Brain Network Analysis of Anesthesia Characteristics in Patients With Prolonged Disorders of Consciousness Based on Polysomnography
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
- Characteristics of sleep in pDoC patients
研究概览
简要总结
The goal of this prospective, exploratory and observational study is to learn about in healthy volunteers and patients with prolonged disorders of consciousness(pDoC). The main questions it aims to answer are:
- Observe the similarities and differences of polysomnography between pDoC patients and healthy volunteers, and analyze the characteristic brain network changes based on polysomnography
- To observe the similarities and differences of polysomnography in pDoC patients before and after Insertion of spinal cord electric stimulator under general anesthesia,and analyze the changes of anesthesia characteristic brain network in patients with consciousness disorders based on polysomnography.
- To observe the similarities and differences of polysomnography in pDoC patients before and after spinal cord stimulation,and analyze the characteristic changes of brain network after spinal cord stimulation.
We will record the 8h polysomnography of healthy volunteers,record the polysomnography of DOC patients before and 24 hours after operation;and record the 24h polysomnography of patients with spinal cord electric stimulator.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria of health volunteer group:
- •Aged 18-65, native Chinese
- •No history of sleep apnea
- •No history of insomnia
- •Volunteer to participate in this study and obtain informed consent.
- •Inclusion criteria of pDoC group:
- •Aged 18-65, native Chinese
- •pDoC after acquired brain injury
- •The spinal electric stimulator was implanted under general anesthesia
- •Obtain informed consent.
排除标准
- •Healthy volunteers took hypnotic drugs 72 hours before the study
- •Continuous sedation treatment was carried out within 72 hours before the study
- •The integrity of brain structures such as open head injury and brain parenchyma resection
- •Intracranial compliance decreased due to hydrocephalus
- •Airway stenosis and severe ventilation or ventilation dysfunction caused by various reasons
- •Known or suspected to have serious heart, lung and kidney dysfunction
- •Allergic history of sedative drugs
- •Combined with other mental or nervous system diseases
- •Other reasons are not suitable for this study.
研究组 & 干预措施
patients with prolonged disorders of consciousness
干预措施: General Anesthetics (Drug)
结局指标
主要结局
Characteristics of sleep in pDoC patients
时间窗: January 1, 2023 to January 1, 2024
Characteristics of sleep in pDoC patients compared with healthy volunteers
Sleep EEG and characteristic brain network in pDoC patients before and after anesthesia
时间窗: January 1, 2023 to January 1, 2024
Sleep electroencephalogram and characteristic brain network of pDoC patients before and after starting the spinal cord electric stimulator
时间窗: January 1, 2023 to January 1, 2024
Consciousness recovery of patients with pDoC 30 days, 90 days and 180 days after operation
时间窗: January 1, 2023 to January 1, 2024
次要结局
未报告次要终点
研究者
Ruquan Han
professor
Beijing Tiantan Hospital