Effect of Binaural Beats for Maintenance of General Anesthesia

NCT06002568 | Unknown

• 1 other identifier: 2306-028-1437
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, General

Keywords

Sevoflurane; Brain waves; Binaural Beats

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• End tidal minimal alveolar concentration - Maximum

  From the starting of surgery to the final suture of skin

• End tidal minimal alveolar concentration - Minimum

  From the starting of surgery to the final suture of skin

• Anxiety

  Right after arriving the operating room

• Anxiety

  Just before leaving the post anesthesia care unit

• Vital sign

  From the starting to the end of general anesthesia

Study Arms (2)

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.

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.

Procedure: Binaural beats

Interventions

Silent PROCEDURE

Apply wave file created in silence.

Control

Binaural beats PROCEDURE

Apply wave file which is intended to generate binaural beats by applying waves of different frequency (1Hz difference) in each ear.

Binaural Beat

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related 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.

  PMID: 16571982 BACKGROUND

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

  PMID: 20203550 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.

  PMID: 36084424 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.

  PMID: 27752068 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.

  PMID: 36421228 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.

  PMID: 19293700 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.

  PMID: 22801049 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.

  PMID: 34013463 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.

  PMID: 16115248 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.

  PMID: 27740618 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.

  PMID: 36371942 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.

  PMID: 32653082 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.

  PMID: 23860442 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.

  PMID: 35772250 BACKGROUND

Study Officials

• Jeong-Hwa Seo, MD., PhD.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeong-Hwa Seo, MD., PhD.

CONTACT

+82-10-55020551; eongpa@empas.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective randomized, placebo-controlled trial

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 21, 2023
• Study Start: August 1, 2023
• Primary Completion: July 29, 2025
• Study Completion: July 31, 2025
• Last Updated: August 21, 2023

Record last verified: 2023-07

Locations

KR (1)