<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/NCT02206022</url>
  </required_header>
  <id_info>
    <org_study_id>13 6932 03</org_study_id>
    <nct_id>NCT02206022</nct_id>
  </id_info>
  <brief_title>Remifentanil And Local Anesthesia Compared With Local Anesthesia For The Insertion Of Central Venous Catheters</brief_title>
  <acronym>REMIDOLCATH</acronym>
  <official_title>REMIFENTANIL AND LOCAL ANESTHESIA COMPARED WITH LOCAL ANESTHESIA FOR THE INSERTION OF CENTRAL VENOUS CATHETERS IN AWAKE PATIENTS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      At present, there is no reference protocol for Central Venous Catheter (CVC) insertion&#xD;
      assuring analgesia, anxiolysis and safety. Medical teams use various levels of analgesia and&#xD;
      anesthesia to realize this gesture, from single local anesthesia to general anesthesia.&#xD;
      Remifentanil has been shown to decrease pain scores for insertion and removal of long-term&#xD;
      central venous access. Remifentanil is also often employed for pediatric or labor analgesia&#xD;
      for short acts as procedural sedation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximal pain score on numeric rating scale (NRS) will be assessed after the insertion</measure>
    <time_frame>up to 60 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of patient's anxiety by the Face Anxiety Scale</measure>
    <time_frame>up to 60 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient and physician's satisfaction by a 10-points numeric rating scale</measure>
    <time_frame>up to 60 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>up to 60 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of realized punctions</measure>
    <time_frame>up to 60 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Local Anesthesia</condition>
  <arm_group>
    <arm_group_label>Remifentanil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who undergone a Central Venous Catheter (CVC) insertion under remifentanil infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients who undergone a Central Venous Catheter (CVC) insertion under placebo infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remifentanil</intervention_name>
    <description>Pain's evaluation for Remifentanil Group</description>
    <arm_group_label>Remifentanil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>CVC pain's evaluation after local anesthesia + placebo infusion</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  more than 18 years old&#xD;
&#xD;
          -  eligible for CVC insertion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  patients who can't give their consent&#xD;
&#xD;
          -  contra-indications to remifentanil infusion&#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>Jean RUIZ, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Vardon Bounes F, Pichon X, Ducos G, Ruiz J, Samier C, Silva S, Sommet A, Fourcade O, Conil JM, Minville V. Remifentanil for Procedural Sedation and Analgesia in Central Venous Catheter Insertion: A Randomized, Controlled Trial. Clin J Pain. 2019 Aug;35(8):691-695. doi: 10.1097/AJP.0000000000000725.</citation>
    <PMID>31094935</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>March 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Central Venous Catheter</keyword>
  <keyword>Remifentanil</keyword>
  <keyword>local anesthesia</keyword>
  <keyword>pain</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remifentanil</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/NCT02206022
org study id: 13 6932 03
nct id: NCT02206022
lead sponsor: 
has dmc: No
At present, there is no reference protocol for Central Venous Catheter (CVC) insertion
      assuring analgesia, anxiolysis and safety. Medical teams use various levels of analgesia and
      anesthesia to realize this gesture, from single local anesthesia to general anesthesia.
      Remifentanil has been shown to decrease pain scores for insertion and removal of long-term
      central venous access. Remifentanil is also often employed for pediatric or labor analgesia
      for short acts as procedural sedation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Maximal pain score on numeric rating scale (NRS) will be assessed after the insertion
time frame: up to 60 minutes
measure: Evaluation of patient's anxiety by the Face Anxiety Scale
time frame: up to 60 minutes
measure: Patient and physician's satisfaction by a 10-points numeric rating scale
time frame: up to 60 minutes
measure: Number of adverse events
time frame: up to 60 minutes
measure: Number of realized punctions
time frame: up to 60 minutes
arm group label: Remifentanil
arm group type: Experimental
description: Patients who undergone a Central Venous Catheter (CVC) insertion under remifentanil infusion
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients who undergone a Central Venous Catheter (CVC) insertion under placebo infusion
intervention type: Drug
intervention name: Remifentanil
description: Pain's evaluation for Remifentanil Group
arm group label: Remifentanil
intervention type: Drug
intervention name: Placebo
description: CVC pain's evaluation after local anesthesia + placebo infusion
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean RUIZ, MD, PhD
role: Principal Investigator
affiliation: CHU Toulouse
facility: 
country: France
citation: Vardon Bounes F, Pichon X, Ducos G, Ruiz J, Samier C, Silva S, Sommet A, Fourcade O, Conil JM, Minville V. Remifentanil for Procedural Sedation and Analgesia in Central Venous Catheter Insertion: A Randomized, Controlled Trial. Clin J Pain. 2019 Aug;35(8):691-695. doi: 10.1097/AJP.0000000000000725.
PMID: 31094935
responsible party type: Sponsor
mesh term: Remifentanil
sharing ipd: No