<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/NCT02988219</url>
  </required_header>
  <id_info>
    <org_study_id>U/1/2010</org_study_id>
    <nct_id>NCT02988219</nct_id>
  </id_info>
  <brief_title>Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method</brief_title>
  <official_title>Evaluation of Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the incidence of cardiac arrhythmias during the perioperative period in&#xD;
      patients undergoing open kidney cancer surgery in the lateral position. All the participants&#xD;
      will be randomly allocated to receive general (Group G) or combined epidural/general&#xD;
      anaesthesia (Group G/E). The anaesthetic technique is standardized. The Holter monitor will&#xD;
      be applied at the evening before the surgery, tracing continuously for a period of 24 hours&#xD;
      (7PM-7PM)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiac arrhythmias are a common complication during and after cardio-thoracic surgery. They&#xD;
      are also a major source of morbidity and mortality. After general surgery, they usually do&#xD;
      not require clinically significant management but the literature on this topic is obsolete.&#xD;
      There is no literature data about their incidence during kidney surgery in the lateral&#xD;
      position when the bed is scissored so the legs and head are low. The aim of this study was to&#xD;
      define what types of arrhythmias are the most common during kidney cancer surgery, their&#xD;
      incidence and whether combining general with epidural anesthesia prevents them.&#xD;
&#xD;
      An approval from the Medical University of Warsaw Bioethical Committee has been obtained.&#xD;
      Patients need to give written informed consent to participate in the study.&#xD;
&#xD;
      It is anticipated that 50 patients with open kidney cancer surgery performed in the lateral&#xD;
      position, under general or combined anesthesia will be enrolled.&#xD;
&#xD;
      A Holter ECG monitor (3-chanel, leads CM5) will be applied at the evening before the surgery,&#xD;
      tracing continuously for a period of 24 hours (7PM-7PM).&#xD;
&#xD;
      Patients will be randomly allocated (random permuted blocks within strata) to receive general&#xD;
      or combined epidural/general anesthesia. The anesthetic technique is standardized. All the&#xD;
      data registered by the Holter ECG monitor will be analyzed and compared with the nursery and&#xD;
      anesthesia records.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2010</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period</measure>
    <time_frame>60 months</time_frame>
    <description>The investigator evaluates the incidence of cardiac arrhythmias, the type of arrhythmias and whether additional interventions were needed to treat them&#xD;
Arrhythmias observed:&#xD;
tachycardia &gt;100 bpm bradycardia &lt; 50 bpm pause (P-P interval &gt; 2 seconds) ventricular extrasystoles (VE) &gt; 1000/ 24 hours supraventricular extrasystoles (SVE) &gt;200/24 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed</measure>
    <time_frame>60 months</time_frame>
    <description>The investigator evaluates the incidence of cardiac arrhythmias depending on anesthesia method by observing the number and type of arrhythmias and whether additional interventions were needed to treat them</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Arrhythmia, Cardiac</condition>
  <condition>Kidney Cancer</condition>
  <condition>Surgery</condition>
  <condition>Anesthesia, Local</condition>
  <arm_group>
    <arm_group_label>General anesthesia (G)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Holter ECG monitor General anesthesia Open kidney cancer surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combined general/epidural (G/E)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine-fentanyl</intervention_name>
    <description>Local anesthetic</description>
    <arm_group_label>Combined general/epidural (G/E)</arm_group_label>
    <other_name>Marcaine</other_name>
    <other_name>Sensorcaine</other_name>
    <other_name>Astra Zeneca</other_name>
    <other_name>Bupivacaine-epinephrine</other_name>
    <other_name>Fentanyl</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Holter ECG monitor</intervention_name>
    <description>3-chanel, CM5 leads</description>
    <arm_group_label>Combined general/epidural (G/E)</arm_group_label>
    <arm_group_label>General anesthesia (G)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open kidney cancer surgery</intervention_name>
    <description>Lateral position</description>
    <arm_group_label>Combined general/epidural (G/E)</arm_group_label>
    <arm_group_label>General anesthesia (G)</arm_group_label>
    <other_name>nephron sparing surgery (NSS)</other_name>
    <other_name>Radical nephrectomy</other_name>
    <other_name>Extraperitoneal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>General anesthesia</intervention_name>
    <arm_group_label>Combined general/epidural (G/E)</arm_group_label>
    <arm_group_label>General anesthesia (G)</arm_group_label>
    <other_name>Intubation</other_name>
    <other_name>Fentanyl</other_name>
    <other_name>Narcosis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Epidural Anaesthesia</intervention_name>
    <arm_group_label>Combined general/epidural (G/E)</arm_group_label>
    <other_name>Bupivacaine</other_name>
    <other_name>Epidural catheter</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Open renal cell carcinoma surgery, lateral position&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical grade I-III&#xD;
&#xD;
          -  No history of cardiac arrhythmias&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy and breast feeding&#xD;
&#xD;
          -  Contraindications for epidural anesthesia&#xD;
&#xD;
          -  Laparoscopic or robotic surgery&#xD;
&#xD;
          -  Suspected difficult intubation (ex. fibroscopic)&#xD;
&#xD;
          -  Chest deformations&#xD;
&#xD;
          -  Prior cardiac/thoracic surgery&#xD;
&#xD;
          -  Cardiac insufficiency&#xD;
&#xD;
          -  abnormal ECG before the surgery&#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>Karolina Dobronska, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>I Department of Anaesthesiology and Intensive Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw</name>
      <address>
        <city>Warsaw</city>
        <zip>02-005</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <results_first_submitted>January 16, 2017</results_first_submitted>
  <results_first_submitted_qc>March 14, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 25, 2017</results_first_posted>
  <last_update_submitted>April 25, 2017</last_update_submitted>
  <last_update_submitted_qc>April 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Warsaw</investigator_affiliation>
    <investigator_full_name>Karolina Dobrońska</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>cardiac arrhythmia</keyword>
  <keyword>epidural anesthesia</keyword>
  <keyword>combined anesthesia</keyword>
  <keyword>general anesthesia</keyword>
  <keyword>NSS</keyword>
  <keyword>radical nephrectomy</keyword>
  <keyword>extraperitoneal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>General Anesthesia (G)</title>
          <description>General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position</description>
        </group>
        <group group_id="P2">
          <title>Combined General/Epidural (G/E)</title>
          <description>General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>General Anesthesia (G)</title>
          <description>General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position</description>
        </group>
        <group group_id="B2">
          <title>Combined General/Epidural (G/E)</title>
          <description>General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position</description>
        </group>
        <group group_id="B3">
          <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="24"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="46"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61" spread="8.50"/>
                    <measurement group_id="B2" value="57" spread="9.04"/>
                    <measurement group_id="B3" value="59" spread="8.58"/>
                  </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="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </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>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <description>Body Mass Index</description>
          <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="28.14" spread="4.84"/>
                    <measurement group_id="B2" value="30.04" spread="7.01"/>
                    <measurement group_id="B3" value="29.29" spread="5.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ASA</title>
          <description>AMERICAN SOCIETY OF ANESTHESIOLOGISTASA (ASA) PHYSICAL STATUS CLASSIFICATION SYSTEM&#xD;
ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes&#xD;
*The addition of &quot;E&quot; denotes Emergency surgery</description>
          <units>scores on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="B2" value="2" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="B3" value="2" lower_limit="1" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of Surgery</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>NSS</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nefrectomy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period</title>
        <description>The investigator evaluates the incidence of cardiac arrhythmias, the type of arrhythmias and whether additional interventions were needed to treat them&#xD;
Arrhythmias observed:&#xD;
tachycardia &gt;100 bpm bradycardia &lt; 50 bpm pause (P-P interval &gt; 2 seconds) ventricular extrasystoles (VE) &gt; 1000/ 24 hours supraventricular extrasystoles (SVE) &gt;200/24 hours</description>
        <time_frame>60 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>General Anesthesia (G)</title>
            <description>General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position</description>
          </group>
          <group group_id="O2">
            <title>Combined General/Epidural (G/E)</title>
            <description>General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position General anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period</title>
          <description>The investigator evaluates the incidence of cardiac arrhythmias, the type of arrhythmias and whether additional interventions were needed to treat them&#xD;
Arrhythmias observed:&#xD;
tachycardia &gt;100 bpm bradycardia &lt; 50 bpm pause (P-P interval &gt; 2 seconds) ventricular extrasystoles (VE) &gt; 1000/ 24 hours supraventricular extrasystoles (SVE) &gt;200/24 hours</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Tachycardia &lt; 140 bpm before surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tachycardia &lt; 140 bpm during surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tachycardia &lt; 140 bpm after surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bradycardia before surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bradycardia during surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bradycardia after surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bradycardia in the perioperative period</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>pause &gt; 2s before surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>pause &gt; 2s during surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>pause &gt; 2s after surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>pause &gt; 2s in the perioperative period</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SVE before surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SVE during surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SVE after surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SVE in the perioperativ</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VE before surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VE during surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VE after surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VE in the perioperative period</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Additional intervention needed</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Bradycardia during surgery</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3861</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>No bradycardia observed in the perioperative period</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2591</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed</title>
        <description>The investigator evaluates the incidence of cardiac arrhythmias depending on anesthesia method by observing the number and type of arrhythmias and whether additional interventions were needed to treat them</description>
        <time_frame>60 months</time_frame>
        <population>arrhythmias analysed: bradycardia, pause &gt; 2s, supraventricular extrasystoles, ventricular extrasystoles; corrected QT interval (QTc)</population>
        <group_list>
          <group group_id="O1">
            <title>General Anesthesia (G)</title>
            <description>General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position</description>
          </group>
          <group group_id="O2">
            <title>Combined General/Epidural (G/E)</title>
            <description>General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position General anesthesia</description>
          </group>
        </group_list>
        <measure>
          <title>The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed</title>
          <description>The investigator evaluates the incidence of cardiac arrhythmias depending on anesthesia method by observing the number and type of arrhythmias and whether additional interventions were needed to treat them</description>
          <population>arrhythmias analysed: bradycardia, pause &gt; 2s, supraventricular extrasystoles, ventricular extrasystoles; corrected QT interval (QTc)</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="24"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>arrhythmia before surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>arrhythmia during surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>arrhythmia after surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTc long &gt; 0.45s before surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTc long &gt; 0.45s during surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTc long &gt; 0.45s after surgery</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTc long &gt; 0.45s in the perioperative time</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Additional intervention needed</title>
              <category_list>
                <category>
                  <title>observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not observed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Arrhythmia before surgery</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.597</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>arrhythmia during surgery</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>arrhythmia after surgery</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.6544</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>long QTc &gt; 0.45s after surgery</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.077</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>long QTc &gt; 0.24 s in the perioperative time</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0174</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>General Anesthesia (G)</title>
          <description>General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position</description>
        </group>
        <group group_id="E2">
          <title>Combined General/Epidural (G/E)</title>
          <description>General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position</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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </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. Karolina Dobronska</name_or_title>
      <organization>Warsaw Medical University</organization>
      <phone>48 22 502 17 21</phone>
      <email>karolinapladzyk@gmail.com</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/NCT02988219
org study id: U/1/2010
nct id: NCT02988219
lead sponsor: 
has dmc: No
This study evaluates the incidence of cardiac arrhythmias during the perioperative period in
      patients undergoing open kidney cancer surgery in the lateral position. All the participants
      will be randomly allocated to receive general (Group G) or combined epidural/general
      anaesthesia (Group G/E). The anaesthetic technique is standardized. The Holter monitor will
      be applied at the evening before the surgery, tracing continuously for a period of 24 hours
      (7PM-7PM)
Cardiac arrhythmias are a common complication during and after cardio-thoracic surgery. They
      are also a major source of morbidity and mortality. After general surgery, they usually do
      not require clinically significant management but the literature on this topic is obsolete.
      There is no literature data about their incidence during kidney surgery in the lateral
      position when the bed is scissored so the legs and head are low. The aim of this study was to
      define what types of arrhythmias are the most common during kidney cancer surgery, their
      incidence and whether combining general with epidural anesthesia prevents them.

      An approval from the Medical University of Warsaw Bioethical Committee has been obtained.
      Patients need to give written informed consent to participate in the study.

      It is anticipated that 50 patients with open kidney cancer surgery performed in the lateral
      position, under general or combined anesthesia will be enrolled.

      A Holter ECG monitor (3-chanel, leads CM5) will be applied at the evening before the surgery,
      tracing continuously for a period of 24 hours (7PM-7PM).

      Patients will be randomly allocated (random permuted blocks within strata) to receive general
      or combined epidural/general anesthesia. The anesthetic technique is standardized. All the
      data registered by the Holter ECG monitor will be analyzed and compared with the nursery and
      anesthesia records.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
time frame: 60 months
description: The investigator evaluates the incidence of cardiac arrhythmias, the type of arrhythmias and whether additional interventions were needed to treat them
Arrhythmias observed:
tachycardia >100 bpm bradycardia < 50 bpm pause (P-P interval > 2 seconds) ventricular extrasystoles (VE) > 1000/ 24 hours supraventricular extrasystoles (SVE) >200/24 hours
measure: The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed
time frame: 60 months
description: The investigator evaluates the incidence of cardiac arrhythmias depending on anesthesia method by observing the number and type of arrhythmias and whether additional interventions were needed to treat them
arm group label: General anesthesia (G)
arm group type: Active Comparator
description: Holter ECG monitor General anesthesia Open kidney cancer surgery
arm group label: Combined general/epidural (G/E)
arm group type: Experimental
description: Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery
intervention type: Drug
intervention name: Bupivacaine-fentanyl
description: Local anesthetic
arm group label: Combined general/epidural (G/E)
other name: Marcaine
other name: Sensorcaine
other name: Astra Zeneca
other name: Bupivacaine-epinephrine
other name: Fentanyl
intervention type: Device
intervention name: Holter ECG monitor
description: 3-chanel, CM5 leads
arm group label: Combined general/epidural (G/E)
arm group label: General anesthesia (G)
intervention type: Procedure
intervention name: Open kidney cancer surgery
description: Lateral position
arm group label: Combined general/epidural (G/E)
arm group label: General anesthesia (G)
other name: nephron sparing surgery (NSS)
other name: Radical nephrectomy
other name: Extraperitoneal
intervention type: Procedure
intervention name: General anesthesia
arm group label: Combined general/epidural (G/E)
arm group label: General anesthesia (G)
other name: Intubation
other name: Fentanyl
other name: Narcosis
intervention type: Procedure
intervention name: Epidural Anaesthesia
arm group label: Combined general/epidural (G/E)
other name: Bupivacaine
other name: Epidural catheter
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karolina Dobronska, MD
role: Principal Investigator
affiliation: I Department of Anaesthesiology and Intensive Care
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Warsaw
investigator full name: Karolina Dobrońska
investigator title: M.D.
mesh term: Kidney Neoplasms
mesh term: Carcinoma, Renal Cell
mesh term: Arrhythmias, Cardiac
mesh term: Epinephrine
mesh term: Fentanyl
mesh term: Bupivacaine
mesh term: Anesthetics
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 