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

NCT07311642 | Not Yet Recruiting

• 1 other identifier: 2510-082-1686
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

• Total intraoperative remimazolam dose

  Total amount of remimazolam administered during general anesthesia

  From induction of anesthesia to end of surgery

Secondary Outcomes (7)

• Total intraoperative remifentanil dose

  Intraoperative period

• BIS

  Intraoperative period

• Postoperative analgesic use

  PACU until Postoperative day 1

• Heart rate

  intraoperative

• blood pressure

  intraoperative

Study Arms (2)

biaural beat

EXPERIMENTAL

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

Device: biaural beat

control

ACTIVE COMPARATOR

Participants wear identical earphones but receive no audio stimulation.

Device: control

Interventions

control DEVICE

Participants wear identical earphones but receive no audio stimulation.

control

biaural beat DEVICE

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

biaural beat

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Design

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

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 31, 2025
• Study Start: January 31, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-11