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

NCT06979206 | Not Yet Recruiting DMC

• 1 other identifier: 2501-127-1610
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

General Anesthesia; Children

Outcome Measures

Primary Outcomes (1)

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

  During surgery, more than 1 hour

Study Arms (2)

Binarual beat group

EXPERIMENTAL

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.

Other: Application of Binarual Beat

Control group

NO INTERVENTION

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.

Interventions

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.

Binarual beat group

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Central Study Contacts

Ji-Hyun Lee, MD, PhD

CONTACT

+82-10-7665-8848; muslab6@snu.ac.kr

Ji-Hyun Lee, MD, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 18, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 21, 2025

Record last verified: 2025-05