<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/NCT01717521</url>
  </required_header>
  <id_info>
    <org_study_id>42398</org_study_id>
    <nct_id>NCT01717521</nct_id>
  </id_info>
  <brief_title>Effects of IV Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris</brief_title>
  <official_title>The Effects of Intravenous Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates effects of the analgesic ketamine on ANI measurements (Anti Nociceptive&#xD;
      Index)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Researchers at the University of Washington are doing this study to find out if a commonly&#xD;
      used anesthetic affects patients Analgesia Nociception Index (level of pain relief) during&#xD;
      abdominal hysterectomy under general anesthesia.&#xD;
&#xD;
      The investigators will administer routine anesthesia care including Ketamine, a commonly used&#xD;
      anesthetic, during the patients surgery. During the patients surgery, the investigators will&#xD;
      monitor the patients level of pain relief using the PhysioDoloris monitor, which monitors the&#xD;
      routinely used EKG monitor. Though not yet FDA approved, the PhysioDoloris is completely&#xD;
      non-invasive and collects data from the EKG monitor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mean ANI Changes After Intubation</measure>
    <time_frame>Before vs after intubation</time_frame>
    <description>ANI stands for Analgesia Nociception Index. Its a dimension less number computed by a pain monitor ranging from 0-100. An index of 100 means absent pain, and the number decreases as pain increases. ANI was measured pre- and post- Intubation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean ANI Changes 3 Min After Ketamine Bolus</measure>
    <time_frame>Before vs 3 min after Ketamine adminstration</time_frame>
    <description>ANI was measured pre- and post- i.v. ketamine administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean ANI Changes 5 Min After Ketamine Bolus</measure>
    <time_frame>Before vs 5 min after Ketamine adminstration</time_frame>
    <description>ANI was measured pre- and post- i.v. ketamine administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean ANI Changes After Skin Incision</measure>
    <time_frame>Before vs after skin incision</time_frame>
    <description>ANI was measured pre- and post- skin incision</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean BIS Changes After Intubation</measure>
    <time_frame>Before vs after intubation</time_frame>
    <description>BIS was measured pre- and post-intubation.&#xD;
BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).&#xD;
100-90: awake and responding appropriately to verbal stimulation&#xD;
80-70: responsive to loud commands or mild shaking&#xD;
60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall&#xD;
&lt;40: deep hypnotic state; possible protective responses still intact&#xD;
&lt;20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact&#xD;
0: totally suppressed EEG (flat line)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean BIS Changes 3 Min After Ketamine Bolus</measure>
    <time_frame>Before vs 3 min after Ketamine adminstration</time_frame>
    <description>BIS was measured pre- and post-Ketamine administration.&#xD;
BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).&#xD;
100-90: awake and responding appropriately to verbal stimulation&#xD;
80-70: responsive to loud commands or mild shaking&#xD;
60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall&#xD;
&lt;40: deep hypnotic state; possible protective responses still intact&#xD;
&lt;20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact&#xD;
0: totally suppressed EEG (flat line)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean BIS Changes After Skin Incision</measure>
    <time_frame>Before vs after skin incision</time_frame>
    <description>BIS was measured pre- and post-skin incision.&#xD;
BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).&#xD;
100-90: awake and responding appropriately to verbal stimulation&#xD;
80-70: responsive to loud commands or mild shaking&#xD;
60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall&#xD;
&lt;40: deep hypnotic state; possible protective responses still intact&#xD;
&lt;20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact&#xD;
0: totally suppressed EEG (flat line)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Heart Rate Change After Intubation</measure>
    <time_frame>Before vs after intubation</time_frame>
    <description>Heart rate assessed by continuous pulse oximetry. Heart rate was measured pre- and post-intubation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Heart Rate Change 3 Min After Ketamine Bolus</measure>
    <time_frame>Before vs 3 min after Ketamine adminstration</time_frame>
    <description>Heart rate was measured pre- and post- Ketamine administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Heart Rate Change After Skin Incision</measure>
    <time_frame>Before vs after skin incision</time_frame>
    <description>Heart rate was measured pre- and post-skin incision.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mean Arterial Pressure After Intubation</measure>
    <time_frame>Before vs after intubation</time_frame>
    <description>MAP or mean arterial pressure is the average blood pressure of an individual and is measured non-invasively during surgery. MAP was measured pre- and post-intubation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus</measure>
    <time_frame>Before vs 3 min after Ketamine adminstration</time_frame>
    <description>MAP was measured pre- and post-ketamine administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean MAP Changes After Skin Incision</measure>
    <time_frame>Before vs after skin incision</time_frame>
    <description>MAP was measured pre- and post- skin incision.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Average Ketamine Used</measure>
    <time_frame>Surgery</time_frame>
    <description>Amount of Ketamine used during surgery</description>
  </other_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Monitoring, Intraoperative</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Women undergoing gynecological/abdominal surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA status I, II, or III&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Receiving GA with uncomplicated routine intubation&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of coronary artery disease, cardiac arrhythmias, or ketamine allergy&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  History of substance abuse&#xD;
&#xD;
          -  Patients taking psychotropic and/or opiate drugs&#xD;
&#xD;
          -  Having a history of psychiatric diseases or psychological problems&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laurent Bollag, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <results_first_submitted>December 2, 2014</results_first_submitted>
  <results_first_submitted_qc>June 24, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 5, 2019</results_first_posted>
  <last_update_submitted>June 24, 2019</last_update_submitted>
  <last_update_submitted_qc>June 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Laurent Bollag</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>intraoperative monitoring</keyword>
  <keyword>hysterectomy</keyword>
  <keyword>robotic-assisted</keyword>
  <keyword>abdominal gynecological surgery</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>After institutional review board approval, this observational pilot study was conducted at the University of Washington Medical Center (UWMC). Twenty women, 18 years of age or older, of American Society of Anesthesiology Physical Status I-III scheduled for an abdominal hysterectomy under sevoflurane anesthesia were recruited.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Women, Scheduled for Abdominal Hysterectomy</title>
          <description>Women 18 years of age or older, of American Society of Anesthesiology Physical Status I-III scheduled for an abdominal hysterectomy under general anesthesia</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Twenty women, 18 years of age or older, of American Society of Anesthesiology Physical Status I-III scheduled for an abdominal hysterectomy under sevoflurane anesthesia were recruited.</population>
      <group_list>
        <group group_id="B1">
          <title>Women Scheduled for Abdominal Hysterectomies.</title>
          <description>Inclusion criteria : &gt;18yrs, ASA 1-3, Scheduled for abdominal hysterectomies under general anesthesia</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </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="61.4" spread="11.13"/>
                  </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="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="162.3" spread="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82.3" spread="35.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.3" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean ANI Changes After Intubation</title>
        <description>ANI stands for Analgesia Nociception Index. Its a dimension less number computed by a pain monitor ranging from 0-100. An index of 100 means absent pain, and the number decreases as pain increases. ANI was measured pre- and post- Intubation</description>
        <time_frame>Before vs after intubation</time_frame>
        <population>This pilot study included 20 women undergoing abdominal hysterectomies</population>
        <group_list>
          <group group_id="O1">
            <title>Single Group</title>
            <description>Participants undergoing abdominal hysterectomy under sevoflurane anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Mean ANI Changes After Intubation</title>
          <description>ANI stands for Analgesia Nociception Index. Its a dimension less number computed by a pain monitor ranging from 0-100. An index of 100 means absent pain, and the number decreases as pain increases. ANI was measured pre- and post- Intubation</description>
          <population>This pilot study included 20 women undergoing abdominal hysterectomies</population>
          <units>index</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.11" spread="20.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean ANI Changes 3 Min After Ketamine Bolus</title>
        <description>ANI was measured pre- and post- i.v. ketamine administration</description>
        <time_frame>Before vs 3 min after Ketamine adminstration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Group</title>
            <description>Participants undergoing abdominal hysterectomy under sevoflurane anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Mean ANI Changes 3 Min After Ketamine Bolus</title>
          <description>ANI was measured pre- and post- i.v. ketamine administration</description>
          <units>index</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.31" spread="15.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean ANI Changes 5 Min After Ketamine Bolus</title>
        <description>ANI was measured pre- and post- i.v. ketamine administration</description>
        <time_frame>Before vs 5 min after Ketamine adminstration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Group</title>
            <description>Participants undergoing abdominal hysterectomy under sevoflurane anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Mean ANI Changes 5 Min After Ketamine Bolus</title>
          <description>ANI was measured pre- and post- i.v. ketamine administration</description>
          <units>index</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.95" spread="17.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean ANI Changes After Skin Incision</title>
        <description>ANI was measured pre- and post- skin incision</description>
        <time_frame>Before vs after skin incision</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Group</title>
            <description>Participants undergoing abdominal hysterectomy under sevoflurane anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Mean ANI Changes After Skin Incision</title>
          <description>ANI was measured pre- and post- skin incision</description>
          <units>index</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.65" spread="15.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean BIS Changes After Intubation</title>
        <description>BIS was measured pre- and post-intubation.&#xD;
BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).&#xD;
100-90: awake and responding appropriately to verbal stimulation&#xD;
80-70: responsive to loud commands or mild shaking&#xD;
60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall&#xD;
&lt;40: deep hypnotic state; possible protective responses still intact&#xD;
&lt;20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact&#xD;
0: totally suppressed EEG (flat line)</description>
        <time_frame>Before vs after intubation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Group</title>
            <description>Participants undergoing abdominal hysterectomy under sevoflurane anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Mean BIS Changes After Intubation</title>
          <description>BIS was measured pre- and post-intubation.&#xD;
BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).&#xD;
100-90: awake and responding appropriately to verbal stimulation&#xD;
80-70: responsive to loud commands or mild shaking&#xD;
60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall&#xD;
&lt;40: deep hypnotic state; possible protective responses still intact&#xD;
&lt;20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact&#xD;
0: totally suppressed EEG (flat line)</description>
          <units>score 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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.25" spread="20.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean BIS Changes 3 Min After Ketamine Bolus</title>
        <description>BIS was measured pre- and post-Ketamine administration.&#xD;
BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).&#xD;
100-90: awake and responding appropriately to verbal stimulation&#xD;
80-70: responsive to loud commands or mild shaking&#xD;
60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall&#xD;
&lt;40: deep hypnotic state; possible protective responses still intact&#xD;
&lt;20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact&#xD;
0: totally suppressed EEG (flat line)</description>
        <time_frame>Before vs 3 min after Ketamine adminstration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Group</title>
            <description>Participants undergoing abdominal hysterectomy under sevoflurane anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Mean BIS Changes 3 Min After Ketamine Bolus</title>
          <description>BIS was measured pre- and post-Ketamine administration.&#xD;
BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).&#xD;
100-90: awake and responding appropriately to verbal stimulation&#xD;
80-70: responsive to loud commands or mild shaking&#xD;
60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall&#xD;
&lt;40: deep hypnotic state; possible protective responses still intact&#xD;
&lt;20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact&#xD;
0: totally suppressed EEG (flat line)</description>
          <units>score 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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="10.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean BIS Changes After Skin Incision</title>
        <description>BIS was measured pre- and post-skin incision.&#xD;
BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).&#xD;
100-90: awake and responding appropriately to verbal stimulation&#xD;
80-70: responsive to loud commands or mild shaking&#xD;
60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall&#xD;
&lt;40: deep hypnotic state; possible protective responses still intact&#xD;
&lt;20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact&#xD;
0: totally suppressed EEG (flat line)</description>
        <time_frame>Before vs after skin incision</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Group</title>
            <description>Participants undergoing abdominal hysterectomy under sevoflurane anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Mean BIS Changes After Skin Incision</title>
          <description>BIS was measured pre- and post-skin incision.&#xD;
BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).&#xD;
100-90: awake and responding appropriately to verbal stimulation&#xD;
80-70: responsive to loud commands or mild shaking&#xD;
60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall&#xD;
&lt;40: deep hypnotic state; possible protective responses still intact&#xD;
&lt;20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact&#xD;
0: totally suppressed EEG (flat line)</description>
          <units>score 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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="5.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Heart Rate Change After Intubation</title>
        <description>Heart rate assessed by continuous pulse oximetry. Heart rate was measured pre- and post-intubation.</description>
        <time_frame>Before vs after intubation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Group</title>
            <description>Participants undergoing abdominal hysterectomy under sevoflurane anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Heart Rate Change After Intubation</title>
          <description>Heart rate assessed by continuous pulse oximetry. Heart rate was measured pre- and post-intubation.</description>
          <units>bpm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Heart Rate Change 3 Min After Ketamine Bolus</title>
        <description>Heart rate was measured pre- and post- Ketamine administration</description>
        <time_frame>Before vs 3 min after Ketamine adminstration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Group</title>
            <description>Participants undergoing abdominal hysterectomy under sevoflurane anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Heart Rate Change 3 Min After Ketamine Bolus</title>
          <description>Heart rate was measured pre- and post- Ketamine administration</description>
          <units>bpm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Heart Rate Change After Skin Incision</title>
        <description>Heart rate was measured pre- and post-skin incision.</description>
        <time_frame>Before vs after skin incision</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Group</title>
            <description>Participants undergoing abdominal hysterectomy under sevoflurane anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Heart Rate Change After Skin Incision</title>
          <description>Heart rate was measured pre- and post-skin incision.</description>
          <units>bpm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean Arterial Pressure After Intubation</title>
        <description>MAP or mean arterial pressure is the average blood pressure of an individual and is measured non-invasively during surgery. MAP was measured pre- and post-intubation.</description>
        <time_frame>Before vs after intubation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Group</title>
            <description>Participants undergoing abdominal hysterectomy under sevoflurane anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Arterial Pressure After Intubation</title>
          <description>MAP or mean arterial pressure is the average blood pressure of an individual and is measured non-invasively during surgery. MAP was measured pre- and post-intubation.</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.05" spread="19.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus</title>
        <description>MAP was measured pre- and post-ketamine administration</description>
        <time_frame>Before vs 3 min after Ketamine adminstration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Group</title>
            <description>Participants undergoing abdominal hysterectomy under sevoflurane anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus</title>
          <description>MAP was measured pre- and post-ketamine administration</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.09" spread="18.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean MAP Changes After Skin Incision</title>
        <description>MAP was measured pre- and post- skin incision.</description>
        <time_frame>Before vs after skin incision</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Group</title>
            <description>Participants undergoing abdominal hysterectomy under sevoflurane anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Mean MAP Changes After Skin Incision</title>
          <description>MAP was measured pre- and post- skin incision.</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.5" spread="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Average Ketamine Used</title>
        <description>Amount of Ketamine used during surgery</description>
        <time_frame>Surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Group</title>
            <description>Participants undergoing abdominal hysterectomy under sevoflurane anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Average Ketamine Used</title>
          <description>Amount of Ketamine used during surgery</description>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.3" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Single Group w Intervention</title>
          <description>no adverse events were observed</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </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. Laurent Bollag</name_or_title>
      <organization>UWMC</organization>
      <phone>2063277328</phone>
      <email>bollag@uw.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/NCT01717521
org study id: 42398
nct id: NCT01717521
lead sponsor: 
has dmc: Yes
This study evaluates effects of the analgesic ketamine on ANI measurements (Anti Nociceptive
      Index)
Researchers at the University of Washington are doing this study to find out if a commonly
      used anesthetic affects patients Analgesia Nociception Index (level of pain relief) during
      abdominal hysterectomy under general anesthesia.

      The investigators will administer routine anesthesia care including Ketamine, a commonly used
      anesthetic, during the patients surgery. During the patients surgery, the investigators will
      monitor the patients level of pain relief using the PhysioDoloris monitor, which monitors the
      routinely used EKG monitor. Though not yet FDA approved, the PhysioDoloris is completely
      non-invasive and collects data from the EKG monitor.
observational model: Cohort
time perspective: Prospective
measure: Mean ANI Changes After Intubation
time frame: Before vs after intubation
description: ANI stands for Analgesia Nociception Index. Its a dimension less number computed by a pain monitor ranging from 0-100. An index of 100 means absent pain, and the number decreases as pain increases. ANI was measured pre- and post- Intubation
measure: Mean ANI Changes 3 Min After Ketamine Bolus
time frame: Before vs 3 min after Ketamine adminstration
description: ANI was measured pre- and post- i.v. ketamine administration
measure: Mean ANI Changes 5 Min After Ketamine Bolus
time frame: Before vs 5 min after Ketamine adminstration
description: ANI was measured pre- and post- i.v. ketamine administration
measure: Mean ANI Changes After Skin Incision
time frame: Before vs after skin incision
description: ANI was measured pre- and post- skin incision
measure: Mean BIS Changes After Intubation
time frame: Before vs after intubation
description: BIS was measured pre- and post-intubation.
BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).
100-90: awake and responding appropriately to verbal stimulation
80-70: responsive to loud commands or mild shaking
60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall
<40: deep hypnotic state; possible protective responses still intact
<20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact
0: totally suppressed EEG (flat line)
measure: Mean BIS Changes 3 Min After Ketamine Bolus
time frame: Before vs 3 min after Ketamine adminstration
description: BIS was measured pre- and post-Ketamine administration.
BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).
100-90: awake and responding appropriately to verbal stimulation
80-70: responsive to loud commands or mild shaking
60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall
<40: deep hypnotic state; possible protective responses still intact
<20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact
0: totally suppressed EEG (flat line)
measure: Mean BIS Changes After Skin Incision
time frame: Before vs after skin incision
description: BIS was measured pre- and post-skin incision.
BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).
100-90: awake and responding appropriately to verbal stimulation
80-70: responsive to loud commands or mild shaking
60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall
<40: deep hypnotic state; possible protective responses still intact
<20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact
0: totally suppressed EEG (flat line)
measure: Mean Heart Rate Change After Intubation
time frame: Before vs after intubation
description: Heart rate assessed by continuous pulse oximetry. Heart rate was measured pre- and post-intubation.
measure: Mean Heart Rate Change 3 Min After Ketamine Bolus
time frame: Before vs 3 min after Ketamine adminstration
description: Heart rate was measured pre- and post- Ketamine administration
measure: Mean Heart Rate Change After Skin Incision
time frame: Before vs after skin incision
description: Heart rate was measured pre- and post-skin incision.
measure: Change in Mean Arterial Pressure After Intubation
time frame: Before vs after intubation
description: MAP or mean arterial pressure is the average blood pressure of an individual and is measured non-invasively during surgery. MAP was measured pre- and post-intubation.
measure: Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus
time frame: Before vs 3 min after Ketamine adminstration
description: MAP was measured pre- and post-ketamine administration
measure: Mean MAP Changes After Skin Incision
time frame: Before vs after skin incision
description: MAP was measured pre- and post- skin incision.
measure: Average Ketamine Used
time frame: Surgery
description: Amount of Ketamine used during surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laurent Bollag, MD
role: Principal Investigator
affiliation: University of Washington
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Laurent Bollag
investigator title: Assistant Professor
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 