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临床试验/NCT05210764
NCT05210764招募中不适用

General Anesthetics-related Changes in Prefrontal EEG During Pediatric Surgical Anesthesia

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 366 人开始时间: 2022年6月1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
入组人数
366
试验地点
1
主要终点
bicoherence

研究概览

简要总结

The change profiles of indices derived from pEEG such as phase-amplitude coupling and bicoherence based on individual general anesthetics in children have not been examined in previous literature. Whether those indices have the abilities to predict individual drug-related anesthesia depth in children need to be explored.

详细描述

The need to maintain a proper depth of general anesthesia during pediatric surgery is an important aspect of anesthesiology. An inappropriate anesthesia depth increases the risk of intraoperative awareness or delay in recovery in children undergoing surgery. Current modalities for anesthesia depth monitoring showed limited accuracy in children. The electroencephalogram (EEG) can be analyzed in its raw form for characteristic drug-induced patterns of change or summarized using mathematical parameters as a processed electroencephalogram (pEEG). The change profiles of indices derived from pEEG such as phase-amplitude coupling and bicoherence based on individual general anesthetics in children have not been examined in previous literature. Whether those indices have the abilities to predict individual drug-related anesthesia depth in children need to be explored.

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
1 Minute 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • patients aged 0-18 years, American Society of Anesthesiologists Physical Status I-II, scheduled for elective surgery in Peking University First Hospital.

排除标准

  • Preterm patients;
  • Height and weight not within the standard ranges for respective ages;
  • Surgery for head or heart;
  • Patients with muscular, neurologic or psychiatric diseases;
  • Patients with Congenital anomaly or hereditary diseases;
  • Patients with medication abuse;
  • Allergy to medication including propofol, sevoflurane, and ketamine;
  • Allergy to beans;
  • Refusal to participate the study by guardians.

研究组 & 干预措施

propofol

General anesthesia is induced and maintained mainly with propofol.

干预措施: propofol (Drug)

sevoflurane

General anesthesia is induced and maintained mainly with sevoflurane.

干预措施: sevoflurane (Drug)

ketamine

General anesthesia is induced mainly with S-ketamine and maintained mainly with propofol.

干预措施: S-ketamine (Drug)

结局指标

主要结局

bicoherence

时间窗: induction and maintenance, and recovery of anesthesia

bicoherence

phase-amplitude coupling

时间窗: induction, maintenance, and recovery of anesthesia

phase-amplitude coupling

spectral analysis

时间窗: induction and maintenance, and recovery of anesthesia

spectral analysis

entropy indices

时间窗: induction and maintenance, and recovery of anesthesia

entropy indices

次要结局

未报告次要终点

研究者

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

Dong-Xin Wang

Professor

Peking University First Hospital

研究点 (1)

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