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

Seoul National University

Status: Not yet enrolling

Conditions: General Anesthesia; Children

Treatments: Other: Application of Binarual Beat

Study type: Interventional

Funder types: Other

Identifiers

NCT06979206

2501-127-1610

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: All

Ages: Under 3 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups

Binarual beat group

Experimental group

Description:

In this group, a binaural beat audio file is applied throughout the maintenance of anesthesia. The binaural beat 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. Anesthesia is maintained with sevoflurane, and its concentration is adjusted to maintain a Patient State Index (PSI; SEDLine®; Masimo Corp., Irvine, USA) between 20 and 50. At the end of surgery, sevoflurane administration is discontinued, and ondansetron 0.1 mg/kg, acetaminophen 15 mg/kg, ketorolac 0.5 mg/kg, and a neuromuscular reversal agent are administered to facilitate emergence from anesthesia.

Treatment:

Other: Application of Binarual Beat

Control group

No Intervention group

Description:

This group undergoes anesthesia using the conventional method, with maintenance of anesthesia achieved using sevoflurane. The concentration of sevoflurane is adjusted to maintain a Patient State Index (PSI; SEDLine®; Masimo Corp., Irvine, USA) between 20 and 50. At the end of surgery, sevoflurane administration is discontinued, and ondansetron 0.1 mg/kg, acetaminophen 15 mg/kg, ketorolac 0.5 mg/kg, and a neuromuscular reversal agent are administered to facilitate emergence from anesthesia.