<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/NCT04431557</url>
  </required_header>
  <id_info>
    <org_study_id>201509018RINB</org_study_id>
    <nct_id>NCT04431557</nct_id>
  </id_info>
  <brief_title>The Electroencephalogram Analysis in the Differences Between Inhalation Anesthetic and Propofol.</brief_title>
  <official_title>The Electroencephalogram Analysis in the Differences Between Inhalation Anesthetic and Propofol.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University 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 investigators will record 120 patients who received general anesthesia, their EEG data&#xD;
      recorded from Bispectral Index (BIS) machine for emperical mode decomposition (EMD) analysis,&#xD;
      the investigators decomposed EEG signal to different oscillations and tried to observe the&#xD;
      differences between hypnotic medications through EEG analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The electroencephalography (EEG) is a noninvasive medical technique for monitoring and&#xD;
      recording the electrical activity of brain. The Hilbert-Huang transform (HHT) was proposed to&#xD;
      decompose EEG signal into intrinsic mode functions (IMF) which can obtain instantaneous&#xD;
      frequency data and work well for data that is nonstationary and nonlinear.&#xD;
&#xD;
      The relationship between frontal EEG patterns and hypnotics remain poorly understood. The&#xD;
      investigators only can tell the increase in frontal EEG power and shift power to lower&#xD;
      frequencies during general anesthesia from publications. The investigators are going to&#xD;
      decompose EEG with HHT and find the energy shift during general anesthesia, compare with&#xD;
      different anesthetics.&#xD;
&#xD;
      The investigators will record 120 patients who received general anesthesia, their EEG data&#xD;
      recorded from BIS machine for EMD analysis, the investigators decomposed EEG signal to&#xD;
      different oscillations and tried to observe the differences between hypnotic medications&#xD;
      through EEG analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 19, 2017</start_date>
  <completion_date type="Actual">February 19, 2019</completion_date>
  <primary_completion_date type="Actual">February 19, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The gamma, beta, alpha and theta power of EEG</measure>
    <time_frame>the total duration inclusions in operation room</time_frame>
    <description>We will try to observe the differences between hypnotic medications through EEG decomposed and power analysis.</description>
  </primary_outcome>
  <enrollment type="Actual">268</enrollment>
  <condition>Sevoflurane</condition>
  <condition>Propofol</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study population was focus on the patients who need schedule general anesthesia with&#xD;
        low anesthesia risk (ASA I-II).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-II&#xD;
&#xD;
          -  scheduled surgery who need general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to the BIS patch&#xD;
&#xD;
          -  not suitable for general anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Feng-Fang Tsai, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
  </condition_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/NCT04431557
org study id: 201509018RINB
nct id: NCT04431557
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators will record 120 patients who received general anesthesia, their EEG data
      recorded from Bispectral Index (BIS) machine for emperical mode decomposition (EMD) analysis,
      the investigators decomposed EEG signal to different oscillations and tried to observe the
      differences between hypnotic medications through EEG analysis.
The electroencephalography (EEG) is a noninvasive medical technique for monitoring and
      recording the electrical activity of brain. The Hilbert-Huang transform (HHT) was proposed to
      decompose EEG signal into intrinsic mode functions (IMF) which can obtain instantaneous
      frequency data and work well for data that is nonstationary and nonlinear.

      The relationship between frontal EEG patterns and hypnotics remain poorly understood. The
      investigators only can tell the increase in frontal EEG power and shift power to lower
      frequencies during general anesthesia from publications. The investigators are going to
      decompose EEG with HHT and find the energy shift during general anesthesia, compare with
      different anesthetics.

      The investigators will record 120 patients who received general anesthesia, their EEG data
      recorded from BIS machine for EMD analysis, the investigators decomposed EEG signal to
      different oscillations and tried to observe the differences between hypnotic medications
      through EEG analysis.
observational model: Case-Control
time perspective: Prospective
measure: The gamma, beta, alpha and theta power of EEG
time frame: the total duration inclusions in operation room
description: We will try to observe the differences between hypnotic medications through EEG decomposed and power analysis.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
last name: Feng-Fang Tsai, M.D.
role: Study Director
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Respiratory Aspiration