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

Sleep Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332407
• Other study ID #: 2017-1022
• Status: Completed
• Phase: N/A
• First received: October 22, 2017
• Last updated: November 5, 2017
• Start date: May 2, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: November 2017
• Source: Pusan National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

• Healthy children without any underlying diseases

• 4~12 years old

• Undergoing strabismus surgery

Exclusion Criteria:

• Any underlying diseases

• Disagree

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Parasomnias
• Postoperative Delirium
• Sleep Disorder
• Sleep Wake Disorders
• Strabismus

Locations

Country	Name	City	State
Korea, Republic of	Pusan national university hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative Pittsburgh Sleep Quality Index(PSQI)	Add the Seven component score. Score range : 0~27; A total score of "5" or greater is indicative of poor sleep quality.	1. Before the surgery ( Within a week before the surgery)
Primary	Watcha scale (For emergence delirium)	Measure the score of most appropriate state of condition. There are four conditions. Score range : 1~4; The score of "3" or greater is indicative of emergence delirium	20 min after awakening ( In the post anesthesia recovery room)
Primary	Pediatric anesthesia emergence delirium scale (PAED) scale	Add the five component score. Score range : 0~20; A total score of "10" or greater is indicative of emergence delirium.	20 min after awakening ( In the post anesthesia recovery room)
Primary	Postoperative Pittsburgh Sleep Quality Index(PSQI)	Add the Seven component score. Score range : 0~27; A total score of "5" or greater is indicative of poor sleep quality.	1 day after the surgery ( < 24 hours )