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临床试验/NCT03544502
NCT03544502已完成不适用

Is Music the Food of Anesthesia in Children?

Trakya University0 个研究点目标入组 105 人开始时间: 2013年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
105
主要终点
Postoperatively, Emergence delirium (ED) was assessed as a Pediatric Anesthesia Emergence Delirium

研究概览

简要总结

The patients were randomly separated into three groups. Group M (n=35) applied CD player and Group S (n=35) received the independent anesthesiologist placed earplugs into the patients' ears. Group N (n=35) exposed to the ambient operating room noise.

详细描述

Hundred and five pediatric patients who scheduled for abdominal surgery in ASA I-II risk groups were enrolled in the study. The patients were randomly separated into three groups. Group M (n=35) applied CD player and Group S (n=35) received the independent anesthesiologist placed earplugs into the patients' ears. Group N (n=35) exposed to the ambient operating room noise. The preoperative children's anxiety levels were assessed with the M-YPAS in the operating room. Heart rate (HR) and mid-arterial pressure (MAP) were recorded at 30-minute intervals until the completion of surgery, end of surgery and postoperative. During each measurement, noise level recordings were performed using sonometre. Pediatric Anesthesia Emergence Delirium Score (PEAD) was assessed after extubation, postoperative.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
5 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • scheduled for elective abdominal surgery with an expected operation time of 60 to 120 minutes, were enrolled in the study.

排除标准

  • Children were excluded from the study if they had cognitive disorders, with clinically evident hearing impairment, chronic illness, undergoing emergency surgery, and unstable medical conditions requiring intensive care unit admission.

结局指标

主要结局

Postoperatively, Emergence delirium (ED) was assessed as a Pediatric Anesthesia Emergence Delirium

时间窗: 15 minutes in postoperative

Pediatric Anesthesia Emergence Delirium Score was assessed postoperative 15th minutes.

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

Sevtap Hekimoglu Sahin

Clinical Professor

Trakya University

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