Randomized Control Trial for Awake vs. Asleep Craniotomy for Non-eloquent Gliomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Extent of resection
研究概览
简要总结
This study protocol examines a comparison between local and general anesthesia (Awake vs. Asleep Craniotomy) in the removal of brain tumors that are in areas of the brain that do not directly control bodily functions (non-eloquent gliomas).
详细描述
This is a single-center, prospective randomized open or non-blinded end-point (PROBE) clinical trial. Patients will be selected by the neurosurgeon according to the inclusion and exclusion criteria. Patients who consent to randomization will have confirmed non-eloquent status confirmed by independent surgeon and will be randomized into 1 of 2 treatment groups utilizing a dynamic minimization approach. The experimental group with randomization of patients who will undergo awake craniotomy for both high and low grade gliomas in non-eloquent areas or a control group of patients who will have asleep craniotomy for both high and low grade gliomas in non-eloquent regions.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with age ≥18 years old.
- •WHO grade I, II, III, and IV Glioma in non-eloquent brain cortex based on magnetic resonance imaging (MRI)
- •An elective procedure.
- •A single lesion.
- •No major comorbidities that would necessitate an extended hospital stay.
- •Newly diagnosed tumors.
排除标准
- •Patients with age < 18 years old.
- •Non-gliomas
- •Eloquent location (motor, sensory, language)
- •Non-elective procedure.
- •Multiple lesions.
- •Major comorbidities.
- •Recurrent tumors.
- •Patients lacking capacity to consent.
研究组 & 干预措施
Non-Awake Cohort
Cohort undergoing craniotomy utilizing general anesthesia protocol
干预措施: Non-awake Anesthesia Protocol (Procedure)
Awake Cohort
Cohort undergoing craniotomy utilizing awake anesthesia protocol
干预措施: Awake Anesthesia Protocol (Procedure)
结局指标
主要结局
Extent of resection
时间窗: up to 48 hrs post operation
Extent of resection (EOR) defined as the residual volume, in cm3, of tumor measured by MRI
次要结局
- Percentage of baseline tumor volume resected(up to 48 hrs post operation)
- Length of Surgery(Intraoperative)
- VAS Postoperative anxiety(Day 1(+14 days) , Post op day 0, 1, 2 weeks, 3mth)
研究者
Kaisorn L. Chaichana
Senior Associate Consultant
Mayo Clinic