<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/NCT03749304</url>
  </required_header>
  <id_info>
    <org_study_id>2012_31</org_study_id>
    <secondary_id>2012-A01363-40</secondary_id>
    <nct_id>NCT03749304</nct_id>
  </id_info>
  <brief_title>Monitoring Analgesia by ANI (Analgesia The Nociception Index)</brief_title>
  <acronym>ANI-MICI</acronym>
  <official_title>Monitoring Analgesia by ANI (Analgesia The Nociception Index) During Surgery Inflammatory Bowel</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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>
      The objective of this research is to study the variations of the ANI(Analgesia The&#xD;
      Nociception Index) according to 2 periods: the &quot;NoStim&quot; period before surgical incision under&#xD;
      general anesthesia and the period of hemodynamic reactivity &quot;ReactHemo&quot; peroperative. This&#xD;
      period is defined by a 20% increase in FC and / or PAS (the only gold standard today).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 16, 2014</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>N/A</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of ANI greater than 20 points</measure>
    <time_frame>During the surgery, an average Three hours and a half</time_frame>
    <description>ANI decrease greater than 20 points between a &quot;NoStim&quot; period before surgical incision under general anesthesia and a period of intraoperative &quot;ReactHemo&quot; hemodynamic reactivity defined by a 20% increase in FC and / or PAS.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Nociceptive Pain</condition>
  <condition>Surgical Procedure, Unspecified</condition>
  <arm_group>
    <arm_group_label>ANI monitor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ANI monitor</intervention_name>
    <description>experimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index</description>
    <arm_group_label>ANI monitor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient with IBD&#xD;
&#xD;
          -  Scheduled surgery: laparotomy or laparoscopic resection with high risk of&#xD;
             laparo-conversion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient included in another current study or the previous month&#xD;
&#xD;
          -  urgent surgery&#xD;
&#xD;
          -  toxicomania or receiving opioids preoperatively&#xD;
&#xD;
          -  pregnant woman&#xD;
&#xD;
          -  psychosis&#xD;
&#xD;
          -  betablocker treatment&#xD;
&#xD;
          -  diabetic dysautonomia&#xD;
&#xD;
          -  non-sinus heart rate&#xD;
&#xD;
          -  pacemaker heart transplant&#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>Gilles Lebuffe, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Claude Huriez, CHU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</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>Nociceptive Pain</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/NCT03749304
org study id: 2012_31
secondary id: 2012-A01363-40
nct id: NCT03749304
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this research is to study the variations of the ANI(Analgesia The
      Nociception Index) according to 2 periods: the "NoStim" period before surgical incision under
      general anesthesia and the period of hemodynamic reactivity "ReactHemo" peroperative. This
      period is defined by a 20% increase in FC and / or PAS (the only gold standard today).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change of ANI greater than 20 points
time frame: During the surgery, an average Three hours and a half
description: ANI decrease greater than 20 points between a "NoStim" period before surgical incision under general anesthesia and a period of intraoperative "ReactHemo" hemodynamic reactivity defined by a 20% increase in FC and / or PAS.
arm group label: ANI monitor
arm group type: Experimental
intervention type: Device
intervention name: ANI monitor
description: experimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index
arm group label: ANI monitor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gilles Lebuffe, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Nociceptive Pain