跳至主要内容
临床试验/NCT05800639
NCT05800639招募中不适用

Mediation Role of Perioperative Electroencephalogram Frontal Alpha Asymmetry to Pediatric Emergence Delirium

Gangnam Severance Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
The peak PAED score

研究概览

简要总结

This study aimed to investigate whether the association between the preoperative anxiety level and emergence delirium involves EEG frontal alpha asymmetry in pediatric patients undergoing ophthalmic surgery under general anesthesia. The investigators hypothesized that EEG frontal alpha asymmetry contributes a significant portion of the preoperative anxiety - emergence delirium association in pediatric patients. Mediation analysis will be performed to estimate the relationships between preoperative anxiety of children (modified Yale Preoperative Anxiety Scale (mYPAS)), EEG frontal alpha asymmetry, and emergence delirium (Pediatric Assessment of Emergence Delirium (PAED) scale).

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
2 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 2-8 year
  • Children with an American Society of Anesthesiologists (ASA) physical status of I-II
  • Children who are scheduled to undergo elective ophthalmological requiring general anesthesia

排除标准

  • Emergency surgery
  • Patients with developmental delays
  • Patients with neurological or psychiatric diseases associated with symptoms of agitation, anxiety, attention deficit, sleep disturbances
  • Patients with autism
  • Patients with a recent history (within one month) of receiving general anesthesia
  • Patients with congenital or genetic diseases that may influence brain development

结局指标

主要结局

The peak PAED score

时间窗: After the completion of surgery, during the PACU stay. PAED score will be measured every 10 minutes during the PACU stay.

The peak PAED score is the primary outcome variable for mediation analysis

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

Young Song

Professor

Gangnam Severance Hospital

研究点 (1)

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