The Effect of Intraoperative Binaural Beats on Remimazolam Dose Required for Maintenance of General Anesthesia

Seoul National University

Status: Not yet enrolling

Conditions: Breast Reconstruction

Treatments: Device: control; Device: biaural beat

Study type: Interventional

Funder types: Other

Identifiers

NCT07311642

2510-082-1686

Details and patient eligibility

About

This prospective randomized controlled trial evaluates whether intraoperative binaural beats reduce the remimazolam dose required for general anesthesia in 88 adults undergoing breast surgery. Patients are assigned to binaural beats or silent earphones, and the primary outcome is total intraoperative remimazolam consumption.

Enrollment: 88 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (≥19 years old) scheduled to undergo breast surgery with reconstruction under general anesthesia.

Exclusion criteria

• Patients with hearing impairment, hearing loss, or those using hearing aids
• Patients with external auditory canal disease that prevents wearing earphones
• Patients with chronic use of hypnotics or sedatives
• Patients with a history of obstructive sleep apnea or a BMI ≥ 35 kg/m²
• Patients with alcohol dependence or substance abuse
• Patients deemed inappropriate for study participation at the discretion of the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

biaural beat

Experimental group

Description:

Participants receive binaural beats via earphones from OR entry until end of surgery.

Treatment:

Device: biaural beat

control

Active Comparator group

Description:

Participants wear identical earphones but receive no audio stimulation.

Treatment:

Device: control