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/NCT06020599</url>
    </required_header>
    <id_info>
      <org_study_id>APHP230375</org_study_id>
      <nct_id>NCT06020599</nct_id>
    </id_info>
    <brief_title>Study of Pharmacological and Clinical Correlates of Frontal Cortical Electroencephalographic (EEG) Signal During the Induction, Maintenance and Emergence Phases of Anesthesia in Children</brief_title>
    <acronym>SPECTRAL-PED</acronym>
    <official_title>Study of Pharmacological and Clinical Correlates of Frontal Cortical Electroencephalographic (EEG) Signal During the Induction, Maintenance and Emergence Phases of Anesthesia in Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assistance Publique - Hôpitaux de Paris</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
    </oversight_info>
    <brief_summary>
      <textblock>
        Using data from a prospective cohort of children receiving general anaesthesia for surgery,&#xD;
        this project will collect pharmacological correlates (doses and timing of administration of&#xD;
        anaesthetic drugs) and clinical correlates (stimulations including nociceptive stimulation,&#xD;
        possible responses such as movement/resumption of spontaneous ventilation during maintenance&#xD;
        of anaesthesia/tachycardia/high blood pressure) of patients during the three phases of&#xD;
        anesthesia (induction, maintenance, emergence).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The usual practice of general anesthesia in children is based on the prescription of&#xD;
        anesthetic drugs with doses adapted to weight and neurological examination focusing on the&#xD;
        functions of the brainstem. Each patient has a specific sensitivity to anesthetic drugs&#xD;
        (inter-individual pharmacokinetic and pharmacodynamic variability).&#xD;
  &#xD;
        This inter-individual variability is likely to cause anesthesia that is too deep or,&#xD;
        conversely, too light, which can be difficult to anticipate and can cause complications,&#xD;
        particularly hemodynamic and neurocognitive. Because of the pharmacokinetics of anesthetic&#xD;
        drugs, once an overdose is present, it will be relatively prolonged (several minutes). This&#xD;
        is the correction of overdose.&#xD;
  &#xD;
        In adults, monitoring of anesthesia adequacy is performed by EEG signal analysis (mainly BIS&#xD;
        (Bispectral Index) monitor, Medtronic, Dublin, Ireland). This practice is not very common in&#xD;
        children.&#xD;
  &#xD;
        Since 2020, an EEG monitor (Sedline, Masimo, Irvine, California, USA) allows the estimation&#xD;
        of the adequacy of anesthesia in children based on an EEG model (spectral density matrix;&#xD;
        double spectrum delta and alpha during the maintenance phase of anesthesia).&#xD;
  &#xD;
        Nevertheless, the pharmacological correlates (doses and delays in reaching the peak of the&#xD;
        effect of drugs) as well as the clinical correlates (loss of verbal contact at induction,&#xD;
        responses to nociceptive stimuli during the maintenance of anesthesia, return of brainstem&#xD;
        functions in the emerging phase) associated with this double delta/alpha spectrum are not&#xD;
        described. In addition, monitor EEG analysis tools cannot correctly describe (in spectral&#xD;
        density matrix) the induction and emergence (awakening) phases of general anesthesia.&#xD;
  &#xD;
        Questions remain about the potentially deleterious effects of general anesthesia in children,&#xD;
        especially in children under one year of age. To the extent that general anesthesia is&#xD;
        necessary for the performance of the surgical procedure, it is essential to have tools&#xD;
        (cortical EEG) that make it possible to adjust the doses of anesthetic drugs to adapt to&#xD;
        inter-individual variability. In children, the use of EEG for estimating the adequacy of&#xD;
        anaesthesia remains incomplete and imperfect.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</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>Pharmacological correlates (doses and timing of administration of anaesthetic drugs) of patients during the three phases of anaesthesia (induction/maintenance/emergence).</measure>
      <time_frame>6 months</time_frame>
      <description>The aim is to assert that a given EEG profile (described by the spectral density matrix, by the unique digital descriptors and by the analogue EEG) is associated with such doses/concentrations of drugs and is associated with probabilities of response (movement/haemodynamics).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical correlates (stimulations including nociceptive stimulation, possible responses such as movement/resumption of spontaneous ventilation during maintenance of anaesthesia/tachycardia/hypertension) of patients during the three phases of anaesthesia.</measure>
      <time_frame>6 months</time_frame>
      <description>The aim is to assert that a given EEG profile (described by the spectral density matrix, by the unique digital descriptors and by the analogue EEG) is associated with such doses/concentrations of drugs and is associated with probabilities of response (movement/haemodynamics).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The calculation of the delta-alpha ratio to help the development of mathematical tools to quantify delta-alpha spectra images on the spectral density matrix during the maintenance phase of anesthesia</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intra-individual correlation of sensitivity between the different phases of anesthesia (induction-maintenance-emergence)</measure>
      <time_frame>6 months</time_frame>
      <description>This is to test the hypothesis that a patient identified as sensitive during the induction phase (time required to move from a delta trace with superimposed alpha to a trace with exclusive delta waves) will also be sensitive (will need lower doses/concentrations of hypnotics) to have a double delta-alpha spectrum during the maintenance phase of anesthesia. If this interindividual sensitivity persists, the patient will need to emerge from anesthesia (persistence of fast waves) at lower concentrations of hypnotics compared to less sensitive patients.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensitivity and specificity of a typical EEG profile (persistent beta/gamma waves) to help predicting extubation against currently used clinical and &quot;scientific&quot; criteria.</measure>
      <time_frame>6 months</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Anesthesia</condition>
    <arm_group>
      <arm_group_label>Children who need general anesthesia for surgery</arm_group_label>
      <description>Children who need general anesthesia for surgery (ENT, dentistry) at Louis Mourier Hospital.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Children requiring general anesthesia for surgery (ENT, dentistry) at Louis Mourier&#xD;
          Hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1 year &lt; age &lt; 18 years&#xD;
  &#xD;
            -  Weight&gt; 10 kg&#xD;
  &#xD;
            -  Child receiving general anesthesia for any scheduled surgical procedure (dentistry and&#xD;
               ENT) at Louis Mourier Hospital&#xD;
  &#xD;
            -  Information for holders of parental authority&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Child with known autism disorder&#xD;
  &#xD;
            -  Refusal of parental authority holders to participate or refusal of the child&#xD;
  &#xD;
            -  Participation in other intervention research&#xD;
  &#xD;
            -  Not affiliated to a social security system&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dan Longrois, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dan Longrois, MD, PhD</last_name>
      <phone>01 47 60 61 35</phone>
      <email>dan.longrois@aphp.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Christian De Tymowski, MD</last_name>
      <phone>01 47 60 61 35</phone>
      <email>christian.detymowski@aphp.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hopital Louis Mourier</name>
        <address>
          <city>Colombes</city>
          <zip>92025</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Dan Longrois, MD, PhD</last_name>
        <phone>01 47 60 61 35</phone>
        <email>dan.longrois@aphp.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>anesthesia</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06020599
  org study id: APHP230375
  nct id: NCT06020599
  lead sponsor: 
  has dmc: No
  Using data from a prospective cohort of children receiving general anaesthesia for surgery,
        this project will collect pharmacological correlates (doses and timing of administration of
        anaesthetic drugs) and clinical correlates (stimulations including nociceptive stimulation,
        possible responses such as movement/resumption of spontaneous ventilation during maintenance
        of anaesthesia/tachycardia/high blood pressure) of patients during the three phases of
        anesthesia (induction, maintenance, emergence).
  The usual practice of general anesthesia in children is based on the prescription of
        anesthetic drugs with doses adapted to weight and neurological examination focusing on the
        functions of the brainstem. Each patient has a specific sensitivity to anesthetic drugs
        (inter-individual pharmacokinetic and pharmacodynamic variability).
  
        This inter-individual variability is likely to cause anesthesia that is too deep or,
        conversely, too light, which can be difficult to anticipate and can cause complications,
        particularly hemodynamic and neurocognitive. Because of the pharmacokinetics of anesthetic
        drugs, once an overdose is present, it will be relatively prolonged (several minutes). This
        is the correction of overdose.
  
        In adults, monitoring of anesthesia adequacy is performed by EEG signal analysis (mainly BIS
        (Bispectral Index) monitor, Medtronic, Dublin, Ireland). This practice is not very common in
        children.
  
        Since 2020, an EEG monitor (Sedline, Masimo, Irvine, California, USA) allows the estimation
        of the adequacy of anesthesia in children based on an EEG model (spectral density matrix;
        double spectrum delta and alpha during the maintenance phase of anesthesia).
  
        Nevertheless, the pharmacological correlates (doses and delays in reaching the peak of the
        effect of drugs) as well as the clinical correlates (loss of verbal contact at induction,
        responses to nociceptive stimuli during the maintenance of anesthesia, return of brainstem
        functions in the emerging phase) associated with this double delta/alpha spectrum are not
        described. In addition, monitor EEG analysis tools cannot correctly describe (in spectral
        density matrix) the induction and emergence (awakening) phases of general anesthesia.
  
        Questions remain about the potentially deleterious effects of general anesthesia in children,
        especially in children under one year of age. To the extent that general anesthesia is
        necessary for the performance of the surgical procedure, it is essential to have tools
        (cortical EEG) that make it possible to adjust the doses of anesthetic drugs to adapt to
        inter-individual variability. In children, the use of EEG for estimating the adequacy of
        anaesthesia remains incomplete and imperfect.
  observational model: Cohort
  time perspective: Prospective
  measure: Pharmacological correlates (doses and timing of administration of anaesthetic drugs) of patients during the three phases of anaesthesia (induction/maintenance/emergence).
  time frame: 6 months
  description: The aim is to assert that a given EEG profile (described by the spectral density matrix, by the unique digital descriptors and by the analogue EEG) is associated with such doses/concentrations of drugs and is associated with probabilities of response (movement/haemodynamics).
  measure: Clinical correlates (stimulations including nociceptive stimulation, possible responses such as movement/resumption of spontaneous ventilation during maintenance of anaesthesia/tachycardia/hypertension) of patients during the three phases of anaesthesia.
  time frame: 6 months
  description: The aim is to assert that a given EEG profile (described by the spectral density matrix, by the unique digital descriptors and by the analogue EEG) is associated with such doses/concentrations of drugs and is associated with probabilities of response (movement/haemodynamics).
  measure: The calculation of the delta-alpha ratio to help the development of mathematical tools to quantify delta-alpha spectra images on the spectral density matrix during the maintenance phase of anesthesia
  time frame: 6 months
  measure: Intra-individual correlation of sensitivity between the different phases of anesthesia (induction-maintenance-emergence)
  time frame: 6 months
  description: This is to test the hypothesis that a patient identified as sensitive during the induction phase (time required to move from a delta trace with superimposed alpha to a trace with exclusive delta waves) will also be sensitive (will need lower doses/concentrations of hypnotics) to have a double delta-alpha spectrum during the maintenance phase of anesthesia. If this interindividual sensitivity persists, the patient will need to emerge from anesthesia (persistence of fast waves) at lower concentrations of hypnotics compared to less sensitive patients.
  measure: Sensitivity and specificity of a typical EEG profile (persistent beta/gamma waves) to help predicting extubation against currently used clinical and "scientific" criteria.
  time frame: 6 months
  arm group label: Children who need general anesthesia for surgery
  description: Children who need general anesthesia for surgery (ENT, dentistry) at Louis Mourier Hospital.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: 18 Years
  healthy volunteers: No
  last name: Dan Longrois, MD, PhD
  role: Principal Investigator
  affiliation: Assistance Publique - Hôpitaux de Paris
  last name: Dan Longrois, MD, PhD
  phone: 01 47 60 61 35
  email: dan.longrois@aphp.fr
  last name: Christian De Tymowski, MD
  phone: 01 47 60 61 35
  email: christian.detymowski@aphp.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  sharing ipd: No