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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03332407

Enrollment

Registered

2017-11-06

Start date

2017-05-02

Completion date

2017-09-30

Last updated

2017-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium, Sleep Disorder, Strabismus

Keywords

Postoperative delirium, Sleep quality, Pediatric anesthesia, 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Years to 12 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Any underlying diseases * Disagree

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results