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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07311642

Enrollment

Registered

2025-12-31

Start date

2026-01-31

Completion date

2026-12-01

Last updated

2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Reconstruction

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.

Interventions

DEVICEbiaural beat

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

DEVICEcontrol

Participants wear identical earphones but receive no audio stimulation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026