Anesthesia, GeneralBSNCT05431881
Binaural Sound Effects for General Anesthesia
A study testing Binaural beat and Silent in people with Anesthesia, General, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
30 minutes before entering the operating room, the anxiety score is evaluated using a visual analogue scale (VAS) score, and stereo headphones, which can transmit binaural beat, are put on. According to a computer-generated assignment table, subjects are divided into an experimental group and a control group. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- Binaural beat and Silent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jul 2022to 7 Oct 2023
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged 20-50 who require general anesthesia
- Patients who are able to provide written consent to participate in the clinical trial, to understand the procedure of this clinical trial, and to fill out the questionnaire appropriately
- Patients with ASA physical status classification 1-2
- Patients weighing from 50 kg to 80 kg
Who cannot join
- Patients with hearing loss or using hearing aids
- Patients who received narcotic analgesics or sedative drugs within 1 week
- Patients with alcohol or drug dependence
- Patients with drug hypersensitivity to propofol
- Patients with arrhythmia, cardiovascular disease, and decreased heart function
- Patients with liver failure
- Patients who are judged to be inappropriate for this clinical trial according to the opinions of investigators
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Jeong-Hwa Seo, MD, Ph D, 82-2-2072-0641, eongpa@empas.com
About this study
Official title: The Effect of Preoperative Binaural Sound on Propofol Dose Required for Induction of General Anesthesia: a Randomized, Placebo-controlled Trial
30 minutes before entering the operating room, the anxiety score is evaluated using a visual analogue scale (VAS) score, and stereo headphones, which can transmit binaural beat, are put on. According to a computer-generated assignment table, subjects are divided into an experimental group and a control group.
Binaural beat is applied to the experimental group for 20 minutes, and a silent state is applied to the control group for 20 minutes. After entering the operating room, electrocardiogram, pulse oxymetry, non-invasive blood pressure monitor, and sensor for depth of anesthsia are attached. Before induction of anesthesia, the anxiety score is evaluated on a VAS, again.
For anesthesia induction, propofol is administered at a rate of 10 mg every 15 seconds over 5 seconds. Assess the amount of propofol administered until the response to voice ("Open your eyes.") is absent, the subject's eyelash reflex disappears, and the PSI reaches below 50. Discontinue propofol injection when all three assessments (unresponsiveness to voice, loss of eyelash reflexes, Patient Sate Index (PSI) ≤ 50) become positive.
Read the detailed description
30 minutes before entering the operating room, anxiety is evaluated on a VAS score (0-100mm, a ruler without scale) and stereo headphones, which can transmit binaural beat, are put on. A third party unrelated to the experiment sees the randomization table and applies binaural sound to the experimental group and silent state (silent sound file) to the control group for 20 minutes.
The sound generator is a smartphone device, which is hung on the transport bed. The volume is set to a level corresponding to 60dB.
After entering the operating room, start monitoring vital signs and depth of anesthesia (PSI) by attaching an electrocardiogram, pulse oxymetry, non-invasive blood pressure monitor, and sedline. Prepare by connecting a 3-way at the most proximal part of the intravenous cannula. After changing the volume to 0, take off the headphones, and evaluate the anxiety score using VAS.
Preoxygenation with oxygen 8L/min is sufficient, and in order to reduce venous pain caused by propofol injection, 1% lidocaine 50mg is pre-administrated. For anesthesia induction, 10mg propofol is administered every 15 seconds for 5 seconds. Assess the amount and time of propofol administered until the response to the voice ("Open your eyes.") is absent, the patient's eyelash reflex disappears, and the PSI reaches below 50. Propofol is administered until all three evaluations (no response to voice, loss of eyelash reflexes, PSI ≤ 50) are positive. After that, propofol is not administered. During anesthesia induction, the concentration of the inhaled anesthetic is adjusted so that Psi is between 25-50, and the anesthesia process is the same for both groups.
Continuously monitor blood pressure, pulse, and Psi, and record the MAC value of the inhaled anesthetic immediately after tracheal intubation, vital signs, and Psi.
The raw data of EEG is stored through the Sedline sensor and additionally analyzed and evaluated. The primary endpoint is the dose of propofol administered until the response to the voice ("Open your eyes.") is absent
- Conditions
- Anesthesia, General
- Being tested
- Binaural beat, Silent
- Keywords
- Propofol, Brain Waves
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binaural beatProcedure or surgery
Different frequencies are transmitted in both ears, causing beats. The low frequency sound generated by beats induces brainwaves entrainment.
SilentProcedure or surgery
Apply a wave file which is created in silence.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | A silent state (a wave file made without sound) is applied for at least 20 minutes from 20 minutes before arrival to the operating room. The sound generator is a smartphone device, set the volume (at a volume corresponding to 60 dB in the experimental group), and hang it on the transport bed. Upon arrival in the operating room, before anesthesia, the volume is adjusted to 0. Receives: Procedure: Silent |
| Binaural beat | Experimental | In the experimental group, the binaural sound, which was produced by the beat of 2Hz difference, is applied for 20 minutes from 20 minutes before arrival to the operating room. The sound generator is a smartphone device, set the volume corresponding to 60 dB, and hang it on the transport bed. Upon arrival in the operating room, before anesthesia, the volume is adjusted to 0. Receives: Procedure: Binaural beat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol dose
The amount of propofol administered until the response to the voice ("Open your eyes.") becomes absent
Measured: Until the response to the voice ("Open your eyes.") becomes absent (up to 5minutes)
Secondary outcomes (5)
Propofol dose
Propofol dose administered until eyelash reflex disappears
Measured: until eyelash reflex disappears (up to 5minutes)
Propofol dose
Propofol dose administered until PSI falls below 50
Measured: until PSI falls below 50 (up to 5minutes)
Anxiety
Anxiety is evaluated using VAS score(0-100mm ruler without a scale), 20minutes before the entrance to the operating room
Measured: 20minutes before the entrance to the operating room
Anxiety
Anxiety is evaluated using VAS score(0-100mm ruler without a scale), just before induction of anesthesia
Measured: just before induction of anesthesia
Brainwaves
brainwaves (raw data) which are collected in the Sedline device
Measured: From the time you enter the operation room until the anesthesia induction is complete (up to 30minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start5 Jul 2022
- Primary completion7 Sep 2023 (estimated)
- Study completion7 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, GeneralStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective randomized study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 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
- Investigators
- Jeong-Hwa Seo, MD.,PhD., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431881
- Sponsor's protocol ID
- 2204-007-1313
- Acronym
- BS
- Status last verified
- Aug 2023
- First submitted
- 9 Jun 2022
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schmid W, Marhofer P, Opfermann P, Zadrazil M, Kimberger O, Triffterer L, Marhofer D, Klug W. Brainwave entrainment to minimise sedative drug doses in paediatric surgery: a randomised controlled trial. Br J Anaesth. 2020 Sep;125(3):330-335. doi: 10.1016/j.bja.2020.05.050. Epub 2020 Jul 8.
PubMed 32653082Turkistani A, Abdullah KM, Al-Shaer AA, Mazen KF, Alkatheri K. Melatonin premedication and the induction dose of propofol. Eur J Anaesthesiol. 2007 May;24(5):399-402. doi: 10.1017/S0265021506001505. Epub 2006 Nov 10.
PubMed 17094871Facco E, Stellini E, Bacci C, Manani G, Pavan C, Cavallin F, Zanette G. Validation of visual analogue scale for anxiety (VAS-A) in preanesthesia evaluation. Minerva Anestesiol. 2013 Dec;79(12):1389-95. Epub 2013 Jul 9.
PubMed 23860442Padmanabhan R, Hildreth AJ, Laws D. A prospective, randomised, controlled study examining binaural beat audio and pre-operative anxiety in patients undergoing general anaesthesia for day case surgery. Anaesthesia. 2005 Sep;60(9):874-7. doi: 10.1111/j.1365-2044.2005.04287.x.
PubMed 16115248Kim YJ, Choe HW, Yoon SB, Lee H, Kim HS, Seo JH. Effects of preoperative binaural beats on the propofol dose for induction of general anesthesia: a randomized controlled trial. Can J Anaesth. 2025 Jul;72(7):1101-1109. doi: 10.1007/s12630-025-02993-5. Epub 2025 Jun 25.
PubMed 40563070
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Binaural Sound on Propofol Dose Required for Induction of General Anesthesia: a Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05431881
- Acronym / sponsor ID
- BS / 2204-007-1313
- Conditions
- Anesthesia, General
- Keywords
- Propofol, Brain Waves
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 7 Sep 2023 (estimated)
- Study completion
- 7 Oct 2023 (estimated)
- First posted
- 24 Jun 2022 (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.
30 minutes before entering the operating room, the anxiety score is evaluated using a visual analogue scale (VAS) score, and stereo headphones, which can transmit binaural beat, are put on. According to a computer-generated assignment table, subjects are divided into an experimental group and a control group.
Binaural beat is applied to the experimental group for 20 minutes, and a silent state is applied to the control group for 20 minutes. After entering the operating room, electrocardiogram, pulse oxymetry, non-invasive blood pressure monitor, and sensor for depth of anesthsia are attached. Before induction of anesthesia, the anxiety score is evaluated on a VAS, again.
For anesthesia induction, propofol is administered at a rate of 10 mg every 15 seconds over 5 seconds. Assess the amount of propofol administered until the response to voice ("Open your eyes.") is absent, the subject's eyelash reflex disappears, and the PSI reaches below 50. Discontinue propofol injection when all three assessments (unresponsiveness to voice, loss of eyelash reflexes, Patient Sate Index (PSI) ≤ 50) become positive.
Detailed description
30 minutes before entering the operating room, anxiety is evaluated on a VAS score (0-100mm, a ruler without scale) and stereo headphones, which can transmit binaural beat, are put on. A third party unrelated to the experiment sees the randomization table and applies binaural sound to the experimental group and silent state (silent sound file) to the control group for 20 minutes.
The sound generator is a smartphone device, which is hung on the transport bed. The volume is set to a level corresponding to 60dB.
After entering the operating room, start monitoring vital signs and depth of anesthesia (PSI) by attaching an electrocardiogram, pulse oxymetry, non-invasive blood pressure monitor, and sedline. Prepare by connecting a 3-way at the most proximal part of the intravenous cannula. After changing the volume to 0, take off the headphones, and evaluate the anxiety score using VAS.
Preoxygenation with oxygen 8L/min is sufficient, and in order to reduce venous pain caused by propofol injection, 1% lidocaine 50mg is pre-administrated. For anesthesia induction, 10mg propofol is administered every 15 seconds for 5 seconds. Assess the amount and time of propofol administered until the response to the voice ("Open your eyes.") is absent, the patient's eyelash reflex disappears, and the PSI reaches below 50. Propofol is administered until all three evaluations (no response to voice, loss of eyelash reflexes, PSI ≤ 50) are positive. After that, propofol is not administered. During anesthesia induction, the concentration of the inhaled anesthetic is adjusted so that Psi is between 25-50, and the anesthesia process is the same for both groups.
Continuously monitor blood pressure, pulse, and Psi, and record the MAC value of the inhaled anesthetic immediately after tracheal intubation, vital signs, and Psi.
The raw data of EEG is stored through the Sedline sensor and additionally analyzed and evaluated. The primary endpoint is the dose of propofol administered until the response to the voice ("Open your eyes.") is absent
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective randomized study
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Procedure: SilentA silent state (a wave file made without sound) is applied for at least 20 minutes from 20 minutes before arrival to the operating room. The sound generator is a smartphone device, set the volume (at a volume corresponding to 60 dB in the experimental group), and hang it on the transport bed. Upon arrival in the operating room, before anesthesia, the volume is adjusted to 0. |
| Binaural beat | Experimental | Procedure: Binaural beatIn the experimental group, the binaural sound, which was produced by the beat of 2Hz difference, is applied for 20 minutes from 20 minutes before arrival to the operating room. The sound generator is a smartphone device, set the volume corresponding to 60 dB, and hang it on the transport bed. Upon arrival in the operating room, before anesthesia, the volume is adjusted to 0. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult patients aged 20-50 who require general anesthesia
- Patients who are able to provide written consent to participate in the clinical trial, to understand the procedure of this clinical trial, and to fill out the questionnaire appropriately
- Patients with ASA physical status classification 1-2
- Patients weighing from 50 kg to 80 kg
Key exclusion criteria (7 listed)
- Patients with hearing loss or using hearing aids
- Patients who received narcotic analgesics or sedative drugs within 1 week
- Patients with alcohol or drug dependence
- Patients with drug hypersensitivity to propofol
- Patients with arrhythmia, cardiovascular disease, and decreased heart function
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 beatDifferent frequencies are transmitted in both ears, causing beats. The low frequency sound generated by beats induces brainwaves entrainment. | Procedure or surgery | Binaural beat |
| SilentApply a wave file which is created in silence. | Procedure or surgery | Control |
Primary outcome
Propofol dose
Time frame: Until the response to the voice ("Open your eyes.") becomes absent (up to 5minutes)
The amount of propofol administered until the response to the voice ("Open your eyes.") becomes absent
5 secondary outcomes
Propofol dose
Time frame: until eyelash reflex disappears (up to 5minutes)
Propofol dose
Time frame: until PSI falls below 50 (up to 5minutes)
Anxiety
Time frame: 20minutes before the entrance to the operating room
Anxiety
Time frame: just before induction of anesthesia
Brainwaves
Time frame: From the time you enter the operation room until the anesthesia induction is complete (up to 30minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Background: PubMed 32653082Schmid W, Marhofer P, Opfermann P, Zadrazil M, Kimberger O, Triffterer L, Marhofer D, Klug W. Brainwave entrainment to minimise sedative drug doses in paediatric surgery: a randomised controlled trial. Br J Anaesth. 2020 Sep;125(3):330-335. doi: 10.1016/j.bja.2020.05.050. Epub 2020 Jul 8.
- Background: PubMed 17094871Turkistani A, Abdullah KM, Al-Shaer AA, Mazen KF, Alkatheri K. Melatonin premedication and the induction dose of propofol. Eur J Anaesthesiol. 2007 May;24(5):399-402. doi: 10.1017/S0265021506001505. Epub 2006 Nov 10.
- Background: PubMed 23860442Facco E, Stellini E, Bacci C, Manani G, Pavan C, Cavallin F, Zanette G. Validation of visual analogue scale for anxiety (VAS-A) in preanesthesia evaluation. Minerva Anestesiol. 2013 Dec;79(12):1389-95. Epub 2013 Jul 9.
- Background: PubMed 16115248Padmanabhan R, Hildreth AJ, Laws D. A prospective, randomised, controlled study examining binaural beat audio and pre-operative anxiety in patients undergoing general anaesthesia for day case surgery. Anaesthesia. 2005 Sep;60(9):874-7. doi: 10.1111/j.1365-2044.2005.04287.x.
- Derived from this study: PubMed 40563070Kim YJ, Choe HW, Yoon SB, Lee H, Kim HS, Seo JH. Effects of preoperative binaural beats on the propofol dose for induction of general anesthesia: a randomized controlled trial. Can J Anaesth. 2025 Jul;72(7):1101-1109. doi: 10.1007/s12630-025-02993-5. Epub 2025 Jun 25.
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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.
Jeong-Hwa Seo, MD.,PhD. principal investigator
Seoul National University Hospital
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 beat and Silent in people with Anesthesia, General, run by Seoul National University 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 7 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 15 Aug 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 Jeong-Hwa Seo, MD.,PhD. (+82-10-55020551, eongpa@empas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propofol dose (time frame: Until the response to the voice ("Open your eyes.") becomes absent (up to 5minutes)). 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 NCT05431881, which also lists 5 linked publications.
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 15 Aug 2023.