General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas: a Randomised, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Dynamics of early motor function (in grades)
研究概览
简要总结
Objective of the study is to determine whether resection of gliomas and metastases of motor areas using awake surgery can achieve rarer motor deterioration after operation than using general anesthesia.
详细描述
Awake surgery is usually used for tumor resection located in language areas. But patient's awakening during removal of mass lesions from motor areas can give additional opportunities. Besides checking of muscle contractions and integrity of motor fibers a surgeon in awake patient can assess planning of movements, praxis, visual feedback and vestibular processing of motions. Preserving of voluntary movements can be an additional proof that cortical motor centers and corticospinal tract were not damaged. At the moment there are no published results of randomized trials showing advantage of awake surgery in removal of mass lesions from motor brain areas.
Objective of the study is to determine whether resection of gliomas and metastases of motor areas using awake surgery can achieve rarer motor deterioration after operation than using general anesthesia.
Participants of the study will be randomly operated using awake surgery or general anesthesia. In both groups intraoperative neuromonitoring will be used. Dynamics of motor functions will be assessed before and after surgery by blinded neurologists.
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)
盲法说明
Dynamics of motor function before, within 10 days after surgery and in 3 months after surgery will be assessed by neurosurgeon blinded for the treatment arm
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •single gliomas without contrast enhancement in preoperative magnetic resonance imaging (presumed low-grade gliomas)
- •single gliomas with contrast enhancement in preoperative magnetic resonance imaging (presumed high-grade gliomas)
- •one or several brain metastases from any cancer
- •location near primary motor area or corticospinal tract
- •newly diagnosed
- •Karnofsky Performance Status 60-100%
- •muscle strength in assessed limbs 3-5 points in Medical Research Council scale
- •age 18-69 years
- •body mass index 29 and less
- •hemoglobin 110 and more
- •platelets 100 and more
- •international normalized ratio less than 2,0
- •presumed blood loss no more than 8-10 percents of circulating blood volume (no more than 450-650 milliliters)
排除标准
- •chronic obstructive pulmonary disease
- •persistent smoker (smoking index 11 and more)
- •major comorbidities
- •implanted pacemaker
- •inability to perform intraoperative tests before surgery
- •severe aphasia
- •psychiatric disorders
- •barely controlled seizures
- •contraindications to magnetic resonance imaging
- •previously performed brain radiotherapy
- •pregnancy
- •breast feeding
研究组 & 干预措施
Awake surgery
Critical steps of brain mapping and tumor removal will be performed in awake patient
干预措施: Tumor resection in awake patient (Procedure)
General anesthesia
Brain mapping and tumor removal will be performed in asleep patient
干预措施: Tumor resection in asleep patient (Procedure)
结局指标
主要结局
Dynamics of early motor function (in grades)
时间窗: within 10 days after surgery
Early motor function is assessed in Medical Research Council scale and is compared before and after surgery
Dynamics of late motor function (in grades)
时间窗: in 3 months after surgery
Late motor function is assessed in Medical Research Council scale and is compared before and in 3 months after surgery
Composite event of deterioration of early motor function, severe disturbance of consciousness or death from any cause
时间窗: within 10 days after surgery
Motor function is assessed in Medical Research Council scale and is compared before and after surgery, deterioration of motor function means decline of 1 grade or more; level of consciousness is assessed in Glasgow Coma scale, it's severe disturbance means decline to 9 points or less
次要结局
- Early speech function (in grades)(within 10 days after surgery)
- Extent of resection (in percents)(within 48 hours after surgery)
- Intraoperative blood loss (in milliliters)(Intraoperatively)
- Duration of hospital stay (in days)(From admission to the hospital till hospital discharge, up to 365 days)
- Repeated hospital admission (Yes or No)(within 3 months after surgery)
- Composite event of deterioration of early speech, severe disturbance of consciousness or death from any cause(within 10 days after surgery)
- Early Karnofsky performance status (in percents)(within 10 days after surgery)
- Duration of surgery (in minutes)(Intraoperatively)
- Cerebral complications(within 3 months after surgery)
- Somatic complications(From admission to intensive care unit after surgery till hospital discharge, up to 365 days)
- Gross total resection (Yes or No)(within 48 hours after surgery)
- Duration of stay in intensive care unit (in days)(From admission to intensive care unit after surgery till transfer to neurosurgical unit, up to 365 days)
- Late speech function (in grades)(in 3 months after surgery)
- Late Karnofsky performance status (in percents)(in 3 months after surgery)
研究者
Alexander Dmitriev
Principal Investigator
Sklifosovsky Institute of Emergency Care