<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/NCT04443517</url>
  </required_header>
  <id_info>
    <org_study_id>AAAS4614</org_study_id>
    <nct_id>NCT04443517</nct_id>
  </id_info>
  <brief_title>Modulation Of Frontal EEG Alpha Oscillations During Maintenance and Emergence Phases of General Anesthesia</brief_title>
  <official_title>Modulation Of Frontal EEG Alpha Oscillations During Maintenance and Emergence Phases of General Anesthesia to Improve Early Neurocognitive Recovery in Older Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators intend to recruit 600 participants to see if alpha power during anesthesia&#xD;
      is influenced by analgesic medication and associated with a reduction of delirium following&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative delirium may manifest in the immediate post-anesthesia care period. Such&#xD;
      episodes appear to be predictive of further episodes of inpatient delirium and associated&#xD;
      adverse outcomes. Intraoperative monitoring of frontal electroencephalogram (EEG) has been&#xD;
      associated with postoperative delirium and poor outcomes. However, the efficacy of titrating&#xD;
      anesthesia medication to proprietary index targets for preventing delirium remains&#xD;
      contentious. The investigators aim to assess the efficacy of two pharmacologic strategies&#xD;
      which could prevent post-anesthesia care unit (PACU) delirium (1) maximization of&#xD;
      intraoperative alpha power during maintenance and (2) switching anesthesia regimes during the&#xD;
      emergence phases of anesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2022</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of PACU Delirium</measure>
    <time_frame>Up to 24 hours post-surgery</time_frame>
    <description>3-Minute Diagnostic Interview for Confusion Assessment Method(3D-CAM), Confusion Assessment Method for the ICU (CAM-ICU), Speech / Language Assessment will be administered to check for signs of delirium.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Frontal Alpha Power</measure>
    <time_frame>Up to 24 hours post-surgery</time_frame>
    <description>The EEG data collected during the study duration will be processed using a customized script. Frontal alpha power (i.e., the cumulative power in the EEG alpha range) will be extracted from the EEGs and analyzed to compare the groups for the differences in the frontal alpha power.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain in PACU: numerical rating score (NRS)</measure>
    <time_frame>Up to 24 hours post-surgery</time_frame>
    <description>The numerical rating score (NRS) requires the patient to rate their pain from 0-10 where 0 is no pain and 10 is the worst pain imaginable (high score indicates worse outcome).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Postoperative Delirium</condition>
  <arm_group>
    <arm_group_label>Maintenance-Alpha Optimization / Wake from Propofol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the first randomization, participants randomized to intraoperative oscillatory EEG alpha optimization will receive individualized titration of anesthetic gas and opioid. During the second randomization, participants randomized to conversion to a propofol infusion for emergence from anesthesia will received an infusion of propofol 400mg/h and simultaneous reduction of desflurane concentration during the final 10-20 minutes of surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maintenance-Alpha Optimization / Wake from Volatile</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During the first randomization, participants randomized to intraoperative oscillatory EEG alpha optimization will receive real-time monitoring of alpha recordings and individualized titration of desflurane and opioid. During the second randomization, participants randomized to standard emergence from volatile anesthesia will be woken up per standard practice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maintenance-Routine Care / Wake from Propofol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During the first randomization, participants randomized to standard of care will receive anesthesia per usual care with quantitative processed EEG index values and EEG wave forms. During the second randomization, participants randomized to conversion to a propofol infusion for emergence from anesthesia will received an infusion of propofol 400mg/h and simultaneous reduction of desflurane concentration during the final 10-20 minutes of surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maintenance-Routine Care / Wake from Volatile</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>During the first randomization, participants randomized to standard of care will receive anesthesia per usual care with quantitative processed EEG index values and EEG wave forms. During the second randomization, participants randomized to standard emergence from volatile anesthesia will be woken up per standard practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Alpha Optimization</intervention_name>
    <description>Intraoperative oscillatory EEG alpha optimization involves real-time acquisition of oscillatory alpha power from the frontal EEG with individualized titration of desflurane and opioid.</description>
    <arm_group_label>Maintenance-Alpha Optimization / Wake from Propofol</arm_group_label>
    <arm_group_label>Maintenance-Alpha Optimization / Wake from Volatile</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Emergence from anesthesia with propofol</intervention_name>
    <description>Infusion of 400 mg/h of propofol during the final 10-20 minutes of surgery. Total doses of propofol administered are likely to be in the range of 1-3 mg/kg.</description>
    <arm_group_label>Maintenance-Alpha Optimization / Wake from Propofol</arm_group_label>
    <arm_group_label>Maintenance-Routine Care / Wake from Propofol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 60 years or over&#xD;
&#xD;
          -  Has capacity to provide informed consent&#xD;
&#xD;
          -  Undergoing elective non-cardiac surgery, which does not involve the head or neck, with&#xD;
             planned volatile-based general anesthesia of expected duration of at least 2 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic pain with opioid requirement or concurrent use of enzyme inducers, e.g.&#xD;
             carbamazepine, phenytoin,&#xD;
&#xD;
          -  Illicit substance use or excessive alcohol intake&#xD;
&#xD;
          -  Refusal by patient or case anesthesiologist responsible for patient's care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul S. Garcia, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paul S. Garcia, MD, PhD</last_name>
    <phone>212-304-7678</phone>
    <email>pg2618@cumc.columbia.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tuan Z. Cassim, BA</last_name>
    <phone>917-539-9926</phone>
    <email>tc3032@cumc.columbia.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Columbia University Irving Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Paul S. Garcia, MD, PhD</last_name>
      <phone>212-304-7678</phone>
      <email>pg2618@cumc.columbia.edu</email>
    </contact>
    <contact_backup>
      <last_name>Tuan Z. Cassim, BA</last_name>
      <phone>917-539-9926</phone>
      <email>tc3032@cumc.columbia.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>February 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>August 4, 2021</last_update_submitted>
  <last_update_submitted_qc>August 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Paul Garcia</investigator_full_name>
    <investigator_title>Associate Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>EEG</keyword>
  <keyword>General Anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergence Delirium</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04443517
org study id: AAAS4614
nct id: NCT04443517
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The investigators intend to recruit 600 participants to see if alpha power during anesthesia
      is influenced by analgesic medication and associated with a reduction of delirium following
      surgery.
Postoperative delirium may manifest in the immediate post-anesthesia care period. Such
      episodes appear to be predictive of further episodes of inpatient delirium and associated
      adverse outcomes. Intraoperative monitoring of frontal electroencephalogram (EEG) has been
      associated with postoperative delirium and poor outcomes. However, the efficacy of titrating
      anesthesia medication to proprietary index targets for preventing delirium remains
      contentious. The investigators aim to assess the efficacy of two pharmacologic strategies
      which could prevent post-anesthesia care unit (PACU) delirium (1) maximization of
      intraoperative alpha power during maintenance and (2) switching anesthesia regimes during the
      emergence phases of anesthesia.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Incidence of PACU Delirium
time frame: Up to 24 hours post-surgery
description: 3-Minute Diagnostic Interview for Confusion Assessment Method(3D-CAM), Confusion Assessment Method for the ICU (CAM-ICU), Speech / Language Assessment will be administered to check for signs of delirium.
measure: Change in Frontal Alpha Power
time frame: Up to 24 hours post-surgery
description: The EEG data collected during the study duration will be processed using a customized script. Frontal alpha power (i.e., the cumulative power in the EEG alpha range) will be extracted from the EEGs and analyzed to compare the groups for the differences in the frontal alpha power.
measure: Change in pain in PACU: numerical rating score (NRS)
time frame: Up to 24 hours post-surgery
description: The numerical rating score (NRS) requires the patient to rate their pain from 0-10 where 0 is no pain and 10 is the worst pain imaginable (high score indicates worse outcome).
arm group label: Maintenance-Alpha Optimization / Wake from Propofol
arm group type: Experimental
description: During the first randomization, participants randomized to intraoperative oscillatory EEG alpha optimization will receive individualized titration of anesthetic gas and opioid. During the second randomization, participants randomized to conversion to a propofol infusion for emergence from anesthesia will received an infusion of propofol 400mg/h and simultaneous reduction of desflurane concentration during the final 10-20 minutes of surgery.
arm group label: Maintenance-Alpha Optimization / Wake from Volatile
arm group type: Active Comparator
description: During the first randomization, participants randomized to intraoperative oscillatory EEG alpha optimization will receive real-time monitoring of alpha recordings and individualized titration of desflurane and opioid. During the second randomization, participants randomized to standard emergence from volatile anesthesia will be woken up per standard practice.
arm group label: Maintenance-Routine Care / Wake from Propofol
arm group type: Active Comparator
description: During the first randomization, participants randomized to standard of care will receive anesthesia per usual care with quantitative processed EEG index values and EEG wave forms. During the second randomization, participants randomized to conversion to a propofol infusion for emergence from anesthesia will received an infusion of propofol 400mg/h and simultaneous reduction of desflurane concentration during the final 10-20 minutes of surgery.
arm group label: Maintenance-Routine Care / Wake from Volatile
arm group type: No Intervention
description: During the first randomization, participants randomized to standard of care will receive anesthesia per usual care with quantitative processed EEG index values and EEG wave forms. During the second randomization, participants randomized to standard emergence from volatile anesthesia will be woken up per standard practice.
intervention type: Procedure
intervention name: Alpha Optimization
description: Intraoperative oscillatory EEG alpha optimization involves real-time acquisition of oscillatory alpha power from the frontal EEG with individualized titration of desflurane and opioid.
arm group label: Maintenance-Alpha Optimization / Wake from Propofol
arm group label: Maintenance-Alpha Optimization / Wake from Volatile
intervention type: Behavioral
intervention name: Emergence from anesthesia with propofol
description: Infusion of 400 mg/h of propofol during the final 10-20 minutes of surgery. Total doses of propofol administered are likely to be in the range of 1-3 mg/kg.
arm group label: Maintenance-Alpha Optimization / Wake from Propofol
arm group label: Maintenance-Routine Care / Wake from Propofol
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Paul S. Garcia, MD, PhD
role: Principal Investigator
affiliation: Columbia University
last name: Paul S. Garcia, MD, PhD
phone: 212-304-7678
email: pg2618@cumc.columbia.edu
last name: Tuan Z. Cassim, BA
phone: 917-539-9926
email: tc3032@cumc.columbia.edu
facility: 
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Paul Garcia
investigator title: Associate Professor of Anesthesiology
mesh term: Emergence Delirium
mesh term: Propofol
sharing ipd: No