xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06002568</url>
    </required_header>
    <id_info>
      <org_study_id>2306-028-1437</org_study_id>
      <nct_id>NCT06002568</nct_id>
    </id_info>
    <brief_title>Effect of Binaural Beats for Maintenance of General Anesthesia</brief_title>
    <acronym>BB</acronym>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seoul National University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Seoul National University Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to learn about the effects of binaural beats on&#xD;
        maintenance of general anesthesia in patients undergoing thyroidectomy without intraoperative&#xD;
        neuromonitoring.&#xD;
  &#xD;
        The main question it aims to answer is:&#xD;
  &#xD;
          -  1) Does applying binaural beats during surgery reduce the gas anesthetics (especially&#xD;
             sevoflurane) requirement to maintaining adequate anesthetic depth during general&#xD;
             anesthesia?&#xD;
  &#xD;
          -  2) Does applying binaural beats during surgery affect intraoperative hemodynamic&#xD;
             stability or post operative nausea and vomiting?&#xD;
  &#xD;
        Participants will wear headsets with a sound generator which contains music files (binaural&#xD;
        beat file in the intervention group (BB) ; silent file in control group (C)) according to the&#xD;
        randomization. Researchers will compare the BB and C group to see if intraoperative binaural&#xD;
        beats reduce the requirements of sevoflurane for maintaining adequate anesthetic depth.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will look at thyroidectomy patients without neuromonitoring. Before entering the&#xD;
        operating room, patients will be randomized according to the randomization table, with the&#xD;
        test group receiving a sound generating device with a binaural sound file and the control&#xD;
        group receiving a sound generating device with a silent file. After entering the operating&#xD;
        room, electrocardiogram, pulse oxymetry, non-invasive blood pressure monitor, and sensor for&#xD;
        depth of anesthesia will be attached. At the beginning of anesthesia induction, the headset&#xD;
        will be placed on the patient and a sound generator will be connected to the headset to play&#xD;
        the file. The induction of anesthesia will be done with administration of fentanyl and&#xD;
        propofol in both groups, and after confirming that the patient is unresponsive to voice,&#xD;
        rocuronium and sevoflurane will be administrated to the patient. During the operation, the&#xD;
        inhaled anesthetic concentration will be adjusted to maintain a patient state index (PSI)&#xD;
        between 25 and 50. Fentanyl can be titrated up to 100 mcg to account for the hemodynamic&#xD;
        response to intraoperative pain, and neuromuscular blocking agents are titrated to maintain a&#xD;
        train of four (TOF) count of 1-3. The headset is continuously applied to the patient during&#xD;
        surgery, and blood pressure, pulse oximetry, PSI, end tidal sevoflurane and end tidal minimal&#xD;
        alveolar concentration will be monitored during the operation. At the time of the final&#xD;
        suture of the skin, the sound generator will be removed from the headset. Save the raw EEG&#xD;
        data from the Sedline® sensor for further analytical evaluation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">July 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 29, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>A prospective randomized, placebo-controlled trial</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Average end tidal sevoflurane concentration</measure>
      <time_frame>From the starting of surgery to the final suture of skin</time_frame>
      <description>Average end tidal sevoflurane concentrations required for maintenance of general anesthesia from surgical incision to skin closure</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>End tidal minimal alveolar concentration - Maximum</measure>
      <time_frame>From the starting of surgery to the final suture of skin</time_frame>
      <description>Maximal value of end tidal minimal alveolar concentration during maintenance of general anesthesia</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>End tidal minimal alveolar concentration - Minimum</measure>
      <time_frame>From the starting of surgery to the final suture of skin</time_frame>
      <description>Minimal value of end tidal minimal alveolar concentration during maintenance of general anesthesia</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety</measure>
      <time_frame>Right after arriving the operating room</time_frame>
      <description>Anxiety is evaluated using visual analogue score(0-100mm ruler without a scale), after entering the operating room</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety</measure>
      <time_frame>Just before leaving the post anesthesia care unit</time_frame>
      <description>Anxiety is evaluated using visual analogue score(0-100mm ruler without a scale), just before leaving the post anesthesia care unit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vital sign</measure>
      <time_frame>From the starting to the end of general anesthesia</time_frame>
      <description>Noninvasive blood pressure (systolic &amp; diastolic &amp; mean, mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vital sign</measure>
      <time_frame>From the starting to the end of general anesthesia</time_frame>
      <description>Heart rate (bpm)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vital sign</measure>
      <time_frame>From the starting to the end of general anesthesia</time_frame>
      <description>Saturation by pulse oximeter (%)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brain wave</measure>
      <time_frame>From the starting of surgery to the final suture of skin</time_frame>
      <description>Patient state index (PSI) by Sedline device</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brain wave</measure>
      <time_frame>From the starting of surgery to the final suture of skin</time_frame>
      <description>brainwaves (raw data) which are collected in the Sedline device - alpha, beta, theta, delta, gamma brain wave</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post operative nausea vomiting</measure>
      <time_frame>During the patients stay in post anesthesia care unit</time_frame>
      <description>The incidence of post operative nausea vomiting, in the post anesthesia care unit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post operative nausea vomiting</measure>
      <time_frame>Since the patient leaves the post anesthesia care unit, until post operative 24 hours</time_frame>
      <description>The incidence of post operative nausea vomiting, in the ward within 24 hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post operative pain</measure>
      <time_frame>While the patient stay in post anesthesia care unit</time_frame>
      <description>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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post operative pain</measure>
      <time_frame>24 hours after operation</time_frame>
      <description>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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delirium</measure>
      <time_frame>Since the patient leaves the post anesthesia care unit, until post operative 24 hours</time_frame>
      <description>The incidence of delirium in the ward within 24 hours after operation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delirium</measure>
      <time_frame>Since the patient leaves the post anesthesia care unit, until post operative 48 hours</time_frame>
      <description>The incidence of delirium in the ward within 48 hours after operation</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">122</enrollment>
    <condition>Anesthesia, General</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Binaural Beat</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Silent</intervention_name>
      <description>Apply wave file created in silence.</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Binaural beats</intervention_name>
      <description>Apply wave file which is intended to generate binaural beats by applying waves of different frequency (1Hz difference) in each ear.</description>
      <arm_group_label>Binaural Beat</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who are scheduled for thyroidectomy without neuromonitoring&#xD;
  &#xD;
            -  Patients aged 20-60 who require general anesthesia over 2 hours&#xD;
  &#xD;
            -  Patients who are able to provide written consent to participate in the clinical trial,&#xD;
               to understand the procedure of this clinical trial, and to fill out the questionnaire&#xD;
               appropriately&#xD;
  &#xD;
            -  Patients with ASA physical status classification 1-2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with hearing loss or using hearing aids&#xD;
  &#xD;
            -  Patients who received narcotic analgesics or sedative drugs within 1 week&#xD;
  &#xD;
            -  Patients with alcohol or drug dependence&#xD;
  &#xD;
            -  Patients with drug hypersensitivity to sevoflurane&#xD;
  &#xD;
            -  Patients with family history or past history of malignant hyperthermia&#xD;
  &#xD;
            -  Patients with neuromuscular disease of myasthenia gravis&#xD;
  &#xD;
            -  Patients with arrhythmia, cardiovascular disease, and decreased heart function&#xD;
  &#xD;
            -  Patients with kidney failure&#xD;
  &#xD;
            -  Patients who are judged to be inappropriate for this clinical trial according to the&#xD;
               opinions of investigators&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jeong-Hwa Seo, MD., PhD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Seoul National University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jeong-Hwa Seo, MD., PhD.</last_name>
      <phone>+82-10-55020551</phone>
      <email>eongpa@empas.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Seoul National University Hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>16571982</PMID>
    </reference>
    <reference>
      <citation>Torri G. Inhalation anesthetics: a review. Minerva Anestesiol. 2010 Mar;76(3):215-28.</citation>
      <PMID>20203550</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>36084424</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>27752068</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>36421228</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>19293700</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>22801049</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>34013463</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>16115248</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>27740618</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>36371942</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>32653082</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>23860442</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>35772250</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Sevoflurane</keyword>
    <keyword>Brain waves</keyword>
    <keyword>Binaural Beats</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06002568
  org study id: 2306-028-1437
  nct id: NCT06002568
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A prospective randomized, placebo-controlled trial
  primary purpose: Prevention
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Average end tidal sevoflurane concentration
  time frame: From the starting of surgery to the final suture of skin
  description: Average end tidal sevoflurane concentrations required for maintenance of general anesthesia from surgical incision to skin closure
  measure: End tidal minimal alveolar concentration - Maximum
  time frame: From the starting of surgery to the final suture of skin
  description: Maximal value of end tidal minimal alveolar concentration during maintenance of general anesthesia
  measure: End tidal minimal alveolar concentration - Minimum
  time frame: From the starting of surgery to the final suture of skin
  description: Minimal value of end tidal minimal alveolar concentration during maintenance of general anesthesia
  measure: Anxiety
  time frame: Right after arriving the operating room
  description: Anxiety is evaluated using visual analogue score(0-100mm ruler without a scale), after entering the operating room
  measure: Anxiety
  time frame: Just before leaving the post anesthesia care unit
  description: Anxiety is evaluated using visual analogue score(0-100mm ruler without a scale), just before leaving the post anesthesia care unit
  measure: Vital sign
  time frame: From the starting to the end of general anesthesia
  description: Noninvasive blood pressure (systolic & diastolic & mean, mmHg)
  measure: Vital sign
  time frame: From the starting to the end of general anesthesia
  description: Heart rate (bpm)
  measure: Vital sign
  time frame: From the starting to the end of general anesthesia
  description: Saturation by pulse oximeter (%)
  measure: Brain wave
  time frame: From the starting of surgery to the final suture of skin
  description: Patient state index (PSI) by Sedline device
  measure: Brain wave
  time frame: From the starting of surgery to the final suture of skin
  description: brainwaves (raw data) which are collected in the Sedline device - alpha, beta, theta, delta, gamma brain wave
  measure: Post operative nausea vomiting
  time frame: During the patients stay in post anesthesia care unit
  description: The incidence of post operative nausea vomiting, in the post anesthesia care unit
  measure: Post operative nausea vomiting
  time frame: Since the patient leaves the post anesthesia care unit, until post operative 24 hours
  description: The incidence of post operative nausea vomiting, in the ward within 24 hours
  measure: Post operative pain
  time frame: While the patient stay in post anesthesia care unit
  description: 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
  measure: Post operative pain
  time frame: 24 hours after operation
  description: 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
  measure: Delirium
  time frame: Since the patient leaves the post anesthesia care unit, until post operative 24 hours
  description: The incidence of delirium in the ward within 24 hours after operation
  measure: Delirium
  time frame: Since the patient leaves the post anesthesia care unit, until post operative 48 hours
  description: The incidence of delirium in the ward within 48 hours after operation
  arm group label: Control
  arm group type: Placebo Comparator
  description: 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.
  arm group label: Binaural Beat
  arm group type: Experimental
  description: 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.
  intervention type: Procedure
  intervention name: Silent
  description: Apply wave file created in silence.
  arm group label: Control
  intervention type: Procedure
  intervention name: Binaural beats
  description: Apply wave file which is intended to generate binaural beats by applying waves of different frequency (1Hz difference) in each ear.
  arm group label: Binaural Beat
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jeong-Hwa Seo, MD., PhD.
  role: Principal Investigator
  affiliation: Seoul National University Hospital
  last name: Jeong-Hwa Seo, MD., PhD.
  phone: +82-10-55020551
  email: eongpa@empas.com
  facility: 
  country: Korea, Republic of
  citation: 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
  citation: Torri G. Inhalation anesthetics: a review. Minerva Anestesiol. 2010 Mar;76(3):215-28.
  PMID: 20203550
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