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临床试验/NCT07630922
NCT07630922已完成不适用

The Effect of Intraoperative Auditory Intervention on Emergence Delirium After Sevoflurane Anesthesia in Preschool Children

Henan Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
1

研究概览

简要总结

Emergence delirium (ED), characterized by disorientation and altered cognitive behavior, is a common postoperative complication in pediatric surgery. It manifests as lack of eye contact with caregivers or parents, aimless kicking and screaming, and inability to be soothed. Auditory stimulation has been shown to reduce the incidence of ED and postoperative pain during emergence following general anesthesia in children. Therefore, this study aimed to investigate the effects of different types of auditory interventions on the incidence of emergence delirium in children undergoing tonsillectomy and/or adenoidectomy under sevoflurane anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Participants will be randomly assigned to one of four groups (e.g., by coin toss or lottery draw) with a 1:1:1:1 allocation ratio between the experimental and control groups. Neither participants, caregivers, nor outcome assessors will be aware of the group assignment.

入排标准

年龄范围
3 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age between 3 and 7 years;
  • American Society of Anesthesiologists (ASA) physical status classification of I or II;
  • Pediatric patients scheduled for elective tonsillectomy and/or adenoidectomy under sevoflurane general anesthesia.

排除标准

  • Emergency surgery
  • The child has developmental delays or neurological disorders, deafness, or hearing impairment
  • The mother is deaf or absent
  • The patient and family members declined to participate.

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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