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临床试验/NCT07644663
NCT07644663尚未招募4 期

Propofol, Dexmedetomidine, and Esketamine-Induced Unresponsive States: Alterations in Information Integration and Brain Networks

Fudan University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年6月9日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
入组人数
120
试验地点
1

研究概览

简要总结

This study aims to analyze the electroencephalographic power spectrum and connectivity during unresponsive states induced by propofol, esketamine and dexmedetomidine, respectively. It intends to explore the macro neural mechanisms underlying anesthetic unresponsiveness, so as to further elucidate the mechanisms by which anesthetics induce loss and recovery of consciousness. In addition, this study will identify neural biomarkers under general anesthesia for monitoring patients' actual intraoperative consciousness status. The findings will facilitate the development of monitoring indicators and devices reflecting intraoperative consciousness during general anesthesia, enabling more accurate assessment of patients' intraoperative consciousness status.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

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

  • Patients scheduled for elective non-cardiac surgery;
  • American Society of Anesthesiologists (ASA) physical status classification I-II;
  • Aged 18 to 65 years, regardless of gender;
  • Body mass index (BMI) greater than 18 kg/m² and no more than 31 kg/m²;
  • Written informed consent voluntarily signed by the patient or legal authorized representative for participation in this study.

排除标准

  • Subjects meeting any one of the following items will be excluded from this study:
  • Presence of severe cardiovascular diseases or hepatic and renal insufficiency;
  • Hearing impairment;
  • History of psychiatric disorders or communication disorders;
  • Anticipated difficult airway;
  • Pregnant or lactating women;
  • History of allergic reaction or contraindication to any of the three anesthetic drugs used in this trial;
  • Participation in other clinical trials within the past 3 months.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun Zhang

Director of Anesthesiology Department, Fudan University Shanghai Cancer Center

Fudan University

研究点 (1)

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