Effect of Binaural Beats for Maintenance of General Anesthesia

Anesthesia, General Clinical Trial

— BB  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06002568
• Other study ID #: 2306-028-1437
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: July 2023
• Source: Seoul National University Hospital
• Contact: Jeong-Hwa Seo, MD., PhD.
• Phone: +82-10-55020551
• Email: eongpa[@]empas.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 122
• Est. completion date: July 31, 2025
• Est. primary completion date: July 29, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Procedure:
• Silent
Apply wave file created in silence.
• Binaural beats
Apply wave file which is intended to generate binaural beats by applying waves of different frequency (1Hz difference) in each ear.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Torri G. Inhalation anesthetics: a review. Minerva Anestesiol. 2010 Mar;76(3):215-28. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	End tidal minimal alveolar concentration - Minimum	Minimal value of end tidal minimal alveolar concentration during maintenance of general anesthesia	From the starting of surgery to the final suture of skin
Secondary	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
Secondary	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
Secondary	Vital sign	Noninvasive blood pressure (systolic & diastolic & mean, mmHg)	From the starting to the end of general anesthesia
Secondary	Vital sign	Heart rate (bpm)	From the starting to the end of general anesthesia
Secondary	Vital sign	Saturation by pulse oximeter (%)	From the starting to the end of general anesthesia
Secondary	Brain wave	Patient state index (PSI) by Sedline device	From the starting of surgery to the final suture of skin
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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