%") for the realization of scalp nerve block
干预措施: All Locoregional anesthesia (Drug)
结局指标
主要结局
postoperative theoretical length of stay
时间窗: 10 days
Theoretical duration of postoperative hospitalization: discharge authorized after medical checklist
次要结局
- MINI COG: Measurement of postoperative cognitive impairment at 6 months(2 days)
- Modified Rankin score (0-6)(3 month)
- LIKERT scale: a measure of the degree of satisfaction of the surgeon and the patient.(baseline)
- Rates of postoperative surgical complications(10 days)
- Postoperative medical complications rate(10 days)
- Mortality rate at 6 months.(6 month)
- Simple numeric scale for postoperative pain(2 days)
- Opioid consumption(10 days)
- Admission rate in Intensive care unit(3 month)