Children, General Anesthesia
Conditions
Brief summary
The hypothesis of this study is that continuously delivering binaural beats with a phase difference corresponding to the slow-delta frequency band during anesthesia in pediatric patients can clinically and significantly reduce the required dose of the commonly used inhalational anesthetic, sevoflurane. To test this hypothesis, the study will compare the average end-tidal concentration of sevoflurane between a group exposed to continuous binaural beats (approximately 1 Hz phase difference) during surgery and a control group not exposed to such auditory stimulation.
Interventions
OTHERApplication of Binarual Beat
The binaural beat audio file consists of pure tones at 431 Hz in the left ear and 432 Hz in the right ear, delivered via earphones continuously until the end of anesthesia.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
No
Inclusion criteria
1. Pediatric patients under 3 years of age undergoing superficial surgery lasting more than 1 hour under general anesthesia (e.g., nevus excision, polydactyly/syndactyly surgery, dermoid cyst excision, thyroglossal duct cyst excision, preauricular fistula excision, inguinal hernia repair, orchiopexy, other mass excisions, strabismus surgery, etc.). 2. American Society of Anesthesiologists (ASA) physical status classification I or II.
Exclusion criteria
* Neonates or premature infants * Children with hearing impairment or currently using hearing aids * Children with neurological disorders * Children with respiratory diseases * Children undergoing neurosurgery or cardiac surgery * Other patients deemed inappropriate for inclusion in the clinical trial at the discretion of the investigator or study staff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The average EtSevo (end-tidal sevoflurane concentration, vol%) maintained during surgery. | During surgery, more than 1 hour |
Contacts
Primary ContactJi-Hyun Lee, MD, PhD
Backup ContactJi-Hyun Lee, MD, PhD
Outcome results
None listed