<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/NCT03040024</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00086609</org_study_id>
    <nct_id>NCT03040024</nct_id>
  </id_info>
  <brief_title>Delirium Prevention With Ketamine in Ear, Nose, and Throat (ENT) Patients</brief_title>
  <official_title>A Randomized Placebo-controlled Pilot Study of Single-dose Intraoperative Ketamine for the Prevention of Delirium in Otolaryngeal Cancer Surgery Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</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 goal of this prospective randomized double blinded placebo controlled study is to&#xD;
      investigate if a single dose of ketamine in addition to standard anesthesia will reduce the&#xD;
      risk of delirium in otolaryngeal cancer patients postoperatively. Ketamine's effect on&#xD;
      post-operative pain and opioid use will be measured as well. Electroencephalogram (EEG) will&#xD;
      be utilized during the surgical procedure to evaluate its potential as a possible predictive&#xD;
      device for delirium.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single center prospective randomized double blinded placebo controlled study.&#xD;
&#xD;
      The primary aim of the study is to optimize the intraoperative treatment protocol for head&#xD;
      and neck cancer patients to reduce the incidence of delirium and associated postoperative&#xD;
      cognitive dysfunction. Secondary aims are to determine the dose response relationship for&#xD;
      intraoperative ketamine and delirium reduction, determine if a single dose of ketamine will&#xD;
      reduce post-operative pain and opioid requirements, determine if raw electroencephalogram&#xD;
      (EEG) data can predict postoperative delirium during general anesthesia, and to evaluate&#xD;
      length of intensive care unit (ICU) and length of hospital stay.&#xD;
&#xD;
      Participants will be randomized to one of three groups after administration of general&#xD;
      anesthesia; one dose of .5 mg/kg intravenous (IV) Ketamine, 1.0 mg/kg of IV Ketamine, or IV&#xD;
      placebo.&#xD;
&#xD;
      An EEG will be used during the surgical procedure to gather raw data for off line analysis&#xD;
      among patients developing post-operative delirium.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Halted due to COVID 19; we believe we have adequate data for analysis&#xD;
  </why_stopped>
  <start_date type="Actual">March 17, 2017</start_date>
  <completion_date type="Actual">April 24, 2020</completion_date>
  <primary_completion_date type="Actual">February 24, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score</measure>
    <time_frame>Baseline (Up to 30 minutes after PACU arrival), Post Operative (PACU discharge up to 6 hours)</time_frame>
    <description>The CAM-ICU assesses four features: 1) acute change or fluctuation in mental status from baseline, 2) inattention, 3) altered level of consciousness, and 4) disorganized thinking. The measure reports whether a participant meets criteria for delirium by summing the number of features answered as &quot;present&quot;. Feature 1 plus 2 and either 3 or 4 present = delirium positive. Results are expressed as number of participants with or without delirium at each time frame.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Behavioral Pain Scale (Non-Intubated) Score</measure>
    <time_frame>Post Operation (Up to 6 Hours), Post Operation Day 0</time_frame>
    <description>The Behavioral Pain Scale. Scores range from 3 (no pain) to 12 (maximum pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score</measure>
    <time_frame>Baseline, Post Surgery (PACU), Post surgery (POD 0), Post surgery (POD 1), Post surgery (POD 2), Post surgery (POD 3), Post surgery (follow up visit - Up to 6 weeks)</time_frame>
    <description>Scores range from 0 (no pain) to 10 (worst pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mini Cog Score</measure>
    <time_frame>Baseline, Post Surgery (Up to 6 Weeks)</time_frame>
    <description>The Mini-Cog is a 3-minute instrument that can increase detection of cognitive impairment. A score ranging from 0-2 indicates positive screen for dementia. A score ranging from 3-5 indicates negative screen for dementia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mini-Mental Status Examination (MMSE) Score</measure>
    <time_frame>Baseline, Post Surgery (Up to 6 Weeks)</time_frame>
    <description>The MMSE is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this (0-24), scores can indicate cognitive impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cognitive Failure Questionnaire (CFQ) Score</measure>
    <time_frame>Baseline, Post Surgery (Up to 6 Weeks)</time_frame>
    <description>The CFQ is a 25-item self-report measure of failures in attention, perception, memory, and action. Participants are asked to indicate on a 5-point scale how often they have experienced each failure in the past months, from 0 (never) to 5 (very often). Scores range from 0 to 100 a higher score indicating more failures in attention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post Operative Narcotics Use</measure>
    <time_frame>Post Intervention (Intraoperative), Post Intervention (POD 0), Post Intervention (POD 1),Post Intervention (POD 2),Post Intervention (POD 3), Post Intervention (Follow up visit-up to 6 weeks post intervention)</time_frame>
    <description>The total amount of narcotics used measured in morphine milligram equivalents (MME).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Associations of Intraoperative EEG Patterns With PACU Delirium</measure>
    <time_frame>Intraoperative EEG and delirium during PACU stay</time_frame>
    <description>The investigators compared the relative beta power derived from the normalized power spectral density (PSD) in patients with and without PACU delirium (positive and negative delirium). Only a total of 38 EEGs with sufficient quality were analyzed. Results are expressed in percentage of cumulative power. A higher beta power correlates with worse outcome. Averages and standard deviations are shown.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Otolaryngeal Cancer</condition>
  <arm_group>
    <arm_group_label>Ketamine 0.5 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ketamine 1.0 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.</description>
    <arm_group_label>Ketamine 0.5 mg/kg</arm_group_label>
    <arm_group_label>Ketamine 1.0 mg/kg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Saline Solution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electroencephalogram (EEG)</intervention_name>
    <description>A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
    <arm_group_label>Ketamine 0.5 mg/kg</arm_group_label>
    <arm_group_label>Ketamine 1.0 mg/kg</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current diagnosis of otolaryngeal cancer and undergoing surgery with general&#xD;
             anesthesia&#xD;
&#xD;
          -  Competent to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Monitored Anesthesia Care (i.e., regional anesthesia alone without plans for general&#xD;
             anesthesia)&#xD;
&#xD;
          -  Surgery involving the eye, eyebrow, forehead, or frontal scalp near the sensor&#xD;
             placement&#xD;
&#xD;
          -  Poor health literacy&#xD;
&#xD;
          -  Allergy, or have experienced any drug reaction to ketamine&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Currently in active alcohol withdrawal&#xD;
&#xD;
          -  Taking buprenorphine for chronic pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vanessa Moll, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University Hospital Midtown</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <results_first_submitted>February 24, 2021</results_first_submitted>
  <results_first_submitted_qc>February 24, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 19, 2021</results_first_posted>
  <last_update_submitted>July 7, 2021</last_update_submitted>
  <last_update_submitted_qc>July 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Amit Prabhakar</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Anesthesiology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03040024/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ketamine 0.5 mg/kg</title>
          <description>Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg.&#xD;
Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
        </group>
        <group group_id="P2">
          <title>Ketamine 1.0 mg/kg</title>
          <description>Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg.&#xD;
Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo.&#xD;
Placebo: Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ketamine 0.5 mg/kg</title>
          <description>Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg.&#xD;
Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
        </group>
        <group group_id="B2">
          <title>Ketamine 1.0 mg/kg</title>
          <description>Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg.&#xD;
Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo.&#xD;
Placebo: Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="24"/>
            <count group_id="B4" value="71"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.7" spread="8.6"/>
                    <measurement group_id="B2" value="64.6" spread="12.4"/>
                    <measurement group_id="B3" value="64.5" spread="11.5"/>
                    <measurement group_id="B4" value="64.3" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score</title>
        <description>The CAM-ICU assesses four features: 1) acute change or fluctuation in mental status from baseline, 2) inattention, 3) altered level of consciousness, and 4) disorganized thinking. The measure reports whether a participant meets criteria for delirium by summing the number of features answered as &quot;present&quot;. Feature 1 plus 2 and either 3 or 4 present = delirium positive. Results are expressed as number of participants with or without delirium at each time frame.</description>
        <time_frame>Baseline (Up to 30 minutes after PACU arrival), Post Operative (PACU discharge up to 6 hours)</time_frame>
        <population>Unable to collect data in 15 participants. N=12: Provider not available. N=2 No PACU. N=1 Physician Decision (withdrawal)</population>
        <group_list>
          <group group_id="O1">
            <title>Ketamine 0.5 mg/kg</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg.&#xD;
Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
          <group group_id="O2">
            <title>Ketamine 1.0 mg/kg</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg.&#xD;
Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo.&#xD;
Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score</title>
          <description>The CAM-ICU assesses four features: 1) acute change or fluctuation in mental status from baseline, 2) inattention, 3) altered level of consciousness, and 4) disorganized thinking. The measure reports whether a participant meets criteria for delirium by summing the number of features answered as &quot;present&quot;. Feature 1 plus 2 and either 3 or 4 present = delirium positive. Results are expressed as number of participants with or without delirium at each time frame.</description>
          <population>Unable to collect data in 15 participants. N=12: Provider not available. N=2 No PACU. N=1 Physician Decision (withdrawal)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Delirium CAM-ICU Score at PACU Arrival</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Delirium CAM-ICU Score at PACU Arrival</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Delirium CAM-ICU Score at PACU Discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Delirium CAM-ICU Score at PACU Discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Behavioral Pain Scale (Non-Intubated) Score</title>
        <description>The Behavioral Pain Scale. Scores range from 3 (no pain) to 12 (maximum pain).</description>
        <time_frame>Post Operation (Up to 6 Hours), Post Operation Day 0</time_frame>
        <population>Unable to collect information for this outcome. The investigators collected the pain scales from the EMR. The BPS was not routinely collected in the hospital and they only report Visual analog scale (VAS).</population>
        <group_list>
          <group group_id="O1">
            <title>Ketamine 0.5 mg/kg</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg.&#xD;
Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
          <group group_id="O2">
            <title>Ketamine 1.0 mg/kg</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg.&#xD;
Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo.&#xD;
Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Behavioral Pain Scale (Non-Intubated) Score</title>
          <description>The Behavioral Pain Scale. Scores range from 3 (no pain) to 12 (maximum pain).</description>
          <population>Unable to collect information for this outcome. The investigators collected the pain scales from the EMR. The BPS was not routinely collected in the hospital and they only report Visual analog scale (VAS).</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score</title>
        <description>Scores range from 0 (no pain) to 10 (worst pain).</description>
        <time_frame>Baseline, Post Surgery (PACU), Post surgery (POD 0), Post surgery (POD 1), Post surgery (POD 2), Post surgery (POD 3), Post surgery (follow up visit - Up to 6 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ketamine 0.5 mg/kg</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg.&#xD;
Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
          <group group_id="O2">
            <title>Ketamine 1.0 mg/kg</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg.&#xD;
Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo.&#xD;
Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score</title>
          <description>Scores range from 0 (no pain) to 10 (worst pain).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Pain Level assessed by the Visual Analog Scale (VAS) Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.50" spread="3.25"/>
                    <measurement group_id="O2" value="4.36" spread="2.94"/>
                    <measurement group_id="O3" value="2.30" spread="2.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (PACU)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="2.45"/>
                    <measurement group_id="O2" value="2.56" spread="3.28"/>
                    <measurement group_id="O3" value="1.63" spread="3.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.76" spread="3.86"/>
                    <measurement group_id="O2" value="4.22" spread="3.24"/>
                    <measurement group_id="O3" value="3.62" spread="3.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.93" spread="2.76"/>
                    <measurement group_id="O2" value="3.72" spread="2.55"/>
                    <measurement group_id="O3" value="3.52" spread="2.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.47" spread="2.52"/>
                    <measurement group_id="O2" value="2.81" spread="2.51"/>
                    <measurement group_id="O3" value="3.38" spread="2.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Level assessed by the Visual Analog Scale (VAS) Score Post surgery (POD 3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.08" spread="2.94"/>
                    <measurement group_id="O2" value="3.35" spread="2.15"/>
                    <measurement group_id="O3" value="3.41" spread="2.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Level assessed by the Visual Analog Scale Score Post surgery (follow up visit - Up to 6 weeks)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="2.58"/>
                    <measurement group_id="O2" value="3.09" spread="2.68"/>
                    <measurement group_id="O3" value="3.00" spread="2.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mini Cog Score</title>
        <description>The Mini-Cog is a 3-minute instrument that can increase detection of cognitive impairment. A score ranging from 0-2 indicates positive screen for dementia. A score ranging from 3-5 indicates negative screen for dementia.</description>
        <time_frame>Baseline, Post Surgery (Up to 6 Weeks)</time_frame>
        <population>The number of participants is different from participant flow because some of the subjects did not complete the assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Ketamine 0.5 mg/kg</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg.&#xD;
Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
          <group group_id="O2">
            <title>Ketamine 1.0 mg/kg</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg.&#xD;
Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo.&#xD;
Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mini Cog Score</title>
          <description>The Mini-Cog is a 3-minute instrument that can increase detection of cognitive impairment. A score ranging from 0-2 indicates positive screen for dementia. A score ranging from 3-5 indicates negative screen for dementia.</description>
          <population>The number of participants is different from participant flow because some of the subjects did not complete the assessment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Mini Cog Score- Positive Screen</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Mini Cog Score- Negative Screen</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mini Cog Score Post surgery (Up to 6 weeks) - Positive Screen</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mini Cog Score Post surgery (Up to 6 weeks) - Negative Screen</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mini-Mental Status Examination (MMSE) Score</title>
        <description>The MMSE is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this (0-24), scores can indicate cognitive impairment.</description>
        <time_frame>Baseline, Post Surgery (Up to 6 Weeks)</time_frame>
        <population>This assessment was not completed for some subjects, and that is the reason why the number analyzed is different from the overall number analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Ketamine 0.5 mg/kg</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg.&#xD;
Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
          <group group_id="O2">
            <title>Ketamine 1.0 mg/kg</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg.&#xD;
Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo.&#xD;
Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mini-Mental Status Examination (MMSE) Score</title>
          <description>The MMSE is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this (0-24), scores can indicate cognitive impairment.</description>
          <population>This assessment was not completed for some subjects, and that is the reason why the number analyzed is different from the overall number analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Normal Baseline MMSE Score (25-30)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cognitive Impairment Baseline MMSE Score (0-24)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal Post surgery (Up to 6 weeks) MMSE Score (25-30)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cognitive Impairment Post surgery (Up to 6 weeks) MMSE Score (0-24)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cognitive Failure Questionnaire (CFQ) Score</title>
        <description>The CFQ is a 25-item self-report measure of failures in attention, perception, memory, and action. Participants are asked to indicate on a 5-point scale how often they have experienced each failure in the past months, from 0 (never) to 5 (very often). Scores range from 0 to 100 a higher score indicating more failures in attention.</description>
        <time_frame>Baseline, Post Surgery (Up to 6 Weeks)</time_frame>
        <population>This assessment was not completed for some subjects, and that is the reason why the number analyzed is different from the overall number analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Ketamine 0.5 mg/kg</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg.&#xD;
Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
          <group group_id="O2">
            <title>Ketamine 1.0 mg/kg</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg.&#xD;
Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo.&#xD;
Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cognitive Failure Questionnaire (CFQ) Score</title>
          <description>The CFQ is a 25-item self-report measure of failures in attention, perception, memory, and action. Participants are asked to indicate on a 5-point scale how often they have experienced each failure in the past months, from 0 (never) to 5 (very often). Scores range from 0 to 100 a higher score indicating more failures in attention.</description>
          <population>This assessment was not completed for some subjects, and that is the reason why the number analyzed is different from the overall number analyzed.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="25"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline CFQ Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27" lower_limit="21" upper_limit="38"/>
                    <measurement group_id="O2" value="34" lower_limit="22" upper_limit="40"/>
                    <measurement group_id="O3" value="30" lower_limit="21.5" upper_limit="38.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFQ Score Post surgery (Up to 6 weeks)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29" lower_limit="23" upper_limit="35"/>
                    <measurement group_id="O2" value="30" lower_limit="15" upper_limit="40"/>
                    <measurement group_id="O3" value="29" lower_limit="23" upper_limit="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post Operative Narcotics Use</title>
        <description>The total amount of narcotics used measured in morphine milligram equivalents (MME).</description>
        <time_frame>Post Intervention (Intraoperative), Post Intervention (POD 0), Post Intervention (POD 1),Post Intervention (POD 2),Post Intervention (POD 3), Post Intervention (Follow up visit-up to 6 weeks post intervention)</time_frame>
        <population>The population is different at 6 weeks post intervention because this outcome was not completed for some participants at that time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Ketamine 0.5 mg/kg</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg.&#xD;
Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
          <group group_id="O2">
            <title>Ketamine 1.0 mg/kg</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg.&#xD;
Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo.&#xD;
Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
        </group_list>
        <measure>
          <title>Post Operative Narcotics Use</title>
          <description>The total amount of narcotics used measured in morphine milligram equivalents (MME).</description>
          <population>The population is different at 6 weeks post intervention because this outcome was not completed for some participants at that time point.</population>
          <units>morphine milligram equivalents (MME)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post Intervention (Intraoperative)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3" lower_limit="6.7" upper_limit="13.33"/>
                    <measurement group_id="O2" value="13.3" lower_limit="10.0" upper_limit="20.0"/>
                    <measurement group_id="O3" value="13.33" lower_limit="8.75" upper_limit="16.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Intervention (POD 0)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" lower_limit="0" upper_limit="11.9"/>
                    <measurement group_id="O2" value="6.67" lower_limit="0" upper_limit="11.9"/>
                    <measurement group_id="O3" value="6.18" lower_limit="3.3" upper_limit="15.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Intervention (POD 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35" lower_limit="10.7" upper_limit="57.7"/>
                    <measurement group_id="O2" value="41.5" lower_limit="27.1" upper_limit="91.4"/>
                    <measurement group_id="O3" value="42.9" lower_limit="25.7" upper_limit="51.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Intervention (POD 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.59" lower_limit="2.0" upper_limit="53.8"/>
                    <measurement group_id="O2" value="25.7" lower_limit="10.0" upper_limit="78.6"/>
                    <measurement group_id="O3" value="41.9" lower_limit="17.3" upper_limit="51.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Intervention (POD 3)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.8" lower_limit="0.0" upper_limit="40.8"/>
                    <measurement group_id="O2" value="34.3" lower_limit="2.0" upper_limit="50.7"/>
                    <measurement group_id="O3" value="34.3" lower_limit="17.1" upper_limit="44.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Intervention (Follow up visit-up to 6 weeks)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="8.6"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="38.4"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="25.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Associations of Intraoperative EEG Patterns With PACU Delirium</title>
        <description>The investigators compared the relative beta power derived from the normalized power spectral density (PSD) in patients with and without PACU delirium (positive and negative delirium). Only a total of 38 EEGs with sufficient quality were analyzed. Results are expressed in percentage of cumulative power. A higher beta power correlates with worse outcome. Averages and standard deviations are shown.</description>
        <time_frame>Intraoperative EEG and delirium during PACU stay</time_frame>
        <population>Only a total of 38 EEGs with sufficient quality were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Ketamine 0.5 mg/kg</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 0.5 mg/kg.&#xD;
Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
          <group group_id="O2">
            <title>Ketamine 1.0 mg/kg</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV ketamine at 1.0 mg/kg.&#xD;
Ketamine: Ketamine was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants undergoing surgery for otolaryngeal cancer were randomized to receive one dose of IV saline/placebo.&#xD;
Placebo: Placebo was administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device was used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
          </group>
        </group_list>
        <measure>
          <title>Associations of Intraoperative EEG Patterns With PACU Delirium</title>
          <description>The investigators compared the relative beta power derived from the normalized power spectral density (PSD) in patients with and without PACU delirium (positive and negative delirium). Only a total of 38 EEGs with sufficient quality were analyzed. Results are expressed in percentage of cumulative power. A higher beta power correlates with worse outcome. Averages and standard deviations are shown.</description>
          <population>Only a total of 38 EEGs with sufficient quality were analyzed</population>
          <units>Percentage of cumulative power</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Positive Delirium for PACU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" spread="5.0"/>
                    <measurement group_id="O2" value="7.0" spread="5.0"/>
                    <measurement group_id="O3" value="7.0" spread="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative Delirium for PACU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" spread="1.0"/>
                    <measurement group_id="O2" value="5.0" spread="6.0"/>
                    <measurement group_id="O3" value="6.0" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively.</time_frame>
      <desc>If the change from baseline was considered by the investigator to be part of the normal fluctuations of an underlying disease process, this was not reported as an adverse event (AE). If the change in baseline was considered by the investigator to be an untoward medical occurrence different from the standard of care, this medical occurrence was reported as an AE.</desc>
      <group_list>
        <group group_id="E1">
          <title>Ketamine 0.5 mg/kg</title>
          <description>Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg.&#xD;
Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
        </group>
        <group group_id="E2">
          <title>Ketamine 1.0 mg/kg</title>
          <description>Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg.&#xD;
Ketamine: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo.&#xD;
Placebo: Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.&#xD;
Electroencephalogram (EEG): A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>NSTEMI</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Surgical wound dehiscence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Post-operative wound abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Partial flap necrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Exposed tendon of left forearm free flap</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Bilateral MCA; PCA transcortical acute infarcts</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Facial artery clot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Carotid injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="26"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Transient left sided weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hallucinations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Amit Prabhakar</name_or_title>
      <organization>Emory University</organization>
      <phone>404-686-2747</phone>
      <email>amit.prabhakar@emory.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03040024
org study id: IRB00086609
nct id: NCT03040024
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The goal of this prospective randomized double blinded placebo controlled study is to
      investigate if a single dose of ketamine in addition to standard anesthesia will reduce the
      risk of delirium in otolaryngeal cancer patients postoperatively. Ketamine's effect on
      post-operative pain and opioid use will be measured as well. Electroencephalogram (EEG) will
      be utilized during the surgical procedure to evaluate its potential as a possible predictive
      device for delirium.
This is a single center prospective randomized double blinded placebo controlled study.

      The primary aim of the study is to optimize the intraoperative treatment protocol for head
      and neck cancer patients to reduce the incidence of delirium and associated postoperative
      cognitive dysfunction. Secondary aims are to determine the dose response relationship for
      intraoperative ketamine and delirium reduction, determine if a single dose of ketamine will
      reduce post-operative pain and opioid requirements, determine if raw electroencephalogram
      (EEG) data can predict postoperative delirium during general anesthesia, and to evaluate
      length of intensive care unit (ICU) and length of hospital stay.

      Participants will be randomized to one of three groups after administration of general
      anesthesia; one dose of .5 mg/kg intravenous (IV) Ketamine, 1.0 mg/kg of IV Ketamine, or IV
      placebo.

      An EEG will be used during the surgical procedure to gather raw data for off line analysis
      among patients developing post-operative delirium.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score
time frame: Baseline (Up to 30 minutes after PACU arrival), Post Operative (PACU discharge up to 6 hours)
description: The CAM-ICU assesses four features: 1) acute change or fluctuation in mental status from baseline, 2) inattention, 3) altered level of consciousness, and 4) disorganized thinking. The measure reports whether a participant meets criteria for delirium by summing the number of features answered as "present". Feature 1 plus 2 and either 3 or 4 present = delirium positive. Results are expressed as number of participants with or without delirium at each time frame.
measure: Change in Behavioral Pain Scale (Non-Intubated) Score
time frame: Post Operation (Up to 6 Hours), Post Operation Day 0
description: The Behavioral Pain Scale. Scores range from 3 (no pain) to 12 (maximum pain).
measure: Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score
time frame: Baseline, Post Surgery (PACU), Post surgery (POD 0), Post surgery (POD 1), Post surgery (POD 2), Post surgery (POD 3), Post surgery (follow up visit - Up to 6 weeks)
description: Scores range from 0 (no pain) to 10 (worst pain).
measure: Change in Mini Cog Score
time frame: Baseline, Post Surgery (Up to 6 Weeks)
description: The Mini-Cog is a 3-minute instrument that can increase detection of cognitive impairment. A score ranging from 0-2 indicates positive screen for dementia. A score ranging from 3-5 indicates negative screen for dementia.
measure: Change in Mini-Mental Status Examination (MMSE) Score
time frame: Baseline, Post Surgery (Up to 6 Weeks)
description: The MMSE is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this (0-24), scores can indicate cognitive impairment.
measure: Change in Cognitive Failure Questionnaire (CFQ) Score
time frame: Baseline, Post Surgery (Up to 6 Weeks)
description: The CFQ is a 25-item self-report measure of failures in attention, perception, memory, and action. Participants are asked to indicate on a 5-point scale how often they have experienced each failure in the past months, from 0 (never) to 5 (very often). Scores range from 0 to 100 a higher score indicating more failures in attention.
measure: Post Operative Narcotics Use
time frame: Post Intervention (Intraoperative), Post Intervention (POD 0), Post Intervention (POD 1),Post Intervention (POD 2),Post Intervention (POD 3), Post Intervention (Follow up visit-up to 6 weeks post intervention)
description: The total amount of narcotics used measured in morphine milligram equivalents (MME).
measure: Associations of Intraoperative EEG Patterns With PACU Delirium
time frame: Intraoperative EEG and delirium during PACU stay
description: The investigators compared the relative beta power derived from the normalized power spectral density (PSD) in patients with and without PACU delirium (positive and negative delirium). Only a total of 38 EEGs with sufficient quality were analyzed. Results are expressed in percentage of cumulative power. A higher beta power correlates with worse outcome. Averages and standard deviations are shown.
arm group label: Ketamine 0.5 mg/kg
arm group type: Experimental
description: Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg.
arm group label: Ketamine 1.0 mg/kg
arm group type: Experimental
description: Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo.
intervention type: Drug
intervention name: Ketamine
description: Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.
arm group label: Ketamine 0.5 mg/kg
arm group label: Ketamine 1.0 mg/kg
intervention type: Drug
intervention name: Placebo
description: Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.
arm group label: Placebo
other name: Saline Solution
intervention type: Device
intervention name: Electroencephalogram (EEG)
description: A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.
arm group label: Ketamine 0.5 mg/kg
arm group label: Ketamine 1.0 mg/kg
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vanessa Moll, PhD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Amit Prabhakar
investigator title: Assistant Professor
mesh term: Delirium
mesh term: Ketamine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 