Breast ReconstructionNCT07311642
The Effect of Intraoperative Binaural Beats on Remimazolam Dose Required for Maintenance of General Anesthesia
A study testing biaural beat in people with Breast Reconstruction, run by Seoul National University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- biaural beat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥19 years old) scheduled to undergo breast surgery with reconstruction under general anesthesia.
Who cannot join
- 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
About this study
Official title: The Effect of Intraoperative Binaural Beats on Remimazolam Dose Required for Maintenance of General Anesthesia: a Randomized, Placebo-controlled Trial
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.
- Conditions
- Breast Reconstruction
- Being tested
- biaural beat, control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biaural beatDevice
Participants receive binaural beats via earphones from OR entry until end of surgery.
controlDevice
Participants wear identical earphones but receive no audio stimulation.
| Study group | Role | What they receive |
|---|---|---|
| biaural beat | Experimental | Participants receive binaural beats via earphones from OR entry until end of surgery. Receives: Device: biaural beat |
| control | Active comparator | Participants wear identical earphones but receive no audio stimulation. Receives: Device: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intraoperative remimazolam dose
Total amount of remimazolam administered during general anesthesia
Measured: From induction of anesthesia to end of surgery
Secondary outcomes (7)
Total intraoperative remifentanil dose
Total remifentanil administered using target-controlled infusion.
Measured: Intraoperative period
BIS
BIS levels measured continuously.
Measured: Intraoperative period
Postoperative analgesic use
Amount of opioids, non-opioid analgesics administered.
Measured: PACU until Postoperative day 1
Heart rate
Heart rate during operation
Measured: intraoperative
blood pressure
blood pressure during surgery
Measured: intraoperative
SpO₂
saturation during surgery
Measured: intraoperative
Postoperative antiemetic use
Amount of antiemetics administered.
Measured: PACU until Postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start31 Jan 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong-Hwa Seo, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311642
- Sponsor's protocol ID
- 2510-082-1686
- Status last verified
- Nov 2025
- First submitted
- 4 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Binaural Beats on Remimazolam Dose Required for Maintenance of General Anesthesia: a Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07311642
- Acronym / sponsor ID
- 2510-082-1686
- Conditions
- Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biaural beat | Experimental | Device: biaural beatParticipants receive binaural beats via earphones from OR entry until end of surgery. |
| control | Active comparator | Device: controlParticipants wear identical earphones but receive no audio stimulation. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (≥19 years old) scheduled to undergo breast surgery with reconstruction under general anesthesia.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biaural beatParticipants receive binaural beats via earphones from OR entry until end of surgery. | Device | biaural beat |
| controlParticipants wear identical earphones but receive no audio stimulation. | Device | control |
Primary outcome
Total intraoperative remimazolam dose
Time frame: From induction of anesthesia to end of surgery
Total amount of remimazolam administered during general anesthesia
7 secondary outcomes
Total intraoperative remifentanil dose
Time frame: Intraoperative period
BIS
Time frame: Intraoperative period
Postoperative analgesic use
Time frame: PACU until Postoperative day 1
Heart rate
Time frame: intraoperative
blood pressure
Time frame: intraoperative
SpO₂
Time frame: intraoperative
Postoperative antiemetic use
Time frame: PACU until Postoperative day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing biaural beat in people with Breast Reconstruction, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total intraoperative remimazolam dose (time frame: From induction of anesthesia to end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.