<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/NCT03290859</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201701064 - N</org_study_id>
    <secondary_id>UL1TR001427</secondary_id>
    <secondary_id>OCR18882</secondary_id>
    <nct_id>NCT03290859</nct_id>
  </id_info>
  <brief_title>Race-Specific Propofol Titration to Effect for Procedural Sedation</brief_title>
  <official_title>Pragmatic Clinical Trial of Race-Specific Response to Propofol Infusion Titrated to Effect for Procedural Sedation During Endoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Advancing Translational Sciences (NCATS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospectively evaluate newly established guidelines and make clinicians aware of inter-racial&#xD;
      difference in propofol sensitivity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary motivation in conducting this study is to conduct the implementation science,&#xD;
      i.e., formalize and train, and retrain if needed, anesthesia providers in the standard&#xD;
      practice of titrating infusion rate to effect and clinically evaluate the effect of race and&#xD;
      ethnicity on propofol monotherapy sedation during GI endoscopy. The ultimate goal is to make&#xD;
      it less likely that patients from races known to be sensitive to propofol experience&#xD;
      inadvertent overdosing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2018</start_date>
  <completion_date type="Actual">February 5, 2019</completion_date>
  <primary_completion_date type="Actual">February 5, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the recovery times among races and ethnicities</measure>
    <time_frame>Change from baseline up to 24 hours</time_frame>
    <description>Monitored using aggregate data for metrics of recovery times</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2780</enrollment>
  <condition>Unconsciousness</condition>
  <condition>Apnea, Postanesthetic</condition>
  <condition>Sedative Overdose</condition>
  <condition>Hypoxemia</condition>
  <arm_group>
    <arm_group_label>Training intervention</arm_group_label>
    <description>Train anesthesia providers who deliver propofol sedation for GI endoscopy procedures to follow a uniform propofol monotherapy administration guideline to titrate propofol monotherapy infusion to effect according to a standardized protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Effectiveness of training intervention</arm_group_label>
    <description>Compare the effectiveness of training intervention and standardized titration to effect through aggregate data for metrics of recovery times.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Titrate propofol monotherapy infusion to effect</intervention_name>
    <description>Train anesthesia providers in a standardized protocol for titrating propofol infusion to effect.</description>
    <arm_group_label>Training intervention</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Compare in buccal samples the frequency of cytochrome allele carrier status in patients&#xD;
      exhibiting sensitivity to propofol during the procedural time against published frequency&#xD;
      data in Single Nucleotide Polymorphism database (dbSNP) by race.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing propofol sedation at Gainesville (GNV) and Jacksonville (JAX) GI&#xD;
        Endoscopy suites&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing propofol sedation at Gainesville (GNV) and Jacksonville (JAX) GI&#xD;
             Endoscopy suites&#xD;
&#xD;
          -  Age range 18 - 80 years old&#xD;
&#xD;
          -  Patients whose race can be identified from the electronic patient information chart&#xD;
             (EPIC)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who identify as multiracial in Epic&#xD;
&#xD;
          -  Patients who identify as Other in Epic&#xD;
&#xD;
          -  Patients who refuse to indicate their race in Epic&#xD;
&#xD;
          -  Patients whose race is listed as unknown in Epic&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey White, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UF Health</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>October 23, 2019</last_update_submitted>
  <last_update_submitted_qc>October 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Procedural Sedation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Unconsciousness</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03290859
org study id: IRB201701064 - N
secondary id: UL1TR001427
secondary id: OCR18882
nct id: NCT03290859
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Prospectively evaluate newly established guidelines and make clinicians aware of inter-racial
      difference in propofol sensitivity.
The primary motivation in conducting this study is to conduct the implementation science,
      i.e., formalize and train, and retrain if needed, anesthesia providers in the standard
      practice of titrating infusion rate to effect and clinically evaluate the effect of race and
      ethnicity on propofol monotherapy sedation during GI endoscopy. The ultimate goal is to make
      it less likely that patients from races known to be sensitive to propofol experience
      inadvertent overdosing.
observational model: Case-Control
time perspective: Prospective
measure: Change in the recovery times among races and ethnicities
time frame: Change from baseline up to 24 hours
description: Monitored using aggregate data for metrics of recovery times
arm group label: Training intervention
description: Train anesthesia providers who deliver propofol sedation for GI endoscopy procedures to follow a uniform propofol monotherapy administration guideline to titrate propofol monotherapy infusion to effect according to a standardized protocol.
arm group label: Effectiveness of training intervention
description: Compare the effectiveness of training intervention and standardized titration to effect through aggregate data for metrics of recovery times.
intervention type: Procedure
intervention name: Titrate propofol monotherapy infusion to effect
description: Train anesthesia providers in a standardized protocol for titrating propofol infusion to effect.
arm group label: Training intervention
Compare in buccal samples the frequency of cytochrome allele carrier status in patients
      exhibiting sensitivity to propofol during the procedural time against published frequency
      data in Single Nucleotide Polymorphism database (dbSNP) by race.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jeffrey White, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Unconsciousness
mesh term: Hypoxia
mesh term: Propofol
sharing ipd: No