The Effect of Intraoperative Binaural Beats on Remimazola... | NCT07311642

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

NCT07311642

Sponsor

Seoul National University Hospital

Status

Not yet recruiting

Last Update Posted

Dec 31, 2025Actual

Enrollment

88Estimated

Phase

Not Applicable

Conditions

Breast Reconstruction

Interventions

biaural beat
control

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2026Estimated

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Dec 1, 2026Estimated

First Submitted Date

Dec 4, 2025

First Submission Date that Met QC Criteria

Dec 30, 2025

First Posted Date

Dec 31, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2025

Last Update Posted Date

Dec 31, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
biaural beat	Device	Participants receive binaural beats via earphones from OR entry until end of surgery.	biaural beat

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Total intraoperative remifentanil dose	Total remifentanil administered using target-controlled infusion.	Intraoperative period
BIS	BIS levels measured continuously.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided