<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/NCT02200744</url>
  </required_header>
  <id_info>
    <org_study_id>2013/CHU/08</org_study_id>
    <secondary_id>2013-003669-32</secondary_id>
    <nct_id>NCT02200744</nct_id>
  </id_info>
  <brief_title>Incidence of Recall After Procedural Sedation With Propofol in the Emergency Department</brief_title>
  <acronym>MEMOPROPO</acronym>
  <official_title>Incidence of Recall After Procedural Sedation With Propofol in the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de la Réunion</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de la Réunion</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the incidence of recall in patients managed in&#xD;
      emergency department with a procedural sedation protocol using propofol in a population of&#xD;
      250 .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After procedural sedation for fracture or joint dislocation reduction using propofol, adult&#xD;
      patients recall will be assessed with a standardised form. This recall assessment will be&#xD;
      realised 2 hours (+/- 15 minutes) after the procedural sedation and the day after.&#xD;
&#xD;
      The primary outcome measure will be the recall incidence 2 hours (+/- 15 minutes) after a&#xD;
      procedural sedation. A secondary outcome will be the recall incidence one day after the&#xD;
      procedural sedation.&#xD;
&#xD;
      The recall will be defined by a positive answer to the third question of the Sandin form&#xD;
      (Lancet. 2000;355(9205):707-11).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2014</start_date>
  <completion_date type="Anticipated">April 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2016</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>Recall incidence</measure>
    <time_frame>At 2 hours (+/- 15 minutes) after procedural sedation with propofol</time_frame>
    <description>questionnaire of Brice amended by Sandin</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recall incidence</measure>
    <time_frame>About 24 hours after procedural sedation with propofol</time_frame>
    <description>The patient will be contacted by phone the next day after procedural sedation with propofol. They will answer the questionnaire of Brice amended by Sandin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's satisfaction assessment</measure>
    <time_frame>At 2 hours (+/- 15 minutes) after procedural sedation with propofol</time_frame>
    <description>numerical verbal scale</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Fractures Reduction</condition>
  <condition>Joint Dislocation Reduction</condition>
  <arm_group>
    <arm_group_label>Dislocation reduction using propofol</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults patients managed in emergency department with a procedural sedation protocol using&#xD;
        propofol&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults patients (&gt; 18 years old) who had a procedural sedation in emergency department&#xD;
             using propofol for fracture or joint dislocation reduction&#xD;
&#xD;
          -  Patients who received an initial injection of Propofol by slow intravenous injection&#xD;
             of 1 mg/kg in 20 seconds&#xD;
&#xD;
          -  Inclusion less than 2 hours from the injection of Propofol&#xD;
&#xD;
          -  Patients who have signed a consent to participate in the study&#xD;
&#xD;
          -  Patients covered by social security.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years old&#xD;
&#xD;
          -  Patients who cannot signed the informed consent&#xD;
&#xD;
          -  Patients who had procedural sedation using other drugs that propofol&#xD;
&#xD;
          -  Participation in another study type biomedical research&#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>Pierre-Jean Marianne, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de La Réunion</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marc Weber, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Groupe Hospitalier Est Réunion</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katia Mougin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Gabriel Martin</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xavier Combes, MD</last_name>
    <phone>02 62 90 60 70</phone>
    <email>x.combes.samu974@chu-reunion.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Groupe Hospitalier Est Réunion</name>
      <address>
        <city>Saint Benoît</city>
        <state>La Réunion</state>
        <zip>97470</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marc Weber, MD</last_name>
    </contact>
    <investigator>
      <last_name>Marc Weber, Md</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de la Réunion</name>
      <address>
        <city>Saint Denis</city>
        <state>La Réunion</state>
        <zip>97400</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xavier Combes, MD</last_name>
      <phone>02 62 90 60 70</phone>
      <email>x.combes.samu974@chu-reunion.fr</email>
    </contact>
    <investigator>
      <last_name>Xavier Combes, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Gabriel Martin</name>
      <address>
        <city>Saint Paul</city>
        <state>La Réunion</state>
        <zip>97460</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ophelie Pierotti, MD</last_name>
      <phone>0692702330</phone>
      <email>opierotti222@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Ophelie Pierotti, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de La Réunion</name>
      <address>
        <city>Saint Pierre</city>
        <state>La Réunion</state>
        <zip>97448</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pierre-Jean Marianne, MD</last_name>
      <phone>02 62 71 98 57</phone>
      <email>pierre-jean.marianne-cassou@chu-reunion.fr</email>
    </contact>
    <investigator>
      <last_name>Pierre-Jean Marianne, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>February 3, 2015</last_update_submitted>
  <last_update_submitted_qc>February 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Procedural sedation</keyword>
  <keyword>emergency department</keyword>
  <keyword>adults</keyword>
  <keyword>propofol</keyword>
  <keyword>recall assessment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Dislocations</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <!-- 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/NCT02200744
org study id: 2013/CHU/08
secondary id: 2013-003669-32
nct id: NCT02200744
lead sponsor: 
has dmc: No
The purpose of this study is to determine the incidence of recall in patients managed in
      emergency department with a procedural sedation protocol using propofol in a population of
      250 .
After procedural sedation for fracture or joint dislocation reduction using propofol, adult
      patients recall will be assessed with a standardised form. This recall assessment will be
      realised 2 hours (+/- 15 minutes) after the procedural sedation and the day after.

      The primary outcome measure will be the recall incidence 2 hours (+/- 15 minutes) after a
      procedural sedation. A secondary outcome will be the recall incidence one day after the
      procedural sedation.

      The recall will be defined by a positive answer to the third question of the Sandin form
      (Lancet. 2000;355(9205):707-11).
observational model: Cohort
time perspective: Prospective
measure: Recall incidence
time frame: At 2 hours (+/- 15 minutes) after procedural sedation with propofol
description: questionnaire of Brice amended by Sandin
measure: Recall incidence
time frame: About 24 hours after procedural sedation with propofol
description: The patient will be contacted by phone the next day after procedural sedation with propofol. They will answer the questionnaire of Brice amended by Sandin
measure: Patient's satisfaction assessment
time frame: At 2 hours (+/- 15 minutes) after procedural sedation with propofol
description: numerical verbal scale
arm group label: Dislocation reduction using propofol
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre-Jean Marianne, MD
role: Principal Investigator
affiliation: CHU de La Réunion
last name: Marc Weber, MD
role: Principal Investigator
affiliation: Groupe Hospitalier Est Réunion
last name: Katia Mougin, MD
role: Principal Investigator
affiliation: Centre Hospitalier Gabriel Martin
last name: Xavier Combes, MD
phone: 02 62 90 60 70
email: x.combes.samu974@chu-reunion.fr
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Joint Dislocations
mesh term: Emergencies