跳至主要内容
临床试验/NCT06580028
NCT06580028招募中不适用

Electroencephalogram Study in Children Under Sevoflurane Anesthesia - a Prospective,Observational Study

Second Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2024年9月4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
280
试验地点
1
主要终点
Time-frequency characteristics of electroencephalogram (EEG)

研究概览

简要总结

Sevoflurane is one of the most commonly used volatile anesthetics in children because of its rapid induction, recovery and recovery properties. Clinical studies using noninvasive brain monitoring have shown that general anesthetics and hypnotics generate electroencephalogram (EEG) oscillations in specific spatial tissues that are fundamentally related to the structure and function of neural circuits. Slow-wave-delta (0.1-4 Hz) oscillations were present in children of all ages, and the advantage of frontal α-wave oscillations appeared at approximately 6 months, began to be consistent at 10 months, and persisted at older ages. Another study, which analyzed EEG under sevoflurane general anesthesia in children aged 0-6 months, found that Theta and alpha wave power decreased with a decrease in sevoflurane concentrations in infants between 4 and 6 months of recovery. However, these studies lack detailed characterization of the neural circuit activity associated with anesthesia, especially at specific developmental ages that are highly correlated with brain plasticity. The aim of this study was to explore electroencephalogram (EEG) of children of different ages under sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery) . By analyzing these EEG data in detail, we hope to be able to better understand the EEG characteristics of children of different ages under sevoflurane anesthesia, and thus develop a neurophysiology pediatric anesthesia status monitoring strategy.

详细描述

This study is prospective and observational. Children under sevoflurane general anesthesia were divided into 14 groups (0-3 months old, 3-6 months old, 6-9 months old, 9-12 months old, 1-1.5 years old, 1.5-2 years old, 2-2.5 years old, 2.5-3 years old, 3-3.5 years old, 3.5-4 years old, 4-4.5 years old, 4.5.5 years old, 5.5.5 years old, 5.5-6 years old) , there were 20 cases in each group. Inform the family about the research plan and obtain informed consent. To observe the time-frequency characteristics of prefrontal electroencephalogram (EEG) in children of different ages under general anesthesia with sevoflurane.

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 Day 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • aged 1 days#6 years#;
  • with American Society of Anesthesiologists (ASA) physical status I or II#;
  • children requiring general anesthesia under sevoflurane;
  • parents or legal guardians of children who volunteered to participate in the trial; And signed the informed consent form.

排除标准

  • Congenital malformation or other genetic conditions that are thought to affect brain development ;
  • History of severe heart, brain, liver, kidney and metabolic diseases ;
  • Premature infants (≤32 weeks);
  • Upper respiratory tract infection in the last two weeks.

结局指标

主要结局

Time-frequency characteristics of electroencephalogram (EEG)

时间窗: during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery)

Time-frequency characteristics of electroencephalogram (EEG) in children of different ages during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery) .

次要结局

  • Modified observer's assessment of alertness#sedation#MOAA/S#scale(during sevoflurane general anesthesia (including anesthesia induction, maintenance and recovery))
  • Recovery time(Within up to 30 minutes after operation)
  • Pediatric anesthesia emergence delirium(Within up to 30 minutes after operation)
  • The Face, Legs, Activity, Cry, Consolability Scale (FLACC)(Within up to 30 minutes after operation)
  • PHBQ-AS(3 days after operation)

研究者

发起方
Second Affiliated Hospital of Wenzhou Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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