An observational study in Postoperative Delirium, Strabismus and Sleep Disorder, sponsored by Pusan National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 4 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-07.
Sponsored by Pusan National University Hospital · Observational
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
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.
751 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.
This study's enrollment of 67 is below the median of 162 across 279 observational studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →Pusan National University Hospital is the lead sponsor of 80 studies on the registry; 8 are open to participants now.
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Subject of this study is pediatric patients aged 4\~12 years, undergoing elective strabismus surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Preoperative Pittsburgh Sleep Quality Index(PSQI)
1. Add the Seven component score. Score range : 0\~27 2. A total score of "5" or greater is indicative of poor sleep quality.
Time frame: 1. Before the surgery ( Within a week before the surgery)
Watcha scale (For emergence delirium)
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
Time frame: 20 min after awakening ( In the post anesthesia recovery room)
Pediatric anesthesia emergence delirium scale (PAED) scale
1. Add the five component score. Score range : 0\~20 2. A total score of "10" or greater is indicative of emergence delirium.
Time frame: 20 min after awakening ( In the post anesthesia recovery room)
Postoperative Pittsburgh Sleep Quality Index(PSQI)
1. Add the Seven component score. Score range : 0\~27 2. A total score of "5" or greater is indicative of poor sleep quality.
Time frame: 1 day after the surgery ( < 24 hours )
Plan to share: No
Ran from May 2017 to primary completion in Sep 2017, 4 months.
Of 181 non-industry observational studies under Emergence Delirium, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 4 months is below that.
Counting every sponsor, half of 181 studies reached it within 21 months; a quarter within 10 and three quarters within 43.
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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Pusan National University Hospital