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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silent | Procedure | Apply wave file created in silence. |
| |
| Binaural beats |
| Measure | Description | Time Frame |
|---|---|---|
| Average end tidal sevoflurane concentration | Average end tidal sevoflurane concentrations required for maintenance of general anesthesia from surgical incision to skin closure | From the starting of surgery to the final suture of skin |
| Measure | Description | Time Frame |
|---|---|---|
| End tidal minimal alveolar concentration - Maximum | Maximal value of end tidal minimal alveolar concentration during maintenance of general anesthesia | From the starting of surgery to the final suture of skin |
| End tidal minimal alveolar concentration - Minimum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeong-Hwa Seo, MD., PhD. | Contact | +82-10-55020551 | eongpa@empas.com |
| Name | Affiliation | Role |
|---|---|---|
| Jeong-Hwa Seo, MD., PhD. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16571982 | Background | 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. | |
| 20203550 |
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A prospective randomized, placebo-controlled trial
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| Procedure |
Apply wave file which is intended to generate binaural beats by applying waves of different frequency (1Hz difference) in each ear. |
|
Minimal value of end tidal minimal alveolar concentration during maintenance of general anesthesia |
| 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 | 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 | Just before leaving the post anesthesia care unit |
| Vital sign | Noninvasive blood pressure (systolic & diastolic & mean, mmHg) | From the starting to the end of general anesthesia |
| Vital sign | Heart rate (bpm) | From the starting to the end of general anesthesia |
| Vital sign | Saturation by pulse oximeter (%) | From the starting to the end of general anesthesia |
| Brain wave | Patient state index (PSI) by Sedline device | 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 | 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 | 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 | 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 | 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 | 24 hours after operation |
| Delirium | The incidence of delirium in the ward within 24 hours after operation | 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 | Since the patient leaves the post anesthesia care unit, until post operative 48 hours |
| Torri G. Inhalation anesthetics: a review. Minerva Anestesiol. 2010 Mar;76(3):215-28. |
| 36084424 | Background | Saller 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. |
| 27752068 | Background | Vutskits 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. |
| 36421228 | Background | Ji 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. |
| 19293700 | Background | Wilder 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. |
| 22801049 | Background | Block 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. |
| 34013463 | Background | Fu 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. |
| 16115248 | Background | Padmanabhan 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. |
| 27740618 | Background | Wiwatwongwana 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. |
| 36371942 | Background | Bae 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. |
| 32653082 | Background | 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. |
| 23860442 | Background | Facco 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. |
| 35772250 | Background | Long 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. |