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临床试验/NCT07272044
NCT07272044招募中不适用

Research on Anesthesia Depth Control Strategy Based on Continuous and Non-invasive Monitoring of Exhaled Breath

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年3月16日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Correlation and consistency analysis between exhaled breath concentrations of two anesthetics and BIS values

研究概览

简要总结

This study aims to propose a strategy for controlling the depth of anesthesia based on continuous and non-invasive monitoring of exhaled breath: BIS value during intravenous-inhalation combined anesthesia is predicted according to the real-time exhaled concentrations of sevoflurane and propofol, so as to achieve the depth of anesthesia management for patients who cannot use standard BIS. Furthermore, the relationship between anesthetic concentration and depth of anesthesia was analyzed in different subgroups.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years old
  • ASA I-III
  • Expected duration of surgery > 1 hour
  • Radial artery catheterization was performed
  • Patients requiring BIS monitoring.

排除标准

  • Patients with contraindications to general anesthesia
  • mental disorder, unable to answer
  • long-term use of antiepileptic drugs and psychotropic drugs
  • pregnant patients
  • patients refused to participate
  • the investigator thought that the study was not suitable for inclusion
  • patients who did not wake up in PACU

结局指标

主要结局

Correlation and consistency analysis between exhaled breath concentrations of two anesthetics and BIS values

时间窗: 1 day

Correlation and consistency analysis between exhaled breath concentrations of two anesthetics detected by GC-SAW system and BIS values

Establish a 3D drug dose-effect model of the exhaled concentration and BIS value of anesthetics

时间窗: 1day

Establish a 3D drug dose-effect model based on the exhaled gas concentration of anesthetics detected by the GC-SAW system and BIS value

次要结局

  • Correlation and consistency analysis of exhaled breath concentration and blood concentration of anesthetics(1day)
  • The incidence of adverse reactions(72 hours)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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