Effect of Binaural Beats for Maintenance of General Anesthesia (BB)

August 15, 2023 updated by: Seoul National University Hospital

) 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:

  • 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jeong-Hwa Seo, MD., PhD.
  • Phone Number: +82-10-55020551
  • Email: eongpa@empas.com

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
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
Apply wave file created in silence.
Experimental: Binaural Beat
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
Apply wave file which is intended to generate binaural beats by applying waves of different frequency (1Hz difference) in each ear.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the starting of surgery to the final suture of skin

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
End tidal minimal alveolar concentration - Maximum
Time Frame: From the starting of surgery to the final suture of skin
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
Time Frame: From the starting of surgery to the final suture of skin
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
Time Frame: Right after arriving the operating room
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
Time Frame: Just before leaving the post anesthesia care unit
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
Time Frame: From the starting to the end of general anesthesia
Noninvasive blood pressure (systolic & diastolic & mean, mmHg)
From the starting to the end of general anesthesia
Vital sign
Time Frame: From the starting to the end of general anesthesia
Heart rate (bpm)
From the starting to the end of general anesthesia
Vital sign
Time Frame: From the starting to the end of general anesthesia
Saturation by pulse oximeter (%)
From the starting to the end of general anesthesia
Brain wave
Time Frame: From the starting of surgery to the final suture of skin
Patient state index (PSI) by Sedline device
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
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
Time Frame: During the patients stay in post anesthesia care unit
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
Time Frame: Since the patient leaves the post anesthesia care unit, until post operative 24 hours
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
Time Frame: While the patient stay in post anesthesia care unit
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
Time Frame: 24 hours after operation
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
Time Frame: Since the patient leaves the post anesthesia care unit, until post operative 24 hours
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
Time Frame: Since the patient leaves the post anesthesia care unit, until post operative 48 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jeong-Hwa Seo, MD., PhD., Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

July 29, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2306-028-1437

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anesthesia, General

Clinical Trials on Silent

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe