<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/NCT03783494</url>
  </required_header>
  <id_info>
    <org_study_id>18-PP-04</org_study_id>
    <nct_id>NCT03783494</nct_id>
  </id_info>
  <brief_title>Target-controlled Infusion With Propofol in the Emergency Department : a Prospective Study on 45 Adult Patients</brief_title>
  <acronym>SIVOC</acronym>
  <official_title>Target-controlled Infusion With Propofol in the Emergency Department : a Prospective Study on 45 Adult Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</source>
  <oversight_info>
    <has_dmc>No</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>
      Procedural sedation is an emergency medicine technique that provides a brief, deep sedation&#xD;
      in order to perform very painful emergency emergent procedures such as displaced fracture or&#xD;
      dislocated joints reduction. Propofol is recommended for this purpose, injected administered&#xD;
      in slow IV bolus injections according to the technique known as manual titration. But despite&#xD;
      this precaution, temporarily excessive sedation can happen, and a side effect can appear&#xD;
      (arterial hypotension or respiratory depression). Target-controlled infusion (TCI) is an&#xD;
      anesthesia technique that permits to obtain a precise constant and stable concentration of&#xD;
      medication, boluses volumes of injection being calculated and delivered automatically by an&#xD;
      electric syringe equipped with a software obedient to existing pharmacokinetic models. In the&#xD;
      operating room, Ffor anesthetic induction, maintenance and awakening, respectively, in the&#xD;
      operating room, the brain concentrations of propofol range respectively from 2 to 6 μg/mL, 2&#xD;
      to 4 μg/mL, and between 0.8 and 1.2 μg/mL, respectively. Since TCI has never been used in&#xD;
      emergency departments (ED), the brain propofol concentrations which are necessary for&#xD;
      sedation and awakening of the patient are not known and must be determined experimentally.&#xD;
&#xD;
      In this single-center, prospective, interventional study, safety and feasibility of TCI will&#xD;
      be studied in one ED with the primary objective of determining the brain propofol&#xD;
      concentrations necessary to reach the an optimal sedation in for patients with indications of&#xD;
      sustaining very painful orthopedic emergency emergent procedures&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Procedural sedation is an emergency medicine technique that provides a brief, deep sedation&#xD;
      in order to perform very painful emergency emergent procedures such as displaced fracture or&#xD;
      dislocated joints reduction. For this purpose, propofol is a remarkable sedative agent for&#xD;
      its very short elimination half-life, antiemetic property and myorelaxant effects. It is&#xD;
      recommended to inject administer it in slow IV boluses injections according to the technique&#xD;
      known as manual titration, but despite this precaution, temporarily excessive sedation can&#xD;
      happen, and a side effect appear (arterial hypotension or respiratory depression).&#xD;
&#xD;
      Target-controlled infusion (TCI) is an anesthesia technique that permits to obtain a precise&#xD;
      constant and stable concentration of medication, boluses volumes of injection being&#xD;
      calculated and delivered automatically by an electric syringe equipped with a software&#xD;
      obedient to existing pharmacokinetic models.&#xD;
&#xD;
      The age, size and weight of the patient are filledentered, then the syringe delivers the&#xD;
      volume which is necessary and sufficient to reach and maintain the target concentration&#xD;
      chosen by the practitioner. For anesthetic induction in the operating room, the brain&#xD;
      concentrations of propofol used range from 2 to 6 μg/mL, then the general anesthesia&#xD;
      maintenance is obtained with 2 to 4 μg/mL, and the patient awakening usually happens between&#xD;
      0.8 and 1.2 μg/mL. Since TCI has never been used in emergency departments (ED), the brain&#xD;
      propofol concentrations which are necessary for sedation and awakening of the patient are not&#xD;
      known and must be determined experimentally.&#xD;
&#xD;
      In this single-center, prospective, interventional study, safety and feasibility of TCI will&#xD;
      be studied in an ED with the primary objective of determining the brain propofol&#xD;
      concentrations necessary to reach the an optimal sedation in for patients with indications&#xD;
      ofsustaining very painful orthopedic emergency emergent procedures. As secondary objectives,&#xD;
      we will study the characteristics of sedations obtained (level, delays, lengths); the Delays,&#xD;
      lengths and levels of sedation obtained, overall delivered doses of propofol administered;&#xD;
      the , nature, appearance delays and lengths of potential adverse events (AE) related to&#xD;
      procedural sedation, particularly complications related to procedural sedation, and necessary&#xD;
      interventions necessary to handle these AE., will be studied as secondary objectives&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 10, 2019</start_date>
  <completion_date type="Anticipated">April 10, 2020</completion_date>
  <primary_completion_date type="Actual">April 10, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Propofol brain concentration</measure>
    <time_frame>Between the beginning of sedation (T0) and the beginning of the orthopedic procedure (T_Ramsay5)</time_frame>
    <description>Propofol brain concentration necessary for the patient to reach a Ramsay score of 5 (optimal sedation) (Ce_Ramsay5)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delay between the beginning of sedation (T0) and the beginning of the orthopedic procedure (T_Ramsay5)</measure>
    <time_frame>the delay is the outcome, T_Ramsay5 (up to an anticipated average maximal time of 15 minutes after T0)]</time_frame>
    <description>the delay is the outcome, T_Ramsay5 (up to an anticipated average maximal time of 15 minutes after T0)]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Propofol brain concentration when the patient spontaneously reopen his eyes (Ce_OuvertureYeux)</measure>
    <time_frame>Time after T0 when the patient spontaneously reopen his eyes (up to an anticipated average maximal time of 30 minutes after T0)</time_frame>
    <description>Propofol brain concentration when the patient spontaneously reopen his eyes after the orthopedic procedure has been realized, the TCI syringe been switched off, and the immobilization been placed (Ce_OuvertureYeux)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Joint Dislocation</condition>
  <condition>Limb Fracture</condition>
  <arm_group>
    <arm_group_label>Target-controlled infusion (TCI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Target-controlled infusion (TCI) with propofol up to 5.5µg/ml during an anticipated average maximal time of 15 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Target control infusion with propofol</intervention_name>
    <description>Target control infusion with propofol for patients with indications of sustaining very painful orthopedic emergency emergent procedures</description>
    <arm_group_label>Target-controlled infusion (TCI)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of 18 or more&#xD;
&#xD;
          -  Affiliated or beneficiary of a French health insurance system&#xD;
&#xD;
          -  Indication of procedural sedation, by the emergency department physician in the&#xD;
             context of the management of for a patient with an orthopedic lesion requiring a&#xD;
             potentially painful emergentcy therapeutic actionprocedure (reduction of a joint&#xD;
             dislocation or realignment of a limb displaced fracture)&#xD;
&#xD;
          -  For women :&#xD;
&#xD;
               -  at childbearing age : effective contraception (oral, intra-uterine device or&#xD;
                  condoms)&#xD;
&#xD;
               -  postmenopausal : amenorrhea for at least 12 month before the inclusion day&#xD;
&#xD;
               -  objective infertility (diagnosis or surgically)&#xD;
&#xD;
          -  Signed free informed consent or inclusion in the context of an emergency situation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient of more than 18 under legal protection or deprivation of liberty measures&#xD;
&#xD;
          -  Ongoing pregnancy or breastfeeding women&#xD;
&#xD;
          -  Patient with the incapacity to give his free informed consent, excepted if the&#xD;
             incapacity is induced by the context of the emergency situation (inclusion in the&#xD;
             context of an emergency situation)&#xD;
&#xD;
          -  Known hypersensitivity to propofol or one of the excipients, egg, sojasoya or peanuts&#xD;
&#xD;
          -  ASA comorbidity score of 4 or more&#xD;
&#xD;
          -  Heart, respiratory, renal or hepatic failure&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Lipid metabolism disorder&#xD;
&#xD;
          -  Mitochondrial disease&#xD;
&#xD;
          -  Hemodynamic instability, multiple traumatism&#xD;
&#xD;
          -  Elevated intracranial tension&#xD;
&#xD;
          -  Drug or alcohol intoxication&#xD;
&#xD;
          -  Simultaneous participation to another interventional study&#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>Fabien LEMOEL, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emergency Department, Universitary Hospital of Nice</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fabien LEMOEL, PhD</last_name>
    <phone>0492038535</phone>
    <phone_ext>0033</phone_ext>
    <email>lemoel.f@chu-nice.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jocelyn RAPP</last_name>
    <phone>0492038535</phone>
    <phone_ext>0033</phone_ext>
    <email>rapp.j@chu-nice.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Emergency Department</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Delphine DEL CONT, PM</last_name>
      <email>delcont.d@chu-nice.fr</email>
    </contact>
    <investigator>
      <last_name>Fabien LEMOEL, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>April 30, 2019</last_update_submitted>
  <last_update_submitted_qc>April 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ED</keyword>
  <keyword>dislocation reduction</keyword>
  <keyword>emergency department</keyword>
  <keyword>TCI</keyword>
  <keyword>Target-controlled infusion</keyword>
  <keyword>sedation</keyword>
  <keyword>fracture reduction</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>
  <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/NCT03783494
org study id: 18-PP-04
nct id: NCT03783494
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Procedural sedation is an emergency medicine technique that provides a brief, deep sedation
      in order to perform very painful emergency emergent procedures such as displaced fracture or
      dislocated joints reduction. Propofol is recommended for this purpose, injected administered
      in slow IV bolus injections according to the technique known as manual titration. But despite
      this precaution, temporarily excessive sedation can happen, and a side effect can appear
      (arterial hypotension or respiratory depression). Target-controlled infusion (TCI) is an
      anesthesia technique that permits to obtain a precise constant and stable concentration of
      medication, boluses volumes of injection being calculated and delivered automatically by an
      electric syringe equipped with a software obedient to existing pharmacokinetic models. In the
      operating room, Ffor anesthetic induction, maintenance and awakening, respectively, in the
      operating room, the brain concentrations of propofol range respectively from 2 to 6 μg/mL, 2
      to 4 μg/mL, and between 0.8 and 1.2 μg/mL, respectively. Since TCI has never been used in
      emergency departments (ED), the brain propofol concentrations which are necessary for
      sedation and awakening of the patient are not known and must be determined experimentally.

      In this single-center, prospective, interventional study, safety and feasibility of TCI will
      be studied in one ED with the primary objective of determining the brain propofol
      concentrations necessary to reach the an optimal sedation in for patients with indications of
      sustaining very painful orthopedic emergency emergent procedures
Procedural sedation is an emergency medicine technique that provides a brief, deep sedation
      in order to perform very painful emergency emergent procedures such as displaced fracture or
      dislocated joints reduction. For this purpose, propofol is a remarkable sedative agent for
      its very short elimination half-life, antiemetic property and myorelaxant effects. It is
      recommended to inject administer it in slow IV boluses injections according to the technique
      known as manual titration, but despite this precaution, temporarily excessive sedation can
      happen, and a side effect appear (arterial hypotension or respiratory depression).

      Target-controlled infusion (TCI) is an anesthesia technique that permits to obtain a precise
      constant and stable concentration of medication, boluses volumes of injection being
      calculated and delivered automatically by an electric syringe equipped with a software
      obedient to existing pharmacokinetic models.

      The age, size and weight of the patient are filledentered, then the syringe delivers the
      volume which is necessary and sufficient to reach and maintain the target concentration
      chosen by the practitioner. For anesthetic induction in the operating room, the brain
      concentrations of propofol used range from 2 to 6 μg/mL, then the general anesthesia
      maintenance is obtained with 2 to 4 μg/mL, and the patient awakening usually happens between
      0.8 and 1.2 μg/mL. Since TCI has never been used in emergency departments (ED), the brain
      propofol concentrations which are necessary for sedation and awakening of the patient are not
      known and must be determined experimentally.

      In this single-center, prospective, interventional study, safety and feasibility of TCI will
      be studied in an ED with the primary objective of determining the brain propofol
      concentrations necessary to reach the an optimal sedation in for patients with indications
      ofsustaining very painful orthopedic emergency emergent procedures. As secondary objectives,
      we will study the characteristics of sedations obtained (level, delays, lengths); the Delays,
      lengths and levels of sedation obtained, overall delivered doses of propofol administered;
      the , nature, appearance delays and lengths of potential adverse events (AE) related to
      procedural sedation, particularly complications related to procedural sedation, and necessary
      interventions necessary to handle these AE., will be studied as secondary objectives
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Propofol brain concentration
time frame: Between the beginning of sedation (T0) and the beginning of the orthopedic procedure (T_Ramsay5)
description: Propofol brain concentration necessary for the patient to reach a Ramsay score of 5 (optimal sedation) (Ce_Ramsay5)
measure: Delay between the beginning of sedation (T0) and the beginning of the orthopedic procedure (T_Ramsay5)
time frame: the delay is the outcome, T_Ramsay5 (up to an anticipated average maximal time of 15 minutes after T0)]
description: the delay is the outcome, T_Ramsay5 (up to an anticipated average maximal time of 15 minutes after T0)]
measure: Propofol brain concentration when the patient spontaneously reopen his eyes (Ce_OuvertureYeux)
time frame: Time after T0 when the patient spontaneously reopen his eyes (up to an anticipated average maximal time of 30 minutes after T0)
description: Propofol brain concentration when the patient spontaneously reopen his eyes after the orthopedic procedure has been realized, the TCI syringe been switched off, and the immobilization been placed (Ce_OuvertureYeux)
arm group label: Target-controlled infusion (TCI)
arm group type: Experimental
description: Target-controlled infusion (TCI) with propofol up to 5.5µg/ml during an anticipated average maximal time of 15 minutes
intervention type: Drug
intervention name: Target control infusion with propofol
description: Target control infusion with propofol for patients with indications of sustaining very painful orthopedic emergency emergent procedures
arm group label: Target-controlled infusion (TCI)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fabien LEMOEL, PhD
role: Principal Investigator
affiliation: Emergency Department, Universitary Hospital of Nice
last name: Fabien LEMOEL, PhD
phone: 0492038535
phone ext: 0033
email: lemoel.f@chu-nice.fr
last name: Jocelyn RAPP
phone: 0492038535
phone ext: 0033
email: rapp.j@chu-nice.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Joint Dislocations
mesh term: Emergencies
mesh term: Propofol
sharing ipd: No