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Not yet recruitingNCT07311642Updated Dec 31, 2025

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

An interventional study of biaural beat and control in Breast Reconstruction, sponsored by Seoul National University Hospital. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-12-31.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
19 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Breast Reconstruction
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In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
88 participants (estimated)

Study arms

  • Experimental
    biaural beat

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

    Device: biaural beat

  • Active comparator
    control

    Participants wear identical earphones but receive no audio stimulation.

    Device: control

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.

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What researchers measure

Primary outcomes

  1. Total intraoperative remimazolam dose

    Total amount of remimazolam administered during general anesthesia

    Time frame: From induction of anesthesia to end of surgery

Secondary outcomes

  1. Total intraoperative remifentanil dose

    Total remifentanil administered using target-controlled infusion.

    Time frame: Intraoperative period

  2. BIS

    BIS levels measured continuously.

    Time frame: Intraoperative period

  3. Postoperative analgesic use

    Amount of opioids, non-opioid analgesics administered.

    Time frame: PACU until Postoperative day 1

  4. Heart rate

    Heart rate during operation

    Time frame: intraoperative

  5. blood pressure

    blood pressure during surgery

    Time frame: intraoperative

  6. SpO₂

    saturation during surgery

    Time frame: intraoperative

  7. Postoperative antiemetic use

    Amount of antiemetics administered.

    Time frame: PACU until Postoperative day 1

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07311642
Lead sponsor
Seoul National University Hospital
Responsible party
Jeong-Hwa Seo (Professor, Seoul National University Hospital) — Principal investigator
First posted
Dec 31, 2025
Start date
Jan 31, 2026 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Dec 31, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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