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Clinical Trials/NCT05883280
NCT05883280
Not yet recruiting
Not Applicable

The Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery

Seoul National University Hospital1 site in 1 country74 target enrollmentMay 20, 2023
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ConditionsEmergence Delirium

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emergence Delirium
Sponsor
Seoul National University Hospital
Enrollment
74
Locations
1
Primary Endpoint
Incidence of emergence delirium in postanesthetic care unit (PACU)
Status
Not yet recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The hypothesis of this study is that providing continuous binaural beats with a phase difference in alpha frequency during anesthesia can reduce the incidence of emergence agitation in pediatric patients. To test this hypothesis, the occurrence of emergence agitation will be compared between the group that received binaural beats and the group that did not receive binaural beats.

Registry
clinicaltrials.gov
Start Date
May 20, 2023
End Date
June 20, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeong-Hwa Seo

professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • •Children under the age of 7 receiving a strabismus surgery under general anesthesia.
  • •American Society of Anesthesiologists Physical status classification 1-2.

Exclusion Criteria

  • •Pediatric patients with hearing impairment or those who are currently using a hearing aid
  • •Pediatric patients with neurological disorders
  • •Pediatric patients with respiratory disorders

Outcomes

Primary Outcomes

Incidence of emergence delirium in postanesthetic care unit (PACU)

Time Frame: within 1hr after the end of surgery

Secondary Outcomes

  • Pain score (The Face, Legs, Activity, Cry and Consolability score)(within 1hr after the end of surgery)
  • Paediatric Assessment of Emergence Delirium (PAED) score(within 1hr after the end of surgery (every 10 minutes, the score will be checked))
  • EEG analysis during emergence period(Time from discontinuation of sevoflurane to entering to PACU (within 1hr after the end of surgery))

Study Sites (1)

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