<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/NCT03797274</url>
  </required_header>
  <id_info>
    <org_study_id>DCMC#7</org_study_id>
    <nct_id>NCT03797274</nct_id>
  </id_info>
  <brief_title>Quantitative EEG During Anesthesia Emergence in Children</brief_title>
  <acronym>qEEG</acronym>
  <official_title>Quantitative Frontal Electroencephalography (EEG) and Postoperative Emergence Delirium Following General Anesthesia in Children: a Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daegu Catholic University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daegu Catholic University Medical Center</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>
      Most drugs used in general anesthesia work on various receptors in the human brain, causing&#xD;
      unconsciousness, loss of memory, and loss of reflection of the autonomic nervous system.&#xD;
      After the anesthesia, baseline physiological function will be attained by administration of&#xD;
      some reversal drugs or as the time goes by. In this process, various side effects may occur.&#xD;
&#xD;
      Emergence delirium (ED) is a representative behavioral disturbance after general anesthesia&#xD;
      in children and that can cause several problems during the recovery period. Previous EEG&#xD;
      studies reported that this phenomenon is related to hyperexcitation of the brain, and&#xD;
      occurrence of epileptiform discharges during anesthesia induction may indicate an increased&#xD;
      vulnerability for the development of a functional brain disorder in these children.&#xD;
&#xD;
      However, to the best of our knowledge, there is no studies concern evaluating quantitative&#xD;
      EEG parameters for prediction of this postoperative negative behavior in children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2019</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">May 29, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of Emergence delirium</measure>
    <time_frame>During 60 minutes after PACU admission</time_frame>
    <description>On arrival at post-anesthesia care unit (PACU), patients are checked post-anesthesia emergence delirium (PAED). The PAED scale is a validated observational measure of 5 aspects of child behavior (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to produce a total score ranging from 0 to 20; greater scores indicate greater severity.&#xD;
If the PAED score is greater than 12, investigators define emergence delirium.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relative power of each brain waves</measure>
    <time_frame>From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway</time_frame>
    <description>Original frontal EEG segments are attained via 2 channel bispectral index monitoring (BIS VISTA™, Aspect Medical Systems, Inc. MA, USA) during the anesthesia period. The EEG is then segmented into 4 s epochs and fast Fourier transform (FFT) analysis is performed for each of these segments. FFT of all these selected EEG segments are computed in the following frequency bands:&#xD;
Delta: 1-4 Hz Theta: 4-8 Hz Alpha: 8-13 Hz Beta: 13-30 Hz&#xD;
And then, the relative power of each frequency bands to the total power of the sum is calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>modified Yale preoperative anxiety score (mYPAS)</measure>
    <time_frame>before anesthesia induction (about 30 min before the surgery)</time_frame>
    <description>mYPAS is the assessment tool for measure the anxiety before induction. Higher score indicates higher anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PAED score during PACU stay</measure>
    <time_frame>During 60 min after PACU admission</time_frame>
    <description>On arrival at post-anesthesia care unit (PACU) and every 10 min from then, patients were checked PAED. The PAED scale is a validated observational measure of 5 aspects of child behavior (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to produce a total score ranging from 0 to 20; greater scores indicate greater severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FLACC score on initial, 10, 20, and 30 min</measure>
    <time_frame>During 60 minutes after PACU admission]</time_frame>
    <description>Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Watcha scale on initial, 10, 20, and 30 min</measure>
    <time_frame>During 60 minutes after PACU admission</time_frame>
    <description>On arrival and 10, 20, and 30 min after PACU admission, patients were checked Watcha scale as following 4-point scale&#xD;
calm&#xD;
crying, but can be consoled&#xD;
Crying, cannot be consoled&#xD;
Agitated and thrashing around&#xD;
Higher score indicates higher agitation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delta-theta to alpha-beta ratio (DTABR)</measure>
    <time_frame>From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway</time_frame>
    <description>From the relative power of each brain waves, the investigators calculated the ratio as follows:&#xD;
DTABR = (Delta wave + Theta wave)/(alpha wave + beta wave)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delta to alpha ratio</measure>
    <time_frame>From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway</time_frame>
    <description>From the relative power of each brain waves, the investigators calculated the ratio as follows:&#xD;
DAR = Delta wave / alpha wave</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Theta to beta ratio (TBR)</measure>
    <time_frame>From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway</time_frame>
    <description>From the relative power of each brain waves, the investigators calculated the ratio as follows:&#xD;
TBR = Theta wave / beta wave</description>
  </secondary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Anesthesia, General</condition>
  <condition>Electroencephalography</condition>
  <condition>Brain Waves</condition>
  <condition>Psychology, Children</condition>
  <condition>Child Behavior</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This study collects subjects from a tertiary university hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged between 2 and 10 years of American Society of Anesthesiologists physical&#xD;
             status (ASA PS) I or II who are planned to receive surgery under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If the guardian and the subject are difficult to evaluate normally due to language&#xD;
             barriers/language disorders/delay or autistic disorder&#xD;
&#xD;
          -  with developmental delay, neurological disorders or psychiatric diseases associated&#xD;
             with symptoms of agitation, anxiety, attention deficit, sleep disturbances, etc&#xD;
&#xD;
          -  refusal of consent&#xD;
&#xD;
          -  Recent history (within a month) of received general anesthesia or surgery&#xD;
&#xD;
          -  presence of congenital or other genetic conditions thought to influence brain&#xD;
             development&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eugene Kim, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Assistant professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eugene Kim</name>
      <address>
        <city>Daegu</city>
        <state>Nam-gu</state>
        <zip>42472</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 5, 2019</study_first_submitted>
  <study_first_submitted_qc>January 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>September 2, 2019</last_update_submitted>
  <last_update_submitted_qc>September 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Daegu Catholic University Medical Center</investigator_affiliation>
    <investigator_full_name>Eugene Kim</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03797274
org study id: DCMC#7
nct id: NCT03797274
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Most drugs used in general anesthesia work on various receptors in the human brain, causing
      unconsciousness, loss of memory, and loss of reflection of the autonomic nervous system.
      After the anesthesia, baseline physiological function will be attained by administration of
      some reversal drugs or as the time goes by. In this process, various side effects may occur.

      Emergence delirium (ED) is a representative behavioral disturbance after general anesthesia
      in children and that can cause several problems during the recovery period. Previous EEG
      studies reported that this phenomenon is related to hyperexcitation of the brain, and
      occurrence of epileptiform discharges during anesthesia induction may indicate an increased
      vulnerability for the development of a functional brain disorder in these children.

      However, to the best of our knowledge, there is no studies concern evaluating quantitative
      EEG parameters for prediction of this postoperative negative behavior in children.
observational model: Cohort
time perspective: Prospective
measure: Occurrence of Emergence delirium
time frame: During 60 minutes after PACU admission
description: On arrival at post-anesthesia care unit (PACU), patients are checked post-anesthesia emergence delirium (PAED). The PAED scale is a validated observational measure of 5 aspects of child behavior (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to produce a total score ranging from 0 to 20; greater scores indicate greater severity.
If the PAED score is greater than 12, investigators define emergence delirium.
measure: Relative power of each brain waves
time frame: From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway
description: Original frontal EEG segments are attained via 2 channel bispectral index monitoring (BIS VISTA™, Aspect Medical Systems, Inc. MA, USA) during the anesthesia period. The EEG is then segmented into 4 s epochs and fast Fourier transform (FFT) analysis is performed for each of these segments. FFT of all these selected EEG segments are computed in the following frequency bands:
Delta: 1-4 Hz Theta: 4-8 Hz Alpha: 8-13 Hz Beta: 13-30 Hz
And then, the relative power of each frequency bands to the total power of the sum is calculated.
measure: modified Yale preoperative anxiety score (mYPAS)
time frame: before anesthesia induction (about 30 min before the surgery)
description: mYPAS is the assessment tool for measure the anxiety before induction. Higher score indicates higher anxiety.
measure: PAED score during PACU stay
time frame: During 60 min after PACU admission
description: On arrival at post-anesthesia care unit (PACU) and every 10 min from then, patients were checked PAED. The PAED scale is a validated observational measure of 5 aspects of child behavior (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to produce a total score ranging from 0 to 20; greater scores indicate greater severity.
measure: FLACC score on initial, 10, 20, and 30 min
time frame: During 60 minutes after PACU admission]
description: Face, legs, activity, cry, and consolability (FLACC) score is checked every 10min after PACU admission
measure: Watcha scale on initial, 10, 20, and 30 min
time frame: During 60 minutes after PACU admission
description: On arrival and 10, 20, and 30 min after PACU admission, patients were checked Watcha scale as following 4-point scale
calm
crying, but can be consoled
Crying, cannot be consoled
Agitated and thrashing around
Higher score indicates higher agitation.
measure: Delta-theta to alpha-beta ratio (DTABR)
time frame: From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway
description: From the relative power of each brain waves, the investigators calculated the ratio as follows:
DTABR = (Delta wave + Theta wave)/(alpha wave + beta wave)
measure: Delta to alpha ratio
time frame: From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway
description: From the relative power of each brain waves, the investigators calculated the ratio as follows:
DAR = Delta wave / alpha wave
measure: Theta to beta ratio (TBR)
time frame: From the cessation of sevoflurane inhalation to the extubation of airway devices such as tracheal tubes or laryngeal mask airway
description: From the relative power of each brain waves, the investigators calculated the ratio as follows:
TBR = Theta wave / beta wave
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 10 Years
healthy volunteers: No
last name: Eugene Kim, MD, PhD
role: Study Chair
affiliation: Assistant professor
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Daegu Catholic University Medical Center
investigator full name: Eugene Kim
investigator title: Assistant professor
sharing ipd: Undecided