<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/NCT02193412</url>
  </required_header>
  <id_info>
    <org_study_id>2013_13</org_study_id>
    <secondary_id>2013-A01645-40</secondary_id>
    <nct_id>NCT02193412</nct_id>
  </id_info>
  <brief_title>Influence of Variations of Systemic Venous Return on Analgesia Nociception Index (ANI) During General Anaesthesia</brief_title>
  <official_title>Influence of Variations of Systemic Venous Return on Analgesia Nociception Index (ANI) During General Anaesthesia</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether the value of analgesia nociception index&#xD;
      (ANI) is influenced by variations of systemic venous return (cardiac preload) under general&#xD;
      anaesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the context of opioid sparing goal during general anaesthesia, the Analgesia nociception&#xD;
      index (ANI) is an analgesia/nociception balance monitoring tool computed from high frequency&#xD;
      heart rate variability analysis, and developed by MetroDoloris (Lille, France). Its&#xD;
      sensitivity to detect noxious stimulus was studied in several studies. However, its&#xD;
      specificity is not established in particular in the presence of factors influencing autonomic&#xD;
      nervous system other than analgesia/nociception balance. In the context of anaesthesia, one&#xD;
      of the most relevant factor is hypovolemia. This study aims to assess the effect of blood&#xD;
      volume variations on ANI under general anaesthesia, independently of analgesia/nociception&#xD;
      balance status. Variations of systemic venous return (SVR) (cardiac preload), which reflects&#xD;
      blood volume status, will be induced by changes of operating table slope, from head-down tilt&#xD;
      (Trendelenburg), with increased SVR, to head-up tilt position, with decreased SVR. Variations&#xD;
      of SVR will be attested by changes in the arterial pulse pressure variation, a&#xD;
      well-established indice of preload responsiveness in the mechanically ventilated&#xD;
      anaesthetized patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2015</start_date>
  <completion_date type="Actual">October 3, 2017</completion_date>
  <primary_completion_date type="Actual">October 3, 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 in ANI between head-down tilt (Trendelenburg) position and head-up tilt position</measure>
    <time_frame>during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)</time_frame>
    <description>Position -20° to +20°</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in ANI between horizontal position and head-down/head up tilt position</measure>
    <time_frame>during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)</time_frame>
    <description>Position 0° to -20° Position +20° to 0°</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in pulse pressure variation between head-down tilt position and head-up tilt position</measure>
    <time_frame>during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)</time_frame>
    <description>Position -20° to +20°</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in ANI induced by standardized noxious stimulus (tetanic stimulation)</measure>
    <time_frame>during a 5sec-tetanic stimulation (measurement for 1-2 min, 2-5 min after initial measurements in basal conditions)</time_frame>
    <description>ANI measurement following tetanus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>variations of low frequency variability of arterial blood pressure</measure>
    <time_frame>during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)</time_frame>
    <description>Position 0° to -20° Position -20° to +20° Position +20° to 0°</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in pulse pressure variation between horizontal position and head-down/head up tilt position</measure>
    <time_frame>during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)</time_frame>
    <description>Position 0° to -20° Position +20° to 0°</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Hypovolemia</condition>
  <condition>Somatic Pain</condition>
  <arm_group>
    <arm_group_label>patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>noxious stimulus&#xD;
change in operating table slope: head-down tilt position&#xD;
change in operating table slope: head-up tilt position</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>noxious stimulus</intervention_name>
    <description>standardized noxious stimulus with tetanic stimulation</description>
    <arm_group_label>patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>change in operating table slope: head-down tilt position</intervention_name>
    <description>-30°</description>
    <arm_group_label>patients</arm_group_label>
    <other_name>Trendelenburg position</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>change in operating table slope: head-up tilt position</intervention_name>
    <description>+30°</description>
    <arm_group_label>patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  neurosurgical operation requiring invasive monitoring of arterial blood pressure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pacemaker, arrhythmia&#xD;
&#xD;
          -  chronic medication with beta blocker&#xD;
&#xD;
          -  possible disorder of autonomic nervous system: diabetes, alcoholism, chronic pain&#xD;
&#xD;
          -  anticholinergic drug administration before measures&#xD;
&#xD;
          -  intracranial hypertension&#xD;
&#xD;
          -  no social security coverage&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benoît Tavernier, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lille University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Délégation à la Recherche Clinique et à l'Innovation (DRC)</last_name>
    <role>Study Chair</role>
    <affiliation>Lille University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Lille</city>
        <state>Nord</state>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>October 12, 2020</last_update_submitted>
  <last_update_submitted_qc>October 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>analgesia nociception index</keyword>
  <keyword>heart rate variability</keyword>
  <keyword>autonomic nervous system</keyword>
  <keyword>specificity</keyword>
  <keyword>systemic venous return</keyword>
  <keyword>pulse pressure variation</keyword>
  <keyword>Intraoperative Monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypovolemia</mesh_term>
    <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/NCT02193412
org study id: 2013_13
secondary id: 2013-A01645-40
nct id: NCT02193412
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether the value of analgesia nociception index
      (ANI) is influenced by variations of systemic venous return (cardiac preload) under general
      anaesthesia.
In the context of opioid sparing goal during general anaesthesia, the Analgesia nociception
      index (ANI) is an analgesia/nociception balance monitoring tool computed from high frequency
      heart rate variability analysis, and developed by MetroDoloris (Lille, France). Its
      sensitivity to detect noxious stimulus was studied in several studies. However, its
      specificity is not established in particular in the presence of factors influencing autonomic
      nervous system other than analgesia/nociception balance. In the context of anaesthesia, one
      of the most relevant factor is hypovolemia. This study aims to assess the effect of blood
      volume variations on ANI under general anaesthesia, independently of analgesia/nociception
      balance status. Variations of systemic venous return (SVR) (cardiac preload), which reflects
      blood volume status, will be induced by changes of operating table slope, from head-down tilt
      (Trendelenburg), with increased SVR, to head-up tilt position, with decreased SVR. Variations
      of SVR will be attested by changes in the arterial pulse pressure variation, a
      well-established indice of preload responsiveness in the mechanically ventilated
      anaesthetized patient.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: change in ANI between head-down tilt (Trendelenburg) position and head-up tilt position
time frame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
description: Position -20° to +20°
measure: change in ANI between horizontal position and head-down/head up tilt position
time frame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
description: Position 0° to -20° Position +20° to 0°
measure: change in pulse pressure variation between head-down tilt position and head-up tilt position
time frame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
description: Position -20° to +20°
measure: change in ANI induced by standardized noxious stimulus (tetanic stimulation)
time frame: during a 5sec-tetanic stimulation (measurement for 1-2 min, 2-5 min after initial measurements in basal conditions)
description: ANI measurement following tetanus
measure: variations of low frequency variability of arterial blood pressure
time frame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
description: Position 0° to -20° Position -20° to +20° Position +20° to 0°
measure: change in pulse pressure variation between horizontal position and head-down/head up tilt position
time frame: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
description: Position 0° to -20° Position +20° to 0°
arm group label: patients
arm group type: Experimental
description: noxious stimulus
change in operating table slope: head-down tilt position
change in operating table slope: head-up tilt position
intervention type: Procedure
intervention name: noxious stimulus
description: standardized noxious stimulus with tetanic stimulation
arm group label: patients
intervention type: Procedure
intervention name: change in operating table slope: head-down tilt position
description: -30°
arm group label: patients
other name: Trendelenburg position
intervention type: Procedure
intervention name: change in operating table slope: head-up tilt position
description: +30°
arm group label: patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Benoît Tavernier, Pr
role: Principal Investigator
affiliation: Lille University Hospital
last name: Délégation à la Recherche Clinique et à l'Innovation (DRC)
role: Study Chair
affiliation: Lille University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Hypovolemia
mesh term: Nociceptive Pain