<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/NCT03230929</url>
  </required_header>
  <id_info>
    <org_study_id>L-2017-165</org_study_id>
    <nct_id>NCT03230929</nct_id>
  </id_info>
  <brief_title>The Effect of Electromyogram (EMG) Activity on Anesthetic Depth Monitoring</brief_title>
  <official_title>The Effect of EMG Activity on Anesthetic Depth Monitoring : Comparison Between Phase Lag Entropy and BIS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pusan National University Yangsan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pusan National University Yangsan 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>
      Currently, a lot of equipments based on Bispectral index (BIS) is used clinically in order to&#xD;
      measure the depth of anesthesia. Although BIS is used for the measurement of the presence of&#xD;
      consciousness or degree of sedation during general anesthesia, it could be influenced by&#xD;
      factors that affect or interfere with the activity of EEG because it is a numerical value&#xD;
      which is measured by analyzing EEG. The BIS electrode for EEG analysis should be attached to&#xD;
      the patient's forehead and the EEG signal is 0.5 - 30 Hz, the EMG signal is 30 - 300 Hz, and&#xD;
      the BIS analyzes the 0 - 47 Hz signal. Therefore, 30 -47 Hz EMG signal may influence the BIS&#xD;
      value and the BIS value may differ from the actual. In patients with complete muscle&#xD;
      relaxation, the change in BIS varies in proportion to the concentration of anesthetic, but in&#xD;
      a state with less muscle relaxation or arousal period of anesthesia when recovery of muscle&#xD;
      relaxation occurs, BIS value may not accurately reflects the change in the depth of&#xD;
      anesthesia. Although there is a study on the influence of the degree of muscle relaxation on&#xD;
      BIS value, there is no study on whether phase lag entropy (PLE) measuring anesthesia depth&#xD;
      based on different mechanism from BIS is affected by status of muscle relaxation. After&#xD;
      measuring BIS and PLE at the same time, I will compare both of them and investigate the&#xD;
      reliability of the measurement of the depth of anesthesia of PLE and how electromyogram&#xD;
      activity affects PLE.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intravenous administration of 2% propofol and remifentanil would be done for total&#xD;
      intravenous anesthesia. After intravenous injection of rocuronium 0.6 mg/ kg for muscle&#xD;
      relaxation, endotracheal intubation would be performed. Then, anesthesiologist attaches the&#xD;
      sensors of BIS and PLEM 100 on the forehead of the patient, and adheres the neuromuscular&#xD;
      monitoring device on the medial side of the wrist and the ipsilateral thumb to continuously&#xD;
      monitor the state of consciousness and muscle relaxation before, during and after surgery.&#xD;
      Before the end of surgery, the degree of neuromuscular relaxation should be within deep block&#xD;
      (TOF count &lt;2) and the concentration of 2% propofol should be adjusted for maintaining BIS&#xD;
      between 50 and 60. Reversal of muscle relaxant could be performed by intravenous injection of&#xD;
      sugammadex 4 mg/ kg in the case of deep neuromuscular relaxation, and 2 mg / kg in the case&#xD;
      of shallow muscle relaxation degree under neuromuscular monitoring. After then, monitor and&#xD;
      record the values of BIS, phase lag entropy monitor (PLEM) 100, and neuromuscular monitoring&#xD;
      in 1 minute increments for 5 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The difference of phase lag entropy between before and after neuromuscular recovery</measure>
    <time_frame>24 hours</time_frame>
    <description>PLEM 100 is 4-channel electroencephalogram (EEG) monitor and it records electric activity signals of the brain generated from the human body. The anesthesiologist administers sugammadex intravenously at the end of the surgery, and then monitors and records the values of BIS, PLEM 100, and neuromuscular monitoring in 1 minute increments for 5 minutes until neuromuscular recovery is completed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The difference between BIS and phase lag entropy during general anesthesia</measure>
    <time_frame>24 hours</time_frame>
    <description>BIS uses the frequency, amplitude, phase angle of electroencephalogram, and measures the coherence. Finally, it is closely related to the level of sedation and consciousness by the anesthetic agent. PLEM 100 is 4-channel electroencephalogram monitor and it records electric activity signals of the brain generated from the human body. The anesthesiologist continuously monitor the state of consciousness and muscle relaxation from entrance of the patient to the complete recovery of muscle relaxation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>General Anesthetic Drug Overdose</condition>
  <arm_group>
    <arm_group_label>BIS-PLE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anesthesiologist attaches the sensors of BIS and PLEM 100 on the forehead of the patient, and monitor the monitor and record the values of BIS, PLEM 100, and neuromuscular monitoring.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BIS-PLE</intervention_name>
    <description>Anesthesiologist attaches the sensors of BIS and PLEM 100 on the forehead of the patient, and adheres the neuromuscular monitoring device on the medial side of the wrist and the ipsilateral thumb to continuously monitor the state of consciousness and muscle relaxation before, during and after surgery. Reversal of muscle relaxant could be performed by intravenous injection of sugammadex 4 mg/ kg in the case of deep neuromuscular relaxation, and 2 mg / kg in the case of shallow muscle relaxation degree under neuromuscular monitoring. After then, they monitor and record the values of BIS, PLEM 100, and neuromuscular monitoring in 1 minute increments for 5 minutes.</description>
    <arm_group_label>BIS-PLE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient who is scheduled for operation requiring general anesthesia and whose&#xD;
             American Society of Anesthesiologists (ASA) status is I or II.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Who has neuromuscular disease&#xD;
&#xD;
          -  Who takes medicines related neurologic system&#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>Tae-Kyun Kim, PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pusan National University Yangsan Hospital, Geumo-ro 20, Mulgeum-eup, Yangsan, 50612</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pusan National University Yangsan Hospital</name>
      <address>
        <city>Yangsan</city>
        <zip>50612</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 16, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>April 4, 2018</last_update_submitted>
  <last_update_submitted_qc>April 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pusan National University Yangsan Hospital</investigator_affiliation>
    <investigator_full_name>Tae-Kyun Kim</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>EMG, BIS, phase lag entropy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Drug Overdose</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT03230929/Prot_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT03230929/SAP_004.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT03230929/ICF_005.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03230929
org study id: L-2017-165
nct id: NCT03230929
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Currently, a lot of equipments based on Bispectral index (BIS) is used clinically in order to
      measure the depth of anesthesia. Although BIS is used for the measurement of the presence of
      consciousness or degree of sedation during general anesthesia, it could be influenced by
      factors that affect or interfere with the activity of EEG because it is a numerical value
      which is measured by analyzing EEG. The BIS electrode for EEG analysis should be attached to
      the patient's forehead and the EEG signal is 0.5 - 30 Hz, the EMG signal is 30 - 300 Hz, and
      the BIS analyzes the 0 - 47 Hz signal. Therefore, 30 -47 Hz EMG signal may influence the BIS
      value and the BIS value may differ from the actual. In patients with complete muscle
      relaxation, the change in BIS varies in proportion to the concentration of anesthetic, but in
      a state with less muscle relaxation or arousal period of anesthesia when recovery of muscle
      relaxation occurs, BIS value may not accurately reflects the change in the depth of
      anesthesia. Although there is a study on the influence of the degree of muscle relaxation on
      BIS value, there is no study on whether phase lag entropy (PLE) measuring anesthesia depth
      based on different mechanism from BIS is affected by status of muscle relaxation. After
      measuring BIS and PLE at the same time, I will compare both of them and investigate the
      reliability of the measurement of the depth of anesthesia of PLE and how electromyogram
      activity affects PLE.
Intravenous administration of 2% propofol and remifentanil would be done for total
      intravenous anesthesia. After intravenous injection of rocuronium 0.6 mg/ kg for muscle
      relaxation, endotracheal intubation would be performed. Then, anesthesiologist attaches the
      sensors of BIS and PLEM 100 on the forehead of the patient, and adheres the neuromuscular
      monitoring device on the medial side of the wrist and the ipsilateral thumb to continuously
      monitor the state of consciousness and muscle relaxation before, during and after surgery.
      Before the end of surgery, the degree of neuromuscular relaxation should be within deep block
      (TOF count <2) and the concentration of 2% propofol should be adjusted for maintaining BIS
      between 50 and 60. Reversal of muscle relaxant could be performed by intravenous injection of
      sugammadex 4 mg/ kg in the case of deep neuromuscular relaxation, and 2 mg / kg in the case
      of shallow muscle relaxation degree under neuromuscular monitoring. After then, monitor and
      record the values of BIS, phase lag entropy monitor (PLEM) 100, and neuromuscular monitoring
      in 1 minute increments for 5 minutes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: The difference of phase lag entropy between before and after neuromuscular recovery
time frame: 24 hours
description: PLEM 100 is 4-channel electroencephalogram (EEG) monitor and it records electric activity signals of the brain generated from the human body. The anesthesiologist administers sugammadex intravenously at the end of the surgery, and then monitors and records the values of BIS, PLEM 100, and neuromuscular monitoring in 1 minute increments for 5 minutes until neuromuscular recovery is completed.
measure: The difference between BIS and phase lag entropy during general anesthesia
time frame: 24 hours
description: BIS uses the frequency, amplitude, phase angle of electroencephalogram, and measures the coherence. Finally, it is closely related to the level of sedation and consciousness by the anesthetic agent. PLEM 100 is 4-channel electroencephalogram monitor and it records electric activity signals of the brain generated from the human body. The anesthesiologist continuously monitor the state of consciousness and muscle relaxation from entrance of the patient to the complete recovery of muscle relaxation.
arm group label: BIS-PLE
arm group type: Experimental
description: Anesthesiologist attaches the sensors of BIS and PLEM 100 on the forehead of the patient, and monitor the monitor and record the values of BIS, PLEM 100, and neuromuscular monitoring.
intervention type: Device
intervention name: BIS-PLE
description: Anesthesiologist attaches the sensors of BIS and PLEM 100 on the forehead of the patient, and adheres the neuromuscular monitoring device on the medial side of the wrist and the ipsilateral thumb to continuously monitor the state of consciousness and muscle relaxation before, during and after surgery. Reversal of muscle relaxant could be performed by intravenous injection of sugammadex 4 mg/ kg in the case of deep neuromuscular relaxation, and 2 mg / kg in the case of shallow muscle relaxation degree under neuromuscular monitoring. After then, they monitor and record the values of BIS, PLEM 100, and neuromuscular monitoring in 1 minute increments for 5 minutes.
arm group label: BIS-PLE
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Tae-Kyun Kim, PhD.
role: Principal Investigator
affiliation: Pusan National University Yangsan Hospital, Geumo-ro 20, Mulgeum-eup, Yangsan, 50612
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Pusan National University Yangsan Hospital
investigator full name: Tae-Kyun Kim
investigator title: Associate Professor
mesh term: Drug Overdose
sharing ipd: No
provided document: 
provided document: 
provided document: 