The Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery
Not Applicable
Not yet recruiting
- Conditions
- Emergence Delirium
- Registration Number
- NCT05883280
- Lead Sponsor
- Seoul National University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 74
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of emergence delirium in postanesthetic care unit (PACU) within 1hr after the end of surgery
- Secondary Outcome Measures
Name Time Method 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) alpha, beta, gamma, delta, slow wave power and their ratio
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie binaural beat effects on emergence delirium in pediatric strabismus surgery?
How does binaural beat intervention compare to standard-of-care for emergence agitation in children undergoing strabismus procedures?
Are there specific biomarkers that predict response to alpha frequency binaural beats in reducing post-anesthesia delirium in pediatrics?
What are the potential adverse events associated with alpha frequency binaural beat therapy in pediatric anesthesia settings?
What combination approaches or alternative therapies are being explored alongside binaural beats for managing emergence delirium in children?
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital🇰🇷Seoul, Korea, Republic of