<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/NCT02198404</url>
  </required_header>
  <id_info>
    <org_study_id>14-PP-01</org_study_id>
    <nct_id>NCT02198404</nct_id>
  </id_info>
  <brief_title>Pilot Study of Sedation With Propofol in Refractory Pains Due to Care in Palliative Care Unit</brief_title>
  <acronym>PROPOPAL1</acronym>
  <official_title>Pilot Study of Sedation With Propofol in Refractory Pains Due to Care in Palliative Care Unit</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the palliative care unit, certain patients suffer from pain associated with medical&#xD;
      procedures/care which is poorly controlled by antalgics. These situations may necessitate&#xD;
      temporary sedation to improve comfort and facilitate treatment. No proven consensus exists,&#xD;
      either in the literature or in clinical studies conducted, on the choice of sedative agent&#xD;
      however Midazolam is the general recommendation.&#xD;
&#xD;
      The investigators believe that Propofol could be used in this instance&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the palliative care unit, certain patients suffer from pain associated with medical&#xD;
      procedures/care which is poorly controlled by antalgics. These situations may necessitate&#xD;
      temporary sedation to improve comfort and facilitate treatment. No proven consensus exists,&#xD;
      either in the literature or in clinical studies conducted, on the choice of sedative agent&#xD;
      however Midazolam is the general recommendation.&#xD;
&#xD;
      The investigators believe that Propofol could be used in this instance. The arguments in&#xD;
      favour of Propofol include its pharmaco-kinetic characteristics and the fact that it is&#xD;
      currently used in other circumstances. Propofol has an action delay which is more rapid that&#xD;
      Midazolam therefore its effect is seen 1 minute after a bolus and 5 minutes after for&#xD;
      Midazolam. The effect after a short administration lasts only a few minutes however the&#xD;
      effect of Midazolam is more prolonged (sometimes several hours). As with Midazolam, a&#xD;
      titrated use in weaker doses, should allow sufficient sedation, in the context which&#xD;
      interests us, without marked secondary effects.&#xD;
&#xD;
      It is not unreasonable to think that the short action duration of Propofol could minimise&#xD;
      respiratory risks in the hours after the treatment compared to Midazolam. With Propofol, the&#xD;
      patient wakes as soon as the painful medical procedure has finished, with Midazolam sedation&#xD;
      may be prolonged to several hours leading to a risk respiratory depression or secretion&#xD;
      retention.&#xD;
&#xD;
      For these reasons; the investigators would like to verify that the use of Propofol is&#xD;
      feasible in the context of refractory pain associated with medical procedures (dressing&#xD;
      changes, movement during personal care tasks e.g. washing) in the palliative care unit. This&#xD;
      is a preliminary study prior to completion of a more extensive multi-centre research project&#xD;
      on the role Propofol could play in this situation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">February 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasability of the care without largely pain</measure>
    <time_frame>at inclusion (day=0), after the care</time_frame>
    <description>The nurse assess if the care could be done without largely pain for the patient. The answer would be &quot;yes&quot; or &quot;not&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>asleep delay</measure>
    <time_frame>at the inclusion (day=0), delay between sleep-inducing medicine injection and asleep</time_frame>
    <description>time in minutes between injection of propofol and sleep of patient</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Refractory Pains</condition>
  <condition>End of Life Patients</condition>
  <arm_group>
    <arm_group_label>sedation with propofol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>propofol injection: induction with propofol at 20 mg/kg/h. When patient is sleeping, the dosage is deceased to 6 mg/kg/h</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sedation with propofol</intervention_name>
    <description>induction with propofol at 20mg/kg/h. Then, when the patient is sleeping, dosage is decreased to 6 mg/kg/h</description>
    <arm_group_label>sedation with propofol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients hospitalized in palliative care unit&#xD;
&#xD;
          -  dying terminally patients&#xD;
&#xD;
          -  pains resisting to fentanyl and MEOPA (Melange equimolaire Oxygène protocyde d'Azote)&#xD;
             (EMONO = equimolar mixture of oxygene and nitrous oxide)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contra-indication to soya&#xD;
&#xD;
          -  contra-indication to egg lecithin&#xD;
&#xD;
          -  Respiratory insufficiency&#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>CIAIS Jean-François, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nice University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>CIAIS JEAN-FRANCOIS, PhD</last_name>
    <email>ciais.jf@chu-nice.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nice University Hospital</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>JEAN-FRANCOIS CIAIS, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>FLORA TREMELLAT, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>MAUD CASTELLI PRIETO, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>March 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>September 29, 2015</last_update_submitted>
  <last_update_submitted_qc>September 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Death</mesh_term>
    <mesh_term>Pain, Intractable</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
  </intervention_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/NCT02198404
org study id: 14-PP-01
nct id: NCT02198404
lead sponsor: 
has dmc: No
In the palliative care unit, certain patients suffer from pain associated with medical
      procedures/care which is poorly controlled by antalgics. These situations may necessitate
      temporary sedation to improve comfort and facilitate treatment. No proven consensus exists,
      either in the literature or in clinical studies conducted, on the choice of sedative agent
      however Midazolam is the general recommendation.

      The investigators believe that Propofol could be used in this instance
In the palliative care unit, certain patients suffer from pain associated with medical
      procedures/care which is poorly controlled by antalgics. These situations may necessitate
      temporary sedation to improve comfort and facilitate treatment. No proven consensus exists,
      either in the literature or in clinical studies conducted, on the choice of sedative agent
      however Midazolam is the general recommendation.

      The investigators believe that Propofol could be used in this instance. The arguments in
      favour of Propofol include its pharmaco-kinetic characteristics and the fact that it is
      currently used in other circumstances. Propofol has an action delay which is more rapid that
      Midazolam therefore its effect is seen 1 minute after a bolus and 5 minutes after for
      Midazolam. The effect after a short administration lasts only a few minutes however the
      effect of Midazolam is more prolonged (sometimes several hours). As with Midazolam, a
      titrated use in weaker doses, should allow sufficient sedation, in the context which
      interests us, without marked secondary effects.

      It is not unreasonable to think that the short action duration of Propofol could minimise
      respiratory risks in the hours after the treatment compared to Midazolam. With Propofol, the
      patient wakes as soon as the painful medical procedure has finished, with Midazolam sedation
      may be prolonged to several hours leading to a risk respiratory depression or secretion
      retention.

      For these reasons; the investigators would like to verify that the use of Propofol is
      feasible in the context of refractory pain associated with medical procedures (dressing
      changes, movement during personal care tasks e.g. washing) in the palliative care unit. This
      is a preliminary study prior to completion of a more extensive multi-centre research project
      on the role Propofol could play in this situation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasability of the care without largely pain
time frame: at inclusion (day=0), after the care
description: The nurse assess if the care could be done without largely pain for the patient. The answer would be "yes" or "not"
measure: asleep delay
time frame: at the inclusion (day=0), delay between sleep-inducing medicine injection and asleep
description: time in minutes between injection of propofol and sleep of patient
arm group label: sedation with propofol
arm group type: Experimental
description: propofol injection: induction with propofol at 20 mg/kg/h. When patient is sleeping, the dosage is deceased to 6 mg/kg/h
intervention type: Drug
intervention name: sedation with propofol
description: induction with propofol at 20mg/kg/h. Then, when the patient is sleeping, dosage is decreased to 6 mg/kg/h
arm group label: sedation with propofol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: CIAIS Jean-François, PhD
role: Principal Investigator
affiliation: Nice University Hospital
last name: CIAIS JEAN-FRANCOIS, PhD
email: ciais.jf@chu-nice.fr
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Death
mesh term: Pain, Intractable
mesh term: Propofol