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临床试验/NCT03358069
NCT03358069已完成不适用

Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?

Prince of Songkla University1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
1
主要终点
emergence agitation

研究概览

简要总结

Emergence agitation (EA) is one of the unpleasant symptoms after general anesthesia. The patient can be irritable, uncooperate, cry, moan and combative behaviors. Sometimes the patient may need to be thrashed to prevent physical harm. The mechanism of EA is still unknown. EA is usually self limiting within 45 to 60 minutes after wake up from anesthesia. The incidence of EA is much higher in pediatric group when compared with adult. In some centre the incidence of EA can be up to 67 % depends on anesthesia technique, race, and child's temperament. Kain et al, reported that the patient who had marked EA tended to have post operative maladaptive behaviors. These maladaptive behaviors such as insomnia, eating disturbance, aggressive behavior and even developmental regression can be happen until one year after anesthesia.

From the previous study, reported that fast emergence was associated with a high incidence of agitation.

This prospective observation study is conducted to determine that emergence time has any effect on EA or not. The authors use process electroencephalogram (entropy) to monitor emergence time which defined as the time which state entropy level over sixty to eighty. Meanwhile, we will evaluate the emergence time by the conventional method which used the time from ceasing anesthesia to the time of eye opening by normal voice stimuli.

The primary outcome of this study is the correlation between emergence time (both from Process EEG and clinical presentation) and incidence of emergence agitation. Two secondary outcomes will be measured. Firstly, the correlation between emergence time and postoperative behavioral changes. Secondly, the relationship between entropy monitoring and clinical symptoms.

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
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patient aged between 3-12 years, ASA physical status I-II who is scheduled for inpatient elective surgery

排除标准

  • emergency surgery, neurosurgery, antiepileptic medication taken and having ICU admission planning.

结局指标

主要结局

emergence agitation

时间窗: evaluate patient within the first 5 minutes after patient arrive PACU

Pediatric Anesthesia Emergence delirium scale (PAED) PAED \> 10 defined as EA positive

次要结局

  • Post operative behavioral changes(up to 7 days postoperative period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ngamjit Pattaravit

Asst. Prof.

Prince of Songkla University

研究点 (1)

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