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临床试验/NCT03332407
NCT03332407已完成不适用

Does Preoperative Sleep Quality Affect the Postoperative Emergence Delirium in Children Undergoing Strabismus Surgery?

Pusan National University Hospital1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2017年5月2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
67
试验地点
1
主要终点
Postoperative Pittsburgh Sleep Quality Index(PSQI)

研究概览

简要总结

Sleep is important in maintaining the physiological function of the human body. Recently several studies have reported that preoperative sleep quality is associated with postoperative emergence delirium (ED) The ED is a common in pediatric patients undergoing general anesthesia with sevoflurane, but studies on the association of sleep quality have been rare. The investigators, therefore, aimed to investigate the relationship between postoperative delirium and pre and postoperative sleep quality in pediatric patients receiving strabismus surgery through this study

详细描述

This study aimed on pediatric patients aged 4-12 years, undergoing elective strabismus surgery. Informed consent was obtained from both parents and children on the day of pre-anesthetic evaluation visit. The child and his or her parents were questioned on preoperative patient's sleep quality based on Pittsburg Sleep Quality Index (PSQI). Surgery was performed under the same anesthesia as usual. After the operation, extubation was performed and patient was moved to post anesthesia recovery room (PACU). During the stay in PACU, one investigator measured degree of ED by Watcha and PAED (Post anesthesia emergence delirium ) scale to minimize bias. One day after the surgery, the investigator mede a phone call to the parents of the patient to obtain information for postoperative PSQI.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy children without any underlying diseases
  • 4~12 years old
  • Undergoing strabismus surgery

排除标准

  • Any underlying diseases

结局指标

主要结局

Postoperative Pittsburgh Sleep Quality Index(PSQI)

时间窗: 1 day after the surgery ( < 24 hours )

1. Add the Seven component score. Score range : 0\~27 2. A total score of "5" or greater is indicative of poor sleep quality.

Preoperative Pittsburgh Sleep Quality Index(PSQI)

时间窗: 1. Before the surgery ( Within a week before the surgery)

1. Add the Seven component score. Score range : 0\~27 2. A total score of "5" or greater is indicative of poor sleep quality.

Watcha scale (For emergence delirium)

时间窗: 20 min after awakening ( In the post anesthesia recovery room)

1. Measure the score of most appropriate state of condition. There are four conditions. Score range : 1\~4 2. The score of "3" or greater is indicative of emergence delirium

Pediatric anesthesia emergence delirium scale (PAED) scale

时间窗: 20 min after awakening ( In the post anesthesia recovery room)

1. Add the five component score. Score range : 0\~20 2. A total score of "10" or greater is indicative of emergence delirium.

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

Hyeon-Jeong Lee

Associated professor

Pusan National University Hospital

研究点 (1)

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