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

Completed

• Conditions: Postoperative Delirium; Sleep Disorder; Strabismus

• Registration Number: NCT03332407
• Lead Sponsor: Pusan National University Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2017-05-02
• Primary Completion: 2017-09-30
• Study Completion: 2017-09-30
• Study First Submitted: 2017-10-22
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-01
• Last Update Submitted: 2017-11-05
• Study First Posted: 2017-11-06
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

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

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Exclusion Criteria

• Any underlying diseases
• Disagree

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preoperative Pittsburgh Sleep Quality Index(PSQI)	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)	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	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.
Postoperative Pittsburgh Sleep Quality Index(PSQI)	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.

Trial Locations

Locations (1)

Pusan national university hospital; 🇰🇷 Busan, Korea, Republic of