Effects of Binaural Beats on Inhaled Anesthetic Requirements During General Anesthesia in Pediatric Patients

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.

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Key information

Conditions

General Anesthesia Children

Age range

Up to 3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.).
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

Treatment and study plan

Application of Binarual Beat

Other

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.

Primary outcomes

The average EtSevo (end-tidal sevoflurane concentration, vol%) maintained during surgery.

Time frame: During surgery, more than 1 hour

Study contacts

Contact information is provided by the study sponsor or research team.

Ji-Hyun Lee, MD, PhD

CONTACT

[email protected]

+82-10-7665-8848

Ji-Hyun Lee, MD, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effects of Binaural Beats on Inhaled Anesthetic Requirements During General Anesthesia in Pediatric Patients: A Prospective, Randomized Controlled Trial

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: May 18, 2025
Registry last updated: May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed