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NCT Number: NCT07311642

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

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.

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Key information

Conditions

Breast Reconstruction

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biaural beat

Device

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

Control

Device

Participants wear identical earphones but receive no audio stimulation.

Primary outcomes

  1. Total intraoperative remimazolam dose

    Time frame: From induction of anesthesia to end of surgery

    Total amount of remimazolam administered during general anesthesia

Secondary outcomes

  1. Total intraoperative remifentanil dose

    Time frame: Intraoperative period

    Total remifentanil administered using target-controlled infusion.

  2. BIS

    Time frame: Intraoperative period

    BIS levels measured continuously.

  3. Postoperative analgesic use

    Time frame: PACU until Postoperative day 1

    Amount of opioids, non-opioid analgesics administered.

  4. Heart rate

    Time frame: intraoperative

    Heart rate during operation

  5. blood pressure

    Time frame: intraoperative

    blood pressure during surgery

  6. SpO₂

    Time frame: intraoperative

    saturation during surgery

  7. Postoperative antiemetic use

    Time frame: PACU until Postoperative day 1

    Amount of antiemetics administered.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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