Anesthesia, GeneralBBNCT06002568
Effect of Binaural Beats for Maintenance of General Anesthesia
A study testing Silent and Binaural beats in people with Anesthesia, General, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to learn about the effects of binaural beats on maintenance of general anesthesia in patients undergoing thyroidectomy without intraoperative neuromonitoring. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, General
- What is being tested?
- Silent and Binaural beats
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2023to 31 Jul 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who are scheduled for thyroidectomy without neuromonitoring
- Patients aged 20-60 who require general anesthesia over 2 hours
- 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
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 sevoflurane
- Patients with family history or past history of malignant hyperthermia
- Patients with neuromuscular disease of myasthenia gravis
Show all 9Show fewer
- Patients with arrhythmia, cardiovascular disease, and decreased heart function
- Patients with kidney 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.
About this study
Official title: ) The Effect of Intraoperative Binaural Beats on the Quantity of Inhaled Anesthetic Gas Required for the Maintenance of General Anesthesia: a Randomized, Placebo Controlled Trial
The goal of this clinical trial is to learn about the effects of binaural beats on maintenance of general anesthesia in patients undergoing thyroidectomy without intraoperative neuromonitoring.
The main question it aims to answer is:
Read more
- 1) Does applying binaural beats during surgery reduce the gas anesthetics (especially sevoflurane) requirement to maintaining adequate anesthetic depth during general anesthesia?
- 2) Does applying binaural beats during surgery affect intraoperative hemodynamic stability or post operative nausea and vomiting?
Participants will wear headsets with a sound generator which contains music files (binaural beat file in the intervention group (BB) ; silent file in control group (C)) according to the randomization. Researchers will compare the BB and C group to see if intraoperative binaural beats reduce the requirements of sevoflurane for maintaining adequate anesthetic depth.
Read the detailed description
This study will look at thyroidectomy patients without neuromonitoring. Before entering the operating room, patients will be randomized according to the randomization table, with the test group receiving a sound generating device with a binaural sound file and the control group receiving a sound generating device with a silent file. After entering the operating room, electrocardiogram, pulse oxymetry, non-invasive blood pressure monitor, and sensor for depth of anesthesia will be attached. At the beginning of anesthesia induction, the headset will be placed on the patient and a sound generator will be connected to the headset to play the file. The induction of anesthesia will be done with administration of fentanyl and propofol in both groups, and after confirming that the patient is unresponsive to voice, rocuronium and sevoflurane will be administrated to the patient. During the operation, the inhaled anesthetic concentration will be adjusted to maintain a patient state index (PSI) between 25 and 50. Fentanyl can be titrated up to 100 mcg to account for the hemodynamic response to intraoperative pain, and neuromuscular blocking agents are titrated to maintain a train of four (TOF) count of 1-3. The headset is continuously applied to the patient during surgery, and blood pressure, pulse oximetry, PSI, end tidal sevoflurane and end tidal minimal alveolar concentration will be monitored during the operation. At the time of the final suture of the skin, the sound generator will be removed from the headset. Save the raw EEG data from the Sedline® sensor for further analytical evaluation.
- Conditions
- Anesthesia, General
- Being tested
- Silent, Binaural beats
- Keywords
- Sevoflurane, Brain waves, Binaural Beats
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilentProcedure or surgery
Apply wave file created in silence.
Binaural beatsProcedure or surgery
Apply wave file which is intended to generate binaural beats by applying waves of different frequency (1Hz difference) in each ear.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | In the control group, a silent state (a wave file made without sound) is applied via the sound generator and a headset, at the starting of general anesthesia induction. The sound generator volume is set to 60 dB. The sound generator and the headset is assigned after the randomization, and is blinded to the patient and the investigator. This sound is applied during the operation, and at the time of the final skin suture, the sound generator and the headset will be removed from the patient. Receives: Procedure: Silent |
| Binaural Beat | Experimental | In the experimental group, the binaural beat which is produced by the beat of 1Hz difference is applied via the sound generator and a headset, at the starting of general anesthesia induction. The sound generator volume is set to 60 dB. The sound generator and the headset is assigned after the randomization, and is blinded to the patient and the investigator. This sound is applied during the operation, and at the time of the final skin suture, the sound generator and the headset will be removed from the patient. Receives: Procedure: Binaural beats |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average end tidal sevoflurane concentration
Average end tidal sevoflurane concentrations required for maintenance of general anesthesia from surgical incision to skin closure
Measured: From the starting of surgery to the final suture of skin
Secondary outcomes (15)
End tidal minimal alveolar concentration - Maximum
Maximal value of end tidal minimal alveolar concentration during maintenance of general anesthesia
Measured: From the starting of surgery to the final suture of skin
End tidal minimal alveolar concentration - Minimum
Minimal value of end tidal minimal alveolar concentration during maintenance of general anesthesia
Measured: From the starting of surgery to the final suture of skin
Anxiety
Anxiety is evaluated using visual analogue score(0-100mm ruler without a scale), after entering the operating room
Measured: Right after arriving the operating room
Anxiety
Anxiety is evaluated using visual analogue score(0-100mm ruler without a scale), just before leaving the post anesthesia care unit
Measured: Just before leaving the post anesthesia care unit
Vital sign
Noninvasive blood pressure (systolic \& diastolic \& mean, mmHg)
Measured: From the starting to the end of general anesthesia
Vital sign
Heart rate (bpm)
Measured: From the starting to the end of general anesthesia
Vital sign
Saturation by pulse oximeter (%)
Measured: From the starting to the end of general anesthesia
Brain wave
Patient state index (PSI) by Sedline device
Measured: From the starting of surgery to the final suture of skin
Brain wave
brainwaves (raw data) which are collected in the Sedline device - alpha, beta, theta, delta, gamma brain wave
Measured: From the starting of surgery to the final suture of skin
Post operative nausea vomiting
The incidence of post operative nausea vomiting, in the post anesthesia care unit
Measured: During the patients stay in post anesthesia care unit
Post operative nausea vomiting
The incidence of post operative nausea vomiting, in the ward within 24 hours
Measured: Since the patient leaves the post anesthesia care unit, until post operative 24 hours
Post operative pain
Pain is evaluate in Numerical rating scales score (0-10, 0 for no pain and 10 for for worst pain imaginable), in the post anesthesia care unit
Measured: While the patient stay in post anesthesia care unit
Post operative pain
Pain is evaluate in Numerical rating scales score (0-10, 0 for no pain and 10 for for worst pain imaginable), 24 hours after operation
Measured: 24 hours after operation
Delirium
The incidence of delirium in the ward within 24 hours after operation
Measured: Since the patient leaves the post anesthesia care unit, until post operative 24 hours
Delirium
The incidence of delirium in the ward within 48 hours after operation
Measured: Since the patient leaves the post anesthesia care unit, until post operative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study startAug 2023 (estimated)
- Primary completion29 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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, placebo-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeong-Hwa Seo, MD., PhD., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002568
- Sponsor's protocol ID
- 2306-028-1437
- Acronym
- BB
- Status last verified
- Jul 2023
- First submitted
- 25 Jul 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
American Society of Anesthesiologists Task Force on Intraoperative Awareness. Practice advisory for intraoperative awareness and brain function monitoring: a report by the american society of anesthesiologists task force on intraoperative awareness. Anesthesiology. 2006 Apr;104(4):847-64. doi: 10.1097/00000542-200604000-00031. No abstract available.
PubMed 16571982Torri G. Inhalation anesthetics: a review. Minerva Anestesiol. 2010 Mar;76(3):215-28.
PubMed 20203550Saller T, Hubig L, Seibold H, Schroeder Z, Wang B, Groene P, Perneczky R, von Dossow V, Hinske LC. Association between post-operative delirium and use of volatile anesthetics in the elderly: A real-world big data approach. J Clin Anesth. 2022 Dec;83:110957. doi: 10.1016/j.jclinane.2022.110957. Epub 2022 Sep 6.
PubMed 36084424Vutskits L, Xie Z. Lasting impact of general anaesthesia on the brain: mechanisms and relevance. Nat Rev Neurosci. 2016 Oct 18;17(11):705-717. doi: 10.1038/nrn.2016.128.
PubMed 27752068Ji D, Karlik J. Neurotoxic Impact of Individual Anesthetic Agents on the Developing Brain. Children (Basel). 2022 Nov 19;9(11):1779. doi: 10.3390/children9111779.
PubMed 36421228Wilder RT, Flick RP, Sprung J, Katusic SK, Barbaresi WJ, Mickelson C, Gleich SJ, Schroeder DR, Weaver AL, Warner DO. Early exposure to anesthesia and learning disabilities in a population-based birth cohort. Anesthesiology. 2009 Apr;110(4):796-804. doi: 10.1097/01.anes.0000344728.34332.5d.
PubMed 19293700Block RI, Thomas JJ, Bayman EO, Choi JY, Kimble KK, Todd MM. Are anesthesia and surgery during infancy associated with altered academic performance during childhood? Anesthesiology. 2012 Sep;117(3):494-503. doi: 10.1097/ALN.0b013e3182644684.
PubMed 22801049Fu VX, Sleurink KJ, Janssen JC, Wijnhoven BPL, Jeekel J, Klimek M. Perception of auditory stimuli during general anesthesia and its effects on patient outcomes: a systematic review and meta-analysis. Can J Anaesth. 2021 Aug;68(8):1231-1253. doi: 10.1007/s12630-021-02015-0. Epub 2021 May 19.
PubMed 34013463Padmanabhan 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 16115248Wiwatwongwana D, Vichitvejpaisal P, Thaikruea L, Klaphajone J, Tantong A, Wiwatwongwana A; Medscape. The effect of music with and without binaural beat audio on operative anxiety in patients undergoing cataract surgery: a randomized controlled trial. Eye (Lond). 2016 Nov;30(11):1407-1414. doi: 10.1038/eye.2016.160. Epub 2016 Oct 14.
PubMed 27740618Bae J, Yoo S, Kim H, Kim Y, Kim JT, Lim YJ, Kim HS. Effect of real-time binaural music on sedation with dexmedetomidine during spinal anesthesia: A triple-arm, assessor-blind, randomized controlled trial. J Clin Anesth. 2023 Feb;84:110997. doi: 10.1016/j.jclinane.2022.110997. Epub 2022 Nov 10.
PubMed 36371942Schmid 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 32653082Facco 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 23860442Long MHY, Lim EHL, Balanza GA, Allen JC Jr, Purdon PL, Bong CL. Sevoflurane requirements during electroencephalogram (EEG)-guided vs standard anesthesia Care in Children: A randomized controlled trial. J Clin Anesth. 2022 Oct;81:110913. doi: 10.1016/j.jclinane.2022.110913. Epub 2022 Jun 27.
PubMed 35772250
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ) The Effect of Intraoperative Binaural Beats on the Quantity of Inhaled Anesthetic Gas Required for the Maintenance of General Anesthesia: a Randomized, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT06002568
- Acronym / sponsor ID
- BB / 2306-028-1437
- Conditions
- Anesthesia, General
- Keywords
- Sevoflurane, Brain waves, Binaural Beats
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- 29 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 21 Aug 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.
The goal of this clinical trial is to learn about the effects of binaural beats on maintenance of general anesthesia in patients undergoing thyroidectomy without intraoperative neuromonitoring.
The main question it aims to answer is:
- 1) Does applying binaural beats during surgery reduce the gas anesthetics (especially sevoflurane) requirement to maintaining adequate anesthetic depth during general anesthesia?
- 2) Does applying binaural beats during surgery affect intraoperative hemodynamic stability or post operative nausea and vomiting?
Participants will wear headsets with a sound generator which contains music files (binaural beat file in the intervention group (BB) ; silent file in control group (C)) according to the randomization. Researchers will compare the BB and C group to see if intraoperative binaural beats reduce the requirements of sevoflurane for maintaining adequate anesthetic depth.
Detailed description
This study will look at thyroidectomy patients without neuromonitoring. Before entering the operating room, patients will be randomized according to the randomization table, with the test group receiving a sound generating device with a binaural sound file and the control group receiving a sound generating device with a silent file. After entering the operating room, electrocardiogram, pulse oxymetry, non-invasive blood pressure monitor, and sensor for depth of anesthesia will be attached. At the beginning of anesthesia induction, the headset will be placed on the patient and a sound generator will be connected to the headset to play the file. The induction of anesthesia will be done with administration of fentanyl and propofol in both groups, and after confirming that the patient is unresponsive to voice, rocuronium and sevoflurane will be administrated to the patient. During the operation, the inhaled anesthetic concentration will be adjusted to maintain a patient state index (PSI) between 25 and 50. Fentanyl can be titrated up to 100 mcg to account for the hemodynamic response to intraoperative pain, and neuromuscular blocking agents are titrated to maintain a train of four (TOF) count of 1-3. The headset is continuously applied to the patient during surgery, and blood pressure, pulse oximetry, PSI, end tidal sevoflurane and end tidal minimal alveolar concentration will be monitored during the operation. At the time of the final suture of the skin, the sound generator will be removed from the headset. Save the raw EEG data from the Sedline® sensor for further analytical evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective randomized, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Procedure: SilentIn the control group, a silent state (a wave file made without sound) is applied via the sound generator and a headset, at the starting of general anesthesia induction. The sound generator volume is set to 60 dB. The sound generator and the headset is assigned after the randomization, and is blinded to the patient and the investigator. This sound is applied during the operation, and at the time of the final skin suture, the sound generator and the headset will be removed from the patient. |
| Binaural Beat | Experimental | Procedure: Binaural beatsIn the experimental group, the binaural beat which is produced by the beat of 1Hz difference is applied via the sound generator and a headset, at the starting of general anesthesia induction. The sound generator volume is set to 60 dB. The sound generator and the headset is assigned after the randomization, and is blinded to the patient and the investigator. This sound is applied during the operation, and at the time of the final skin suture, the sound generator and the headset will be removed from the patient. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients who are scheduled for thyroidectomy without neuromonitoring
- Patients aged 20-60 who require general anesthesia over 2 hours
- 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
Key exclusion criteria (9 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 sevoflurane
- Patients with family history or past history of malignant hyperthermia
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 |
|---|---|---|
| SilentApply wave file created in silence. | Procedure or surgery | Control |
| Binaural beatsApply wave file which is intended to generate binaural beats by applying waves of different frequency (1Hz difference) in each ear. | Procedure or surgery | Binaural Beat |
Primary outcome
Average end tidal sevoflurane concentration
Time frame: From the starting of surgery to the final suture of skin
Average end tidal sevoflurane concentrations required for maintenance of general anesthesia from surgical incision to skin closure
15 secondary outcomes
End tidal minimal alveolar concentration - Maximum
Time frame: From the starting of surgery to the final suture of skin
End tidal minimal alveolar concentration - Minimum
Time frame: From the starting of surgery to the final suture of skin
Anxiety
Time frame: Right after arriving the operating room
Anxiety
Time frame: Just before leaving the post anesthesia care unit
Vital sign
Time frame: From the starting to the end of general anesthesia
Vital sign
Time frame: From the starting to the end of general anesthesia
Vital sign
Time frame: From the starting to the end of general anesthesia
Brain wave
Time frame: From the starting of surgery to the final suture of skin
Brain wave
Time frame: From the starting of surgery to the final suture of skin
Post operative nausea vomiting
Time frame: During the patients stay in post anesthesia care unit
Post operative nausea vomiting
Time frame: Since the patient leaves the post anesthesia care unit, until post operative 24 hours
Post operative pain
Time frame: While the patient stay in post anesthesia care unit
Post operative pain
Time frame: 24 hours after operation
Delirium
Time frame: Since the patient leaves the post anesthesia care unit, until post operative 24 hours
Delirium
Time frame: Since the patient leaves the post anesthesia care unit, until post operative 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Background: PubMed 16571982American Society of Anesthesiologists Task Force on Intraoperative Awareness. Practice advisory for intraoperative awareness and brain function monitoring: a report by the american society of anesthesiologists task force on intraoperative awareness. Anesthesiology. 2006 Apr;104(4):847-64. doi: 10.1097/00000542-200604000-00031. No abstract available.
- Background: PubMed 20203550Torri G. Inhalation anesthetics: a review. Minerva Anestesiol. 2010 Mar;76(3):215-28.
- Background: PubMed 36084424Saller T, Hubig L, Seibold H, Schroeder Z, Wang B, Groene P, Perneczky R, von Dossow V, Hinske LC. Association between post-operative delirium and use of volatile anesthetics in the elderly: A real-world big data approach. J Clin Anesth. 2022 Dec;83:110957. doi: 10.1016/j.jclinane.2022.110957. Epub 2022 Sep 6.
- Background: PubMed 27752068Vutskits L, Xie Z. Lasting impact of general anaesthesia on the brain: mechanisms and relevance. Nat Rev Neurosci. 2016 Oct 18;17(11):705-717. doi: 10.1038/nrn.2016.128.
- Background: PubMed 36421228Ji D, Karlik J. Neurotoxic Impact of Individual Anesthetic Agents on the Developing Brain. Children (Basel). 2022 Nov 19;9(11):1779. doi: 10.3390/children9111779.
- Background: PubMed 19293700Wilder RT, Flick RP, Sprung J, Katusic SK, Barbaresi WJ, Mickelson C, Gleich SJ, Schroeder DR, Weaver AL, Warner DO. Early exposure to anesthesia and learning disabilities in a population-based birth cohort. Anesthesiology. 2009 Apr;110(4):796-804. doi: 10.1097/01.anes.0000344728.34332.5d.
- Background: PubMed 22801049Block RI, Thomas JJ, Bayman EO, Choi JY, Kimble KK, Todd MM. Are anesthesia and surgery during infancy associated with altered academic performance during childhood? Anesthesiology. 2012 Sep;117(3):494-503. doi: 10.1097/ALN.0b013e3182644684.
- Background: PubMed 34013463Fu VX, Sleurink KJ, Janssen JC, Wijnhoven BPL, Jeekel J, Klimek M. Perception of auditory stimuli during general anesthesia and its effects on patient outcomes: a systematic review and meta-analysis. Can J Anaesth. 2021 Aug;68(8):1231-1253. doi: 10.1007/s12630-021-02015-0. Epub 2021 May 19.
- 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.
- Background: PubMed 27740618Wiwatwongwana D, Vichitvejpaisal P, Thaikruea L, Klaphajone J, Tantong A, Wiwatwongwana A; Medscape. The effect of music with and without binaural beat audio on operative anxiety in patients undergoing cataract surgery: a randomized controlled trial. Eye (Lond). 2016 Nov;30(11):1407-1414. doi: 10.1038/eye.2016.160. Epub 2016 Oct 14.
- Background: PubMed 36371942Bae J, Yoo S, Kim H, Kim Y, Kim JT, Lim YJ, Kim HS. Effect of real-time binaural music on sedation with dexmedetomidine during spinal anesthesia: A triple-arm, assessor-blind, randomized controlled trial. J Clin Anesth. 2023 Feb;84:110997. doi: 10.1016/j.jclinane.2022.110997. Epub 2022 Nov 10.
- 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.
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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 Silent and Binaural beats 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 9 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 21 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?
Average end tidal sevoflurane concentration (time frame: From the starting of surgery to the final suture of skin). 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 NCT06002568, which also lists 14 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 21 Aug 2023.