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

The Effect of Intraoperative Binaural Beats on Remimazolam Dose Required for Maintenance of General Anesthesia: a Randomized, Placebo-controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Reconstruction
• Intervention / Treatment: Device: biaural beat; Device: control

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: biaural beat; Participants receive binaural beats via earphones from OR entry until end of surgery.	Device: biaural beat; Participants receive binaural beats via earphones from OR entry until end of surgery.
Active Comparator: control; Participants wear identical earphones but receive no audio stimulation.	Device: control; Participants wear identical earphones but receive no audio stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intraoperative remimazolam dose	Total amount of remimazolam administered during general anesthesia	From induction of anesthesia to end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intraoperative remifentanil dose	Total remifentanil administered using target-controlled infusion.	Intraoperative period
BIS	BIS levels measured continuously.	Intraoperative period
Postoperative analgesic use	Amount of opioids, non-opioid analgesics administered.	PACU until Postoperative day 1
Heart rate	Heart rate during operation	intraoperative
blood pressure	blood pressure during surgery	intraoperative
SpO₂	saturation during surgery	intraoperative
Postoperative antiemetic use	Amount of antiemetics administered.	PACU until Postoperative day 1

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 31, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2510-082-1686

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No