<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/NCT02982928</url>
  </required_header>
  <id_info>
    <org_study_id>IRB15-00471</org_study_id>
    <nct_id>NCT02982928</nct_id>
  </id_info>
  <brief_title>Tylenol Levels in Bariatric Patients</brief_title>
  <official_title>Acetaminophen Pharmacokinetics in Bariatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nationwide Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current study is designed to measure and evaluate the pharmacokinetic profiling of&#xD;
      acetaminophen in the young obese patient population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a descriptive study carried out by study staff from the anesthesiology&#xD;
      department. The patient population will include obese patients scheduled for robot-assisted&#xD;
      or laparoscopic bariatric surgery. There will be no change in our usual anesthetic care for&#xD;
      these patients. Volume of distribution and elimination half-life of acetaminophen in serum&#xD;
      samples are the primary measurements of the study. If detected, a significant reduction in&#xD;
      opioid requirements may lead to improved patient satisfaction and decreased opiate side&#xD;
      effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2017</start_date>
  <completion_date type="Actual">January 22, 2018</completion_date>
  <primary_completion_date type="Actual">January 22, 2018</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>Intra- and Post-operative Serum Concentrations</measure>
    <time_frame>15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; 8 Hours; and 12-Hours Post-IV acetaminophen administration</time_frame>
    <description>To determine whether adequate serum concentration of acetaminophen is achieved.</description>
  </primary_outcome>
  <enrollment type="Actual">11</enrollment>
  <condition>Obesity</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum Samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will consist of 30 patients presenting to the OR for robotic assisted&#xD;
        or laparoscopic bariatric surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 12, but younger than 21 years of age undergoing robotic assisted&#xD;
             or laparoscopic bariatric surgery&#xD;
&#xD;
          -  American Society of Anesthesiologists Physical Status Classification System (ASA) I,&#xD;
             II or III&#xD;
&#xD;
          -  Parent/guardian willing and able to give consent&#xD;
&#xD;
          -  Patient willing to give assent, or consent&#xD;
&#xD;
          -  Patients that are otherwise healthy at the discretion of the study staff&#xD;
&#xD;
          -  Patients with BMI &gt;95th percentile&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe right heart failure or severe asthma&#xD;
&#xD;
          -  Patients with deficient hepatic function that can affect drug metabolism&#xD;
&#xD;
          -  Systemic steroid use within the last 3 months&#xD;
&#xD;
          -  Patients who have taken acetaminophen containing medications within 24 hours of&#xD;
             surgery date&#xD;
&#xD;
          -  Patients younger than 12, but older than 21 years of age undergoing robotic assisted&#xD;
             or laparoscopic bariatric surgery&#xD;
&#xD;
          -  Patients having other procedures in addition to robotic assisted or laparoscopic&#xD;
             bariatric surgery&#xD;
&#xD;
          -  American Society of Anesthesiologists Physical Status Classification System (ASA) IV&#xD;
             and above&#xD;
&#xD;
          -  Females testing positive for pregnancy&#xD;
&#xD;
          -  Parent/guardian not willing and able to give assent, or consent&#xD;
&#xD;
          -  Patient not willing to give assent, or consent&#xD;
&#xD;
          -  Patients with BMI &lt; 95th percentile&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahsan Syed, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nationwide Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ziemann-Gimmel P, Hensel P, Koppman J, Marema R. Multimodal analgesia reduces narcotic requirements and antiemetic rescue medication in laparoscopic Roux-en-Y gastric bypass surgery. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):975-80. doi: 10.1016/j.soard.2013.02.003. Epub 2013 Feb 13.</citation>
    <PMID>23499469</PMID>
  </reference>
  <reference>
    <citation>Saurabh S, Smith JK, Pedersen M, Jose P, Nau P, Samuel I. Scheduled intravenous acetaminophen reduces postoperative narcotic analgesic demand and requirement after laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2015 Mar-Apr;11(2):424-30. doi: 10.1016/j.soard.2014.09.017. Epub 2014 Sep 30.</citation>
    <PMID>25614351</PMID>
  </reference>
  <reference>
    <citation>Abernethy DR, Divoll M, Greenblatt DJ, Ameer B. Obesity, sex, and acetaminophen disposition. Clin Pharmacol Ther. 1982 Jun;31(6):783-90. doi: 10.1038/clpt.1982.111.</citation>
    <PMID>7075126</PMID>
  </reference>
  <reference>
    <citation>Lee WH, Kramer WG, Granville GE. The effect of obesity on acetaminophen pharmacokinetics in man. J Clin Pharmacol. 1981 Jul;21(7):284-7. doi: 10.1002/j.1552-4604.1981.tb01768.x.</citation>
    <PMID>7263926</PMID>
  </reference>
  <reference>
    <citation>Birmingham PK, Tobin MJ, Henthorn TK, Fisher DM, Berkelhamer MC, Smith FA, Fanta KB, Cote CJ. Twenty-four-hour pharmacokinetics of rectal acetaminophen in children: an old drug with new recommendations. Anesthesiology. 1997 Aug;87(2):244-52. doi: 10.1097/00000542-199708000-00010.</citation>
    <PMID>9286887</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <results_first_submitted>December 10, 2018</results_first_submitted>
  <results_first_submitted_qc>March 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 19, 2019</results_first_posted>
  <last_update_submitted>March 20, 2019</last_update_submitted>
  <last_update_submitted_qc>March 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Ahsan Syed</investigator_full_name>
    <investigator_title>Attending Anesthesiologist</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Bariatrics</keyword>
  <keyword>Acetaminophen</keyword>
  <keyword>robot-assisted or laparoscopic bariatric surgery</keyword>
  <keyword>Pharmacokinetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT02982928/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bariatric Surgery</title>
          <description>Obese pediatric and young adult patients undergoing robotic or laparoscopic bariatric surgery (vertical sleeve gastrectomy).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </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>
      <group_list>
        <group group_id="B1">
          <title>Bariatric Surgery</title>
          <description>Obese pediatric and young adult patients undergoing robotic or laparoscopic bariatric surgery (vertical sleeve gastrectomy).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
          </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="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="17" spread="2"/>
                  </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_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>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI (kg/m2)</title>
          <units>Kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Intra- and Post-operative Serum Concentrations</title>
        <description>To determine whether adequate serum concentration of acetaminophen is achieved.</description>
        <time_frame>15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; 8 Hours; and 12-Hours Post-IV acetaminophen administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bariatric Surgery</title>
            <description>Obese pediatric and young adult patients undergoing robotic or laparoscopic bariatric surgery (vertical sleeve gastrectomy).</description>
          </group>
        </group_list>
        <measure>
          <title>Intra- and Post-operative Serum Concentrations</title>
          <description>To determine whether adequate serum concentration of acetaminophen is achieved.</description>
          <units>µg.mL-1</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15-20 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30-40 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" spread="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50-70 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>80-100 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bariatric Surgery</title>
          <description>Obese pediatric and young adult patients undergoing robotic or laparoscopic bariatric surgery (vertical sleeve gastrectomy).</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="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
              </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="11"/>
              </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>Ahsan Syed, MD</name_or_title>
      <organization>Nationwide Children's Hospital</organization>
      <phone>614-722-4200</phone>
      <email>Ahsan.Syed@nationwidechildrens.org</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/NCT02982928
org study id: IRB15-00471
nct id: NCT02982928
lead sponsor: 
has dmc: No
The current study is designed to measure and evaluate the pharmacokinetic profiling of
      acetaminophen in the young obese patient population.
This will be a descriptive study carried out by study staff from the anesthesiology
      department. The patient population will include obese patients scheduled for robot-assisted
      or laparoscopic bariatric surgery. There will be no change in our usual anesthetic care for
      these patients. Volume of distribution and elimination half-life of acetaminophen in serum
      samples are the primary measurements of the study. If detected, a significant reduction in
      opioid requirements may lead to improved patient satisfaction and decreased opiate side
      effects.
observational model: Cohort
time perspective: Prospective
measure: Intra- and Post-operative Serum Concentrations
time frame: 15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; 8 Hours; and 12-Hours Post-IV acetaminophen administration
description: To determine whether adequate serum concentration of acetaminophen is achieved.
Serum Samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 21 Years
healthy volunteers: No
last name: Ahsan Syed, MD
role: Principal Investigator
affiliation: Nationwide Children's Hospital
facility: 
country: United States
citation: Ziemann-Gimmel P, Hensel P, Koppman J, Marema R. Multimodal analgesia reduces narcotic requirements and antiemetic rescue medication in laparoscopic Roux-en-Y gastric bypass surgery. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):975-80. doi: 10.1016/j.soard.2013.02.003. Epub 2013 Feb 13.
PMID: 23499469
citation: Saurabh S, Smith JK, Pedersen M, Jose P, Nau P, Samuel I. Scheduled intravenous acetaminophen reduces postoperative narcotic analgesic demand and requirement after laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2015 Mar-Apr;11(2):424-30. doi: 10.1016/j.soard.2014.09.017. Epub 2014 Sep 30.
PMID: 25614351
citation: Abernethy DR, Divoll M, Greenblatt DJ, Ameer B. Obesity, sex, and acetaminophen disposition. Clin Pharmacol Ther. 1982 Jun;31(6):783-90. doi: 10.1038/clpt.1982.111.
PMID: 7075126
citation: Lee WH, Kramer WG, Granville GE. The effect of obesity on acetaminophen pharmacokinetics in man. J Clin Pharmacol. 1981 Jul;21(7):284-7. doi: 10.1002/j.1552-4604.1981.tb01768.x.
PMID: 7263926
citation: Birmingham PK, Tobin MJ, Henthorn TK, Fisher DM, Berkelhamer MC, Smith FA, Fanta KB, Cote CJ. Twenty-four-hour pharmacokinetics of rectal acetaminophen in children: an old drug with new recommendations. Anesthesiology. 1997 Aug;87(2):244-52. doi: 10.1097/00000542-199708000-00010.
PMID: 9286887
responsible party type: Principal Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Ahsan Syed
investigator title: Attending Anesthesiologist
mesh term: Obesity
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 