Brief 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. 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Jul 2022

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

June 9, 2022

Completed

15 days until next milestone

First Posted

Study publicly available on registry

June 24, 2022

Completed

11 days until next milestone

Study Start

First participant enrolled

July 5, 2022

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2023

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2023

Completed

Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

1.2 years

First QC Date

June 9, 2022

Last Update Submit

August 11, 2023

Conditions

Anesthesia, General

Keywords

PropofolBrain Waves

Outcome Measures

Primary Outcomes (1)

Propofol dose
The amount of propofol administered until the response to the voice ("Open your eyes.") becomes absent
Until the response to the voice ("Open your eyes.") becomes absent (up to 5minutes)

Secondary Outcomes (5)

Propofol dose
until eyelash reflex disappears (up to 5minutes)
Propofol dose
until PSI falls below 50 (up to 5minutes)
Anxiety
20minutes before the entrance to the operating room
Anxiety
just before induction of anesthesia
Brainwaves
From the time you enter the operation room until the anesthesia induction is complete (up to 30minutes)

Study Arms (2)

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.

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.

Procedure: Binaural beat

Interventions

Binaural beatPROCEDURE

Different frequencies are transmitted in both ears, causing beats. The low frequency sound generated by beats induces brainwaves entrainment.

Binaural beat

SilentPROCEDURE

Apply a wave file which is created in silence.

Control

Eligibility Criteria

Age20 Years - 50 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

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

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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Seoul National University Hospitallead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (5)

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: 32653082BACKGROUND
Turkistani 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.
PMID: 17094871BACKGROUND
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: 23860442BACKGROUND
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: 16115248BACKGROUND
Kim 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.
PMID: 40563070DERIVED

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: DOUBLE
Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

June 9, 2022

First Posted

June 24, 2022

Study Start

July 5, 2022

Primary Completion

September 7, 2023

Study Completion

October 7, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Locations

KR(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Control

Binaural beat

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations