Clinical trial NCT03332407: Does Preoperative Sleep Quality Affect the Postoperative Emergence Delirium in Children Undergoing Strabismus Surgery
Official title: Does Preoperative Sleep Quality Affect the Postoperative Emergence Delirium in Children Undergoing Strabismus Surgery?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium
Strabismus
Sleep Disorder
Keywords: Postoperative delirium
Sleep quality
Pediatric anesthesia
Strabismus surgery
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 67
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject of this study is pediatric patients aged 4\~12 years, undergoing elective strabismus surgery.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Any underlying diseases
* Disagree

Primary outcomes:
measure: Preoperative Pittsburgh Sleep Quality Index(PSQI)
timeFrame: 1. Before the surgery ( Within a week before the surgery)
measure: Watcha scale (For emergence delirium)
timeFrame: 20 min after awakening ( In the post anesthesia recovery room)
measure: Pediatric anesthesia emergence delirium scale (PAED) scale
timeFrame: 20 min after awakening ( In the post anesthesia recovery room)
measure: Postoperative Pittsburgh Sleep Quality Index(PSQI)
timeFrame: 1 day after the surgery ( < 24 hours )
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan national university hospital
Study officials:
References:
citation: Do W, Kim HS, Kim SH, Kang H, Lee D, Baik J, Lee HJ, Hong JM. Sleep quality and emergence delirium in children undergoing strabismus surgery: a comparison between preschool- and school-age patients. BMC Anesthesiol. 2021 Nov 22;21(1):290. doi: 10.1186/s12871-021-01507-2.