<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/NCT03299621</url>
  </required_header>
  <id_info>
    <org_study_id>MD17014</org_study_id>
    <nct_id>NCT03299621</nct_id>
  </id_info>
  <brief_title>Monitoring of Anesthetic Depth and EEG Band Power Using PLE (Phase Lag Entropy) During Propofol Anesthesia</brief_title>
  <acronym>PLE</acronym>
  <official_title>Anesthetic Depth Using PLE (Phase Lag Entropy)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Korea University Anam Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Korea University Anam Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The evaluation of the anesthetic depth monitoring using PLE (Phase Lag Entropy) during&#xD;
      propofol anesthesia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The devices using EEG are commonly used for measuring the depth of consciousness during&#xD;
      anesthesia. However, the existing devices are largely dependent on the biphasic analysis of&#xD;
      1-channel EEG signals, and thus do not provide proper information for anesthetic depth.&#xD;
&#xD;
      Recent study reported that the complexity or diversity of communication between the brain&#xD;
      regions is related to the level of consciousness. In particular, during anesthesia, the phase&#xD;
      synchronization (phase shift) between EEG signals at the front of the brain increases,&#xD;
      indicating a reduction in communication diversity and a close relationship with loss of&#xD;
      consciousness. Therefore, to predict the depth of sleep, a technique for precisely&#xD;
      quantifying the complexity of inter-domain communication in the frontal brain is needed.&#xD;
      Recently, PLEM™ (Inbody co., ltd, Republic of Korea), developed using the phase lag entropy&#xD;
      (PLE), is a 4-channel EEG monitoring device that measures the entropy of the phase difference&#xD;
      pattern between two channels of prefrontal and frontal brain. In addition, PLEM™ is able to&#xD;
      observe changes in band power of EEG (Gamma, Beta, Alpha, Theta, and Delta waves). As the&#xD;
      depth of anesthesia increases, the amplitude and frequency of EEG decreases. Generally, Beta&#xD;
      waves (13-30 Hz) are seen in awake conscious patients and Alpha waves (8-12 Hz) are seen in&#xD;
      patients resting with eyes closed. And Theta waves (4-7 Hz) and Delta waves (0-3 Hz) can be&#xD;
      present in a patient who is sleeping or anesthetized.&#xD;
&#xD;
      The purpose of this study was to evaluate the efficacy for anesthetic depth monitoring of&#xD;
      PLEM™ monitor during propofol anesthesia. The primary outcome of this study was to&#xD;
      investigate the changes of PLE value and band power of EEG (Gamma, Beta, Alpha, Theta, Delta&#xD;
      waves) on the PLEM™ monitor while varying the depth of anesthesia using propofol target&#xD;
      controlled infusion (TCI) during anesthetic induction. The secondary outcomes of this study&#xD;
      were to investigate whether the muscle relaxant affects the PLE value, and to compare the PLE&#xD;
      values with BIS (bispectral index) (Aspect medical system, USA) that was the most widely used&#xD;
      to measure the depth of anesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 13, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PLE (Phase Lag Entropy) value before and after intubation</measure>
    <time_frame>at the time points that propofol target effect site concentration reach to 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation</time_frame>
    <description>Investigators measure the PLE value at the time points that propofol target effect site concentration reach at 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PLE value before and after the injection of muscle relaxant</measure>
    <time_frame>at 3 min after the injection of muscle relaxant, immediately after intubation</time_frame>
    <description>Investigators measure the PLE value before the injection of muscle relaxant, at 3 min after the injection of muscle relaxant, and immediately after intubation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PLE value and BIS value at that time of induction and awakening</measure>
    <time_frame>at the time point of no-response to verbal command during induction (modified Observer's assessment of Alertness/Sedation scale (modified OAA/S scale) = 2, at the time point of response to verbal command during awakening (modified OAA/S scale = 3).</time_frame>
    <description>Investigators measure the PLE value and BIS value at the time point of no-response to verbal command during induction ('modified Observer's assessment of Alertness/Sedation scale (modified OAA/S scale) = 2], at the time point of response to verbal command during awakening [modified OAA/S scale = 3].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bispectral index (BIS) value before and after intubation</measure>
    <time_frame>at the time points that propofol target effect site concentration reach to 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation</time_frame>
    <description>Investigators measure the Bispectral index (BIS) value at time points that propofol target effect site concentration reach to 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Band power (Gamma, Beta, Alpha, Theta, and Delta waves) before and after intubation</measure>
    <time_frame>at the time points that propofol target effect site concentration reach at 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation</time_frame>
    <description>Investigators calculate band power from the data file at the time points that propofol target effect site concentration reach 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Anesthesia, General</condition>
  <arm_group>
    <arm_group_label>PLE (Phase Lag Entropy) monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Investigators monitor the change of PLE value using the sensor of PLEM™ during propofol anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Muscle relaxant injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Investigators monitor the change for PLE value using the sensor of PLEM™ before and after the injection of muscle relaxant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PLE (Phase Lag Entropy)</intervention_name>
    <description>Monitoring of PLE value using the monitoring of PLEM™ device during propofol anesthesia.</description>
    <arm_group_label>PLE (Phase Lag Entropy) monitoring</arm_group_label>
    <other_name>PLEM™ (Inbody co., ltd)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Muscle Relaxant</intervention_name>
    <description>Monitoring of PLE value using the monitoring of PLEM™ device before and after the injection of muscle relaxant that used for tracheal intubation.</description>
    <arm_group_label>Muscle relaxant injection</arm_group_label>
    <other_name>Muscle relaxant (rocuronium)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patients undergoing elective general anesthesia with American Society fo&#xD;
             Anesthesiologist (ASA) physical status I or II (20-60 years)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with difficulty airway&#xD;
&#xD;
          -  Patients with cardiovascular disease&#xD;
&#xD;
          -  Patients with cerebrovascular disease&#xD;
&#xD;
          -  Patients with respiratory disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hye-Won Shin, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea University Anam Hospital, Seoul, Inchon-ro 8-gil 73, Seoul, Republic of Korea</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hyun-Jung Kim, M.D.</last_name>
    <phone>821033859168</phone>
    <email>k87876655@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hye-Won Shin, Ph.D.</last_name>
    <phone>821092735025</phone>
    <email>drhwshin@naver.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Inchon-ro 8-gil 73</state>
        <zip>02841</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hye-Won Shin, Ph.D.</last_name>
      <phone>821092735025</phone>
      <email>drhwshin@naver.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hye Won Shin, M.D., PhD.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>November 13, 2017</last_update_submitted>
  <last_update_submitted_qc>November 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Korea University Anam Hospital</investigator_affiliation>
    <investigator_full_name>Hye-Won Shin</investigator_full_name>
    <investigator_title>Department of Anesthesiology and Pain Medicine</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rocuronium</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03299621
org study id: MD17014
nct id: NCT03299621
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The evaluation of the anesthetic depth monitoring using PLE (Phase Lag Entropy) during
      propofol anesthesia
The devices using EEG are commonly used for measuring the depth of consciousness during
      anesthesia. However, the existing devices are largely dependent on the biphasic analysis of
      1-channel EEG signals, and thus do not provide proper information for anesthetic depth.

      Recent study reported that the complexity or diversity of communication between the brain
      regions is related to the level of consciousness. In particular, during anesthesia, the phase
      synchronization (phase shift) between EEG signals at the front of the brain increases,
      indicating a reduction in communication diversity and a close relationship with loss of
      consciousness. Therefore, to predict the depth of sleep, a technique for precisely
      quantifying the complexity of inter-domain communication in the frontal brain is needed.
      Recently, PLEM™ (Inbody co., ltd, Republic of Korea), developed using the phase lag entropy
      (PLE), is a 4-channel EEG monitoring device that measures the entropy of the phase difference
      pattern between two channels of prefrontal and frontal brain. In addition, PLEM™ is able to
      observe changes in band power of EEG (Gamma, Beta, Alpha, Theta, and Delta waves). As the
      depth of anesthesia increases, the amplitude and frequency of EEG decreases. Generally, Beta
      waves (13-30 Hz) are seen in awake conscious patients and Alpha waves (8-12 Hz) are seen in
      patients resting with eyes closed. And Theta waves (4-7 Hz) and Delta waves (0-3 Hz) can be
      present in a patient who is sleeping or anesthetized.

      The purpose of this study was to evaluate the efficacy for anesthetic depth monitoring of
      PLEM™ monitor during propofol anesthesia. The primary outcome of this study was to
      investigate the changes of PLE value and band power of EEG (Gamma, Beta, Alpha, Theta, Delta
      waves) on the PLEM™ monitor while varying the depth of anesthesia using propofol target
      controlled infusion (TCI) during anesthetic induction. The secondary outcomes of this study
      were to investigate whether the muscle relaxant affects the PLE value, and to compare the PLE
      values with BIS (bispectral index) (Aspect medical system, USA) that was the most widely used
      to measure the depth of anesthesia.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: PLE (Phase Lag Entropy) value before and after intubation
time frame: at the time points that propofol target effect site concentration reach to 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation
description: Investigators measure the PLE value at the time points that propofol target effect site concentration reach at 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation.
measure: PLE value before and after the injection of muscle relaxant
time frame: at 3 min after the injection of muscle relaxant, immediately after intubation
description: Investigators measure the PLE value before the injection of muscle relaxant, at 3 min after the injection of muscle relaxant, and immediately after intubation.
measure: PLE value and BIS value at that time of induction and awakening
time frame: at the time point of no-response to verbal command during induction (modified Observer's assessment of Alertness/Sedation scale (modified OAA/S scale) = 2, at the time point of response to verbal command during awakening (modified OAA/S scale = 3).
description: Investigators measure the PLE value and BIS value at the time point of no-response to verbal command during induction ('modified Observer's assessment of Alertness/Sedation scale (modified OAA/S scale) = 2], at the time point of response to verbal command during awakening [modified OAA/S scale = 3].
measure: Bispectral index (BIS) value before and after intubation
time frame: at the time points that propofol target effect site concentration reach to 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation
description: Investigators measure the Bispectral index (BIS) value at time points that propofol target effect site concentration reach to 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation.
measure: Band power (Gamma, Beta, Alpha, Theta, and Delta waves) before and after intubation
time frame: at the time points that propofol target effect site concentration reach at 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation
description: Investigators calculate band power from the data file at the time points that propofol target effect site concentration reach 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation.
arm group label: PLE (Phase Lag Entropy) monitoring
arm group type: Experimental
description: Investigators monitor the change of PLE value using the sensor of PLEM™ during propofol anesthesia.
arm group label: Muscle relaxant injection
arm group type: Experimental
description: Investigators monitor the change for PLE value using the sensor of PLEM™ before and after the injection of muscle relaxant.
intervention type: Device
intervention name: PLE (Phase Lag Entropy)
description: Monitoring of PLE value using the monitoring of PLEM™ device during propofol anesthesia.
arm group label: PLE (Phase Lag Entropy) monitoring
other name: PLEM™ (Inbody co., ltd)
intervention type: Drug
intervention name: Muscle Relaxant
description: Monitoring of PLE value using the monitoring of PLEM™ device before and after the injection of muscle relaxant that used for tracheal intubation.
arm group label: Muscle relaxant injection
other name: Muscle relaxant (rocuronium)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Hye-Won Shin, Ph.D.
role: Principal Investigator
affiliation: Korea University Anam Hospital, Seoul, Inchon-ro 8-gil 73, Seoul, Republic of Korea
last name: Hyun-Jung Kim, M.D.
phone: 821033859168
email: k87876655@gmail.com
last name: Hye-Won Shin, Ph.D.
phone: 821092735025
email: drhwshin@naver.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Korea University Anam Hospital
investigator full name: Hye-Won Shin
investigator title: Department of Anesthesiology and Pain Medicine
mesh term: Rocuronium