<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/NCT04465773</url>
  </required_header>
  <id_info>
    <org_study_id>Pupillo propofol remi stim</org_study_id>
    <nct_id>NCT04465773</nct_id>
  </id_info>
  <brief_title>Pupillary Response to Incremental Tetanic Stimulations Under Propofol-remifentanil TCI</brief_title>
  <official_title>Pupillary Diameter Variations in Response to Tetanic Stimulations of Incremental Intensities in Patients Under Propofol-remifentanil TCI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pr Isabelle CONSTANT</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital Armand Trousseau</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients under standardized steady-state general anesthesia, 6 tetanic stimulations of&#xD;
      incremental intensities were applied to the patients. Pupillary dilation in response to these&#xD;
      stimulations was recorded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study was to investigate a possible correlation between the intensity of a&#xD;
      nociceptive stimulus and the magnitude of pupillary reflex dilation in patients anesthetized&#xD;
      with propofol and remifentanil target-controlled infusion.&#xD;
&#xD;
      Anesthetic protocol: 10 minutes of steady-state general anesthesia (before extubation during&#xD;
      a scheduled gynecological surgery) with remifentanil target concentration of 1 ng/ml, and&#xD;
      propofol target concentration adjusted to maintain bispectral index between 45 and 55.&#xD;
&#xD;
      Study period: 6 tetanic stimulations of incremental intensities were applied to the patients:&#xD;
      10, 20, 30, 40, 50, 60 milliamps Pupillary dilation in response to these stimulations was&#xD;
      recorded.&#xD;
&#xD;
      Then, propofol and remifentanil infusions were discontinued, and patients were extubated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Pupillary diameter</measure>
    <time_frame>5 seconds before tetanic stimulation</time_frame>
    <description>as measured by VideoAlgesiGraph, in mm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pupillary diameter</measure>
    <time_frame>1 minute after tetanic stimulation</time_frame>
    <description>as measured by VideoAlgesiGraph, in mm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>5 seconds before tetanic stimulation</time_frame>
    <description>as measured by the standard cardioscope</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>1 minute after tetanic stimulation</time_frame>
    <description>as measured by the standard cardioscope</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>pupillometry</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>General anesthesia for scheduled gynecological surgery Propofol target concentration adjusted to maintain bispectral index between 45 and 55 for 10 minutes Remifentanil target concentration 1 ng/ml for 10 minutes Tetanic stimulations of 10-20-30-40-50-60 milliamps (5 seconds per stimulation, 2 minutes between stimulations) Continuous pupillometry VideoAlgesiGraph</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>general anesthesia for scheduled gynecological surgery</intervention_name>
    <arm_group_label>pupillometry</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>continuous infusion, target concentration adjusted to maintain bispectral index between 45 and 55</description>
    <arm_group_label>pupillometry</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remifentanil, Ultiva®</intervention_name>
    <description>continuous infusion, target concentration 1 ng/ml</description>
    <arm_group_label>pupillometry</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>tetanic stimulations</intervention_name>
    <description>10-20-30-40-50-60 milliamps, 5 seconds, 100 Hertz 2 minutes between stimulations delivered via the standard neuromuscular blocking agents monitor</description>
    <arm_group_label>pupillometry</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VideoAlgesiGraph</intervention_name>
    <description>non invasive infrared camera placed in front of the left eye of the patients during the study period, connected to a laptop. No part of the device touches the eye.</description>
    <arm_group_label>pupillometry</arm_group_label>
    <other_name>VideoAlgesiGraph, Synapsis (TM), Marseille, France</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled gynecological surgery requiring general anesthesia and orotracheal&#xD;
             intubation&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ophthalmic disease&#xD;
&#xD;
          -  neurologic disease&#xD;
&#xD;
          -  preoperative chronic pain or pain medication&#xD;
&#xD;
          -  medication interfering with autonomous nervous system (beta blockers, alpha agonists,&#xD;
             metoclopramide, droperidol, atropine, catecholamines)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Departement d'anesthesie Hopital Armand Trousseau</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 12, 2016</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hôpital Armand Trousseau</investigator_affiliation>
    <investigator_full_name>Pr Isabelle CONSTANT</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>general anesthesia</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remifentanil</mesh_term>
    <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/NCT04465773
org study id: Pupillo propofol remi stim
nct id: NCT04465773
lead sponsor: 
has dmc: Yes
In patients under standardized steady-state general anesthesia, 6 tetanic stimulations of
      incremental intensities were applied to the patients. Pupillary dilation in response to these
      stimulations was recorded.
The aim of the study was to investigate a possible correlation between the intensity of a
      nociceptive stimulus and the magnitude of pupillary reflex dilation in patients anesthetized
      with propofol and remifentanil target-controlled infusion.

      Anesthetic protocol: 10 minutes of steady-state general anesthesia (before extubation during
      a scheduled gynecological surgery) with remifentanil target concentration of 1 ng/ml, and
      propofol target concentration adjusted to maintain bispectral index between 45 and 55.

      Study period: 6 tetanic stimulations of incremental intensities were applied to the patients:
      10, 20, 30, 40, 50, 60 milliamps Pupillary dilation in response to these stimulations was
      recorded.

      Then, propofol and remifentanil infusions were discontinued, and patients were extubated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Pupillary diameter
time frame: 5 seconds before tetanic stimulation
description: as measured by VideoAlgesiGraph, in mm
measure: Pupillary diameter
time frame: 1 minute after tetanic stimulation
description: as measured by VideoAlgesiGraph, in mm
measure: Heart rate
time frame: 5 seconds before tetanic stimulation
description: as measured by the standard cardioscope
measure: Heart rate
time frame: 1 minute after tetanic stimulation
description: as measured by the standard cardioscope
arm group label: pupillometry
arm group type: Experimental
description: General anesthesia for scheduled gynecological surgery Propofol target concentration adjusted to maintain bispectral index between 45 and 55 for 10 minutes Remifentanil target concentration 1 ng/ml for 10 minutes Tetanic stimulations of 10-20-30-40-50-60 milliamps (5 seconds per stimulation, 2 minutes between stimulations) Continuous pupillometry VideoAlgesiGraph
intervention type: Procedure
intervention name: general anesthesia for scheduled gynecological surgery
arm group label: pupillometry
intervention type: Drug
intervention name: Propofol
description: continuous infusion, target concentration adjusted to maintain bispectral index between 45 and 55
arm group label: pupillometry
intervention type: Drug
intervention name: Remifentanil, Ultiva®
description: continuous infusion, target concentration 1 ng/ml
arm group label: pupillometry
intervention type: Procedure
intervention name: tetanic stimulations
description: 10-20-30-40-50-60 milliamps, 5 seconds, 100 Hertz 2 minutes between stimulations delivered via the standard neuromuscular blocking agents monitor
arm group label: pupillometry
intervention type: Device
intervention name: VideoAlgesiGraph
description: non invasive infrared camera placed in front of the left eye of the patients during the study period, connected to a laptop. No part of the device touches the eye.
arm group label: pupillometry
other name: VideoAlgesiGraph, Synapsis (TM), Marseille, France
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor-Investigator
investigator affiliation: Hôpital Armand Trousseau
investigator full name: Pr Isabelle CONSTANT
investigator title: Professor
mesh term: Remifentanil
mesh term: Propofol