Effects of Propofol on Auditory Event-related Potentials and Brain Functional Connectivity in Patients With Supratentorial Glioma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The amplitude of auditory event-related potential
研究概览
简要总结
The growth of gliomas often infiltrates important brain tissues and impairs subcortical fiber transmission, resulting in changes in global brain network connectivity. Most of the current anesthesia depth monitoring methods are based on healthy brain function population，which is difficult to reflect the sedation depth of glioma patients accurately. Therefore, this study aims to explore the characteristics of brain network connectivity in glioma patients under different sedation depths by electroencephalogram (EEG) and auditory event-related potential (AERP) methods, which may provide a research basis for sedative titration and anesthesia depth identification in glioma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 60 years old;
- •American Society of Anesthesiologists (ASA) physical status rating I-II;
- •Supratentorial glioma (frontal, temporal, parietal, insular ；WHO grade I-III);
- •Native Chinese speaker;
- •Signed informed consent.
排除标准
- •Mallampati airway class≥III;
- •BMI>30kg/m2;
- •Combined OSAS or Stop-BANG score≥3;
- •Hearing impairment
- •Combined epilepsy symptoms
- •Recurrent or multiple intracranial tumors
- •Concomitant other psychiatric or neurological disorders
- •Pregnancy and lactation
研究组 & 干预措施
Healthy volunteers
干预措施: Propofol Injection (Drug)
supratentorial glioma patients
干预措施: Propofol Injection (Drug)
结局指标
主要结局
The amplitude of auditory event-related potential
时间窗: During the trial(up to 3 hours for each subject)
The amplitude of MMN and P300
The latency of auditory event-related potential
时间窗: During the trial(up to 3 hours for each subject)
The latency of MMN and P300
次要结局
- Brain network functional connectivity(During the trial(up to 3 hours for each subject))
研究者
Ruquan Han
Head of anesthesiology, Principal Investigator, Clinical Professor
Beijing Tiantan Hospital