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

NCT03332407 | Completed

• 1 other identifier: 2017-1022
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Delirium; Strabismus; Sleep Disorder

Keywords

Postoperative delirium; Sleep quality; Pediatric anesthesia; Strabismus surgery

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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.

  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.

  1 day after the surgery ( < 24 hours )

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Subject of this study is pediatric patients aged 4\~12 years, undergoing elective strabismus surgery.

You may qualify if:

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

You may not qualify if:

• Any underlying diseases
• Disagree

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan national university hospital

Busan, South Korea

Location

Related Publications (1)

• 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.

  PMID: 34809579 DERIVED

MeSH Terms

Conditions

Emergence Delirium; Strabismus; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Ocular Motility Disorders; Cranial Nerve Diseases; Eye Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: October 22, 2017
• First Posted: November 6, 2017
• Study Start: May 2, 2017
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)