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临床试验/NCT05823454
NCT05823454招募中不适用

Consciousness-specific Brain Network Connection of Propofol Sedation and Prolonged Disorders of Consciousness Based on Electroencephalogram and Event-related Potential

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年9月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
EEG Spectral Characteristics

研究概览

简要总结

Consciousness-specific Brain Network Connection of Propofol Sedation and Prolonged Disorders of Consciousness based on Electroencephalography and Auditory Event-related Potentials

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

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

入选标准

  • Age 18 - 65 years old, native Chinese speaker, dextromanuality;
  • Chronic disorder of consciousness;
  • Spinal cord electrical stimulator implantation under general anesthesia;
  • Signed informed consent.

排除标准

  • Continuous sedation was administered within 72 hours prior to the study;
  • Open head injury, parenchymatectomy and other damage of brain structural integrity;
  • The intracranial compliance decreased due to hydrocephalus and swelling;
  • Known hearing impairment;
  • Airway stenosis and various causes of severe ventilation or ventilation dysfunction;
  • Known or suspected cardiac dysfunction;
  • Allergic to intravenous general anesthetics;
  • Associated with other mental or neurological diseases;
  • Other reasons are not suitable to participate in this study.

研究组 & 干预措施

Propofol

Intravenous infusion

干预措施: Different drug dosage (Drug)

Dexmedetomidine

Intravenous infusion

干预措施: Different drug dosage (Drug)

Esketamine

Intravenous infusion

干预措施: Different drug dosage (Drug)

Sevoflurane

Inhalation anesthesia

干预措施: Different drug dosage (Drug)

Remifentanil

Intravenous infusion

干预措施: Different drug dosage (Drug)

结局指标

主要结局

EEG Spectral Characteristics

时间窗: During the trial(up to 3 hours for each subject)

Characteristics of EEG power spectrum(for 1-30 Hz) in patients with chronic consciousness disorder under different doses of drugs

次要结局

  • Cortical Connectivity(During the trial(up to 3 hours for each subject))
  • Derived quantitative indicators(During the trial(up to 3 hours for each subject))
  • Dynamic Patterns of Cortical Connectivity(During the trial(up to 3 hours for each subject))
  • Characteristics of sleep(During the trial(up to 24 hours for each subject))
  • Rate of patients recovered consciousness after surgery(During the trial(through study completion, 180 days))

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruquan Han

Professor

Beijing Tiantan Hospital

研究点 (1)

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