General AnesthesiaNCT06099977
Binaural Sound for Remimazolam Induction
A study testing Binaural sound in people with General Anesthesia and Prostate Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
It is important to decrease the time-to-loss of consciousness and anesthetics dose of remimazolam for general anesthesia induction. We will evaluate the effect of binaural sound for general anestheia induction using remimazolam infusion. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- General Anesthesia, Prostate Cancer, Uterine Myoma
- What is being tested?
- Binaural sound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2023to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for generla anesthesia
- Patients aged 20-60
- Patients with American Society of Anesthesiologist physical status classification 1-2
- Patients with ideal body weight 50-80 kg
Who cannot join
- Patients with hearing disability
- Patients using opioids or sedatives in 1 week
- Patients who are dependent for alcoholics or drugs
- Patients with hypersensitivities to remimazolam
- Patients with arrhythmia, cardiovascular disease, heart failure, or hypovolemia
- Patients with liver failure
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
GangnamSeveranceHospital
Seoul
HyunChang Kim, ONIDORI@yuhs.ac
About this study
Official title: The Effect of Preoperative Binaural Sound on Remimazolam Dose Required for Induction of General Anesthesia: a Randomized, Placebo-controlled Trial
It is important to decrease the time-to-loss of consciousness and anesthetics dose of remimazolam for general anesthesia induction. We will evaluate the effect of binaural sound for general anestheia induction using remimazolam infusion.
- Conditions
- General Anesthesia, Prostate Cancer, Uterine Myoma
- Being tested
- Binaural sound, Placebo
- Medical subject headings
- Prostatic Neoplasms, Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binaural soundProcedure or surgery
Binaural sound: Binaural sound will be applied.
PlaceboProcedure or surgery
Only headphone without sound will be applied.
| Study group | Role | What they receive |
|---|---|---|
| I (Binaural) | Experimental | Binaural sound using headphone will be applied. Receives: Procedure: Binaural sound |
| II (Placebo) | Placebo comparator | Only headphone without sound will be applied. Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remimazolam dose for no response to voice
Remimazolam dose for no response to voice will be measured at anesthesia day 0.
Measured: At anesthesia day 0
Secondary outcomes (4)
Remimazolam dose for no eye lash reflex
Remimazolam dose for no eye lash reflex will be measured at anesthesia day 0.
Measured: At anesthesia day 0
Remimazolam dose for patient state index 50
Remimazolam dose for patient state index 50 will be measured at anesthesia day 0.
Measured: At anesthesia day 0
Anxiety level
Anxiety level will be evaluated using viosual analogue scale at anesthesia day 0 (at arrival of preanesthetic room and operating room).
Measured: At anesthesia day 0
Patient state index electroencephalography
Patient state index electroencephalography will be evaluated at anesthesia day 0
Measured: At anesthesia day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Nov 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Chang Kim, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099977
- Sponsor's protocol ID
- 3-2023-0305
- Status last verified
- Nov 2023
- First submitted
- 20 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim HC, Sohn JY, Kim MH, Kim YJ, Chang CH, Seo JH. Preoperative binaural beats reduce remimazolam dosage and enhance safety in anesthesia induction: A randomized controlled trial. PLoS One. 2026 Mar 30;21(3):e0345960. doi: 10.1371/journal.pone.0345960. eCollection 2026.
PubMed 41911215
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Binaural Sound on Remimazolam Dose Required for Induction of General Anesthesia: a Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06099977
- Acronym / sponsor ID
- 3-2023-0305
- Conditions
- General Anesthesia, Prostate Cancer, Uterine Myoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 25 Oct 2023 (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.
It is important to decrease the time-to-loss of consciousness and anesthetics dose of remimazolam for general anesthesia induction. We will evaluate the effect of binaural sound for general anestheia induction using remimazolam infusion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I (Binaural) | Experimental | Procedure: Binaural soundBinaural sound using headphone will be applied. |
| II (Placebo) | Placebo comparator | Procedure: PlaceboOnly headphone without sound will be applied. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for generla anesthesia
- Patients aged 20-60
- Patients with American Society of Anesthesiologist physical status classification 1-2
- Patients with ideal body weight 50-80 kg
Key exclusion criteria (6 listed)
- Patients with hearing disability
- Patients using opioids or sedatives in 1 week
- Patients who are dependent for alcoholics or drugs
- Patients with hypersensitivities to remimazolam
- Patients with arrhythmia, cardiovascular disease, heart failure, or hypovolemia
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 |
|---|---|---|
| Binaural soundBinaural sound: Binaural sound will be applied. | Procedure or surgery | I (Binaural) |
| PlaceboOnly headphone without sound will be applied. | Procedure or surgery | II (Placebo) |
Primary outcome
Remimazolam dose for no response to voice
Time frame: At anesthesia day 0
Remimazolam dose for no response to voice will be measured at anesthesia day 0.
4 secondary outcomes
Remimazolam dose for no eye lash reflex
Time frame: At anesthesia day 0
Remimazolam dose for patient state index 50
Time frame: At anesthesia day 0
Anxiety level
Time frame: At anesthesia day 0
Patient state index electroencephalography
Time frame: At anesthesia day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 41911215Kim HC, Sohn JY, Kim MH, Kim YJ, Chang CH, Seo JH. Preoperative binaural beats reduce remimazolam dosage and enhance safety in anesthesia induction: A randomized controlled trial. PLoS One. 2026 Mar 30;21(3):e0345960. doi: 10.1371/journal.pone.0345960. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binaural sound in people with General Anesthesia and Prostate Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
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 4 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun-Chang Kim (82-2-2224-3919, onidori@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remimazolam dose for no response to voice (time frame: At anesthesia day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06099977, which also lists 1 linked publication.
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 18 Nov 2023.