<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/NCT04467424</url>
  </required_header>
  <id_info>
    <org_study_id>Ketofol-Lidocaine</org_study_id>
    <nct_id>NCT04467424</nct_id>
  </id_info>
  <brief_title>Recovery After Total Intravenous Anesthesia With Ketofol Versus Mixture of Ketofol and Lidocaine for Short Pediatric Surgery</brief_title>
  <acronym>Lidoketofol</acronym>
  <official_title>TIVA With Ketofol Versus Lidoketofol for Short-term Anesthesia on Pediatric Patients; Effects on Recovery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital of Split</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital of Split</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Two hundred children aged 1-12 years undergoing short surgery will be randomized into two&#xD;
      groups. Ketofol will be used for induction and maintenance of anesthesia in group l. .Ketofol&#xD;
      with lidocaine will be prepared for group ll. A reducted McFarlan infusion dose will be used.&#xD;
      Extubating time, duration of anesthesia, length of stay in post-anesthesia care unit (PACU)&#xD;
      will be recorded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim of the research: In this study investigators want to examine the effectiveness of the use&#xD;
      of ketofol and a mixture of ketofol and lidocaine on the total consumption of opioids and on&#xD;
      the postoperative recovery of pediatric patients. Investigators will evaluate the safety,&#xD;
      efficacy, and outcomes of the anesthesia procedure with respect to the administration of&#xD;
      different anesthetics, specific pharmakocinetic profiles and compare the length of recovery&#xD;
      between patients in two groups.&#xD;
&#xD;
      Including criteria: children aged 1 to 12 years who underwent short surgery (up to 60 min).&#xD;
&#xD;
      Primary and secondary outcome measures: The primary outcome of this study will be extubation&#xD;
      time and the secondary outcome will be time spend in PACU.&#xD;
&#xD;
      Description of the study: Each subject included in the study will be given general anesthesia&#xD;
      with ketofol or ketofol and lidocaine, with the addition of fentanyl. After 20 s the LMA will&#xD;
      be placed. Maintenance of anesthesia will be performed using an air / oxygen mixture (50% /&#xD;
      50%) and an infusion of ketofol or ketofol and lidocaine. Ketofol will be prepare in a ratio&#xD;
      of 1: 4 for induction and 1: 7 for maintenance. The same mixtures of ketofol will be added 1&#xD;
      ml of 2% lidocaine for the second group of patients. After extubation, patients will be&#xD;
      transferred to the PACU.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 20, 2020</start_date>
  <completion_date type="Actual">December 18, 2020</completion_date>
  <primary_completion_date type="Actual">November 20, 2020</primary_completion_date>
  <phase>Phase 2</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>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children</measure>
    <time_frame>up to 600 seconds</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Length of Stay in the PACU</measure>
    <time_frame>up to 40 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption</measure>
    <time_frame>up to 60 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Surgical Procedure, Unspecified</condition>
  <arm_group>
    <arm_group_label>Pediatric anesthesia with ketofol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ketamine, propofol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pediatric anesthesia with ketofol plus lidocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ketamine, propofol, lidocaine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ketamine, propofol</intervention_name>
    <description>anesthesia with ketofol in pediatric surgery</description>
    <arm_group_label>Pediatric anesthesia with ketofol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ketamine, propofol, lidocaine</intervention_name>
    <description>anesthesia with ketofol plus lidocaine in pediatric surgery</description>
    <arm_group_label>Pediatric anesthesia with ketofol plus lidocaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  surgical procedures max 60 min ASA I and II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA &gt; II surgical procedures longer than 60 min&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital of Split</name>
      <address>
        <city>Split</city>
        <zip>21000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Croatia</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <results_first_submitted>November 11, 2020</results_first_submitted>
  <results_first_submitted_qc>January 15, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 4, 2021</results_first_posted>
  <last_update_submitted>January 15, 2021</last_update_submitted>
  <last_update_submitted_qc>January 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital of Split</investigator_affiliation>
    <investigator_full_name>Ana N Biliškov, MD</investigator_full_name>
    <investigator_title>Pediatric anesthesiologist</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Ketamine</mesh_term>
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 18, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT04467424/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pediatric Anesthesia With Ketofol</title>
          <description>ketamine, propofol&#xD;
ketamine, propofol: anesthesia with ketofol in pediatric surgery</description>
        </group>
        <group group_id="P2">
          <title>Pediatric Anesthesia With Ketofol Plus Lidocaine</title>
          <description>ketamine, propofol, lidocaine&#xD;
ketamine, propofol, lidocaine: anesthesia with ketofol plus lidocaine in pediatric surgery</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Age 1-12 years, male and female, for short surgery (max 60 min)</population>
      <group_list>
        <group group_id="B1">
          <title>Pediatric Anesthesia With Ketofol</title>
          <description>ketamine, propofol&#xD;
ketamine, propofol: anesthesia with ketofol in pediatric surgery</description>
        </group>
        <group group_id="B2">
          <title>Pediatric Anesthesia With Ketofol Plus Lidocaine</title>
          <description>ketamine, propofol, lidocaine&#xD;
ketamine, propofol, lidocaine: anesthesia with ketofol plus lidocaine in pediatric surgery</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="100"/>
            <count group_id="B2" value="100"/>
            <count group_id="B3" value="200"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age 1-12 years old, male and female, for short pediatric surgery (max 60 min.)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="200"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 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>&gt;=65 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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </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>Croatia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>sevoflurane for iv cannula</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children</title>
        <time_frame>up to 600 seconds</time_frame>
        <population>age 1-12, male and female, pediatric short surgery</population>
        <group_list>
          <group group_id="O1">
            <title>Pediatric Anesthesia With Ketofol</title>
            <description>ketamine, propofol&#xD;
ketamine, propofol: anesthesia with ketofol in pediatric surgery</description>
          </group>
          <group group_id="O2">
            <title>Pediatric Anesthesia With Ketofol Plus Lidocaine</title>
            <description>ketamine, propofol, lidocaine&#xD;
ketamine, propofol, lidocaine: anesthesia with ketofol plus lidocaine in pediatric surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children</title>
          <population>age 1-12, male and female, pediatric short surgery</population>
          <units>second</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="240" lower_limit="120" upper_limit="340"/>
                    <measurement group_id="O2" value="120" lower_limit="41.5" upper_limit="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Length of Stay in the PACU</title>
        <time_frame>up to 40 minutes</time_frame>
        <population>Age 1-12 years, male and female, pediatric short surgery</population>
        <group_list>
          <group group_id="O1">
            <title>Pediatric Anesthesia With Ketofol</title>
            <description>ketamine, propofol&#xD;
ketamine, propofol: anesthesia with ketofol in pediatric surgery</description>
          </group>
          <group group_id="O2">
            <title>Pediatric Anesthesia With Ketofol Plus Lidocaine</title>
            <description>ketamine, propofol, lidocaine&#xD;
ketamine, propofol, lidocaine: anesthesia with ketofol plus lidocaine in pediatric surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Length of Stay in the PACU</title>
          <population>Age 1-12 years, male and female, pediatric short surgery</population>
          <units>minute</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35" lower_limit="30" upper_limit="40"/>
                    <measurement group_id="O2" value="20" lower_limit="20" upper_limit="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption</title>
        <time_frame>up to 60 minutes</time_frame>
        <population>Age 1-12 years, male and female, pediatric short surgery</population>
        <group_list>
          <group group_id="O1">
            <title>Pediatric Anesthesia With Ketofol</title>
            <description>ketamine, propofol&#xD;
ketamine, propofol: anesthesia with ketofol in pediatric surgery</description>
          </group>
          <group group_id="O2">
            <title>Pediatric Anesthesia With Ketofol Plus Lidocaine</title>
            <description>ketamine, propofol, lidocaine&#xD;
ketamine, propofol, lidocaine: anesthesia with ketofol plus lidocaine in pediatric surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption</title>
          <population>Age 1-12 years, male and female, pediatric short surgery</population>
          <units>microgram per kg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="2" upper_limit="3"/>
                    <measurement group_id="O2" value="2.1" lower_limit="2" upper_limit="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 months</time_frame>
      <desc>NO adverse event.</desc>
      <group_list>
        <group group_id="E1">
          <title>Pediatric Anesthesia With Ketofol</title>
          <description>ketamine, propofol&#xD;
ketamine, propofol: anesthesia with ketofol in pediatric surgery</description>
        </group>
        <group group_id="E2">
          <title>Pediatric Anesthesia With Ketofol Plus Lidocaine</title>
          <description>ketamine, propofol, lidocaine&#xD;
ketamine, propofol, lidocaine: anesthesia with ketofol plus lidocaine in pediatric surgery</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </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="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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. Ana Nevescanin Biliskov, pediatric anesthesiologist</name_or_title>
      <organization>University Hospital of Split</organization>
      <phone>00385912508001</phone>
      <email>anevescanin@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/NCT04467424
org study id: Ketofol-Lidocaine
nct id: NCT04467424
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Two hundred children aged 1-12 years undergoing short surgery will be randomized into two
      groups. Ketofol will be used for induction and maintenance of anesthesia in group l. .Ketofol
      with lidocaine will be prepared for group ll. A reducted McFarlan infusion dose will be used.
      Extubating time, duration of anesthesia, length of stay in post-anesthesia care unit (PACU)
      will be recorded.
Aim of the research: In this study investigators want to examine the effectiveness of the use
      of ketofol and a mixture of ketofol and lidocaine on the total consumption of opioids and on
      the postoperative recovery of pediatric patients. Investigators will evaluate the safety,
      efficacy, and outcomes of the anesthesia procedure with respect to the administration of
      different anesthetics, specific pharmakocinetic profiles and compare the length of recovery
      between patients in two groups.

      Including criteria: children aged 1 to 12 years who underwent short surgery (up to 60 min).

      Primary and secondary outcome measures: The primary outcome of this study will be extubation
      time and the secondary outcome will be time spend in PACU.

      Description of the study: Each subject included in the study will be given general anesthesia
      with ketofol or ketofol and lidocaine, with the addition of fentanyl. After 20 s the LMA will
      be placed. Maintenance of anesthesia will be performed using an air / oxygen mixture (50% /
      50%) and an infusion of ketofol or ketofol and lidocaine. Ketofol will be prepare in a ratio
      of 1: 4 for induction and 1: 7 for maintenance. The same mixtures of ketofol will be added 1
      ml of 2% lidocaine for the second group of patients. After extubation, patients will be
      transferred to the PACU.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children
time frame: up to 600 seconds
measure: Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Length of Stay in the PACU
time frame: up to 40 minutes
measure: Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption
time frame: up to 60 minutes
arm group label: Pediatric anesthesia with ketofol
arm group type: Experimental
description: ketamine, propofol
arm group label: Pediatric anesthesia with ketofol plus lidocaine
arm group type: Experimental
description: ketamine, propofol, lidocaine
intervention type: Drug
intervention name: ketamine, propofol
description: anesthesia with ketofol in pediatric surgery
arm group label: Pediatric anesthesia with ketofol
intervention type: Drug
intervention name: ketamine, propofol, lidocaine
description: anesthesia with ketofol plus lidocaine in pediatric surgery
arm group label: Pediatric anesthesia with ketofol plus lidocaine
criteria: 
gender: All
minimum age: 1 Year
maximum age: 12 Years
healthy volunteers: No
facility: 
country: Croatia
responsible party type: Principal Investigator
investigator affiliation: University Hospital of Split
investigator full name: Ana N Biliškov, MD
investigator title: Pediatric anesthesiologist
mesh term: Lidocaine
mesh term: Ketamine
mesh term: Propofol
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 