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临床试验/NCT06079710
NCT06079710尚未招募不适用

Jiangxi Provincial Children's Hospital

Second Affiliated Hospital of Nanchang University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Incidence of emergence agitation

研究概览

简要总结

The purpose of this study was to analyze the relationship between intraoperative and awakening electroencephalogram waveforms and awakening agitation after general anesthesia in children

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 Year 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The age of the child is 1-10 years old, regardless of gender;
  • ASA grading I to II;
  • Children undergoing hernia, appendix, or small orthopedic surgery under selective general anesthesia

排除标准

  • Respiratory infection occurred within 1 week before surgery;
  • Potential or existing contraindications to general anesthesia;
  • Significant abnormalities in blood routine or biochemical indicators;
  • Patients with cognitive function, mental illness, or neurodevelopmental delay;
  • Unable to cooperate in completing the test, the child's guardian refused to participate;
  • Other reasons why researchers believe it is not suitable to participate in this experiment.

结局指标

主要结局

Incidence of emergence agitation

时间窗: The entire period from entering the recovery room to leaving the recovery room. Approximately 10 min-2 hours

The level of postoperative emergence agitation (EA) was assessed using the pediatric anesthesia emergence delirium Scale (PAED) and the emergence agitation 5 Scale immediately after extubation, and then every 15 min until the child was returned to the ward. emergence agitation was defined as a PAED score of ≥12 or a emergence agitation 5 scale of \>3.

次要结局

  • Postoperative pain intensity(The entire period from entering the recovery room to leaving the recovery room. Approximately 10 min-2 hours)
  • Compatibility during anesthesia induction period(Anesthesia induction period, up to 2 minutes)
  • emergence time(Approximately 5 min-2 hours)

研究者

发起方
Second Affiliated Hospital of Nanchang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fuzhou Hua

Chief Physician

Second Affiliated Hospital of Nanchang University

研究点 (1)

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