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

NCT ID: NCT07311642

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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biaural beat

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

Group Type EXPERIMENTAL

biaural beat

Intervention Type DEVICE

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

control

Participants wear identical earphones but receive no audio stimulation.

Group Type ACTIVE_COMPARATOR

control

Intervention Type DEVICE

Participants wear identical earphones but receive no audio stimulation.

Interventions

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biaural beat

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

Intervention Type DEVICE

control

Participants wear identical earphones but receive no audio stimulation.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong-Hwa Seo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2510-082-1686

Identifier Type: -

Identifier Source: org_study_id