<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/NCT02998424</url>
  </required_header>
  <id_info>
    <org_study_id>PD and propofol</org_study_id>
    <nct_id>NCT02998424</nct_id>
  </id_info>
  <brief_title>Pupillary Diameter Under Different Concentrations of Propofol</brief_title>
  <official_title>Pupillary Diameter Without Stimulation Under Different Concentrations of Propofol Alone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital Armand Trousseau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital Armand Trousseau</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Resting pupillary diameter was measured at a randomized Effect-site target concentration of&#xD;
      propofol used as a sole anesthetic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>N/A</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pupillary diameter</measure>
    <time_frame>Instantaneous measure, 10 minutes after the beginning of the study period</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bispectral Index (BIS)</measure>
    <time_frame>continuous measure, recorded10 minutes after the beginning of the study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>continuous measure, recorded10 minutes after the beginning of the study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observer's Assessment of Alertness/Sedation Scale (OAAS)</measure>
    <time_frame>10 minutes after the beginning of the study</time_frame>
    <description>Clinical score</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Propofol 1 µg/ml</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received a propofol infusion at an effect-site concentration of 1 µg/ml at the beginning of induction of general anesthesia for elective surgery.&#xD;
Pupillary diameter measurement after 10 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propofol 2 µg/ml</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received a propofol infusion at an effect-site concentration of 2 µg/ml at the beginning of induction of general anesthesia for elective surgery.&#xD;
Pupillary diameter measurement after 10 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propofol 3 µg/ml</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received a propofol infusion at an effect-site concentration of 3 µg/ml at the beginning of induction of general anesthesia for elective surgery.&#xD;
Pupillary diameter measurement after 10 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Continuous infusion</description>
    <arm_group_label>Propofol 1 µg/ml</arm_group_label>
    <arm_group_label>Propofol 2 µg/ml</arm_group_label>
    <arm_group_label>Propofol 3 µg/ml</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pupillary diameter measurement</intervention_name>
    <description>Instantaneous measure</description>
    <arm_group_label>Propofol 1 µg/ml</arm_group_label>
    <arm_group_label>Propofol 2 µg/ml</arm_group_label>
    <arm_group_label>Propofol 3 µg/ml</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient who has reached puberty&#xD;
&#xD;
          -  ASA I or II who is scheduled for elective surgery under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neurologic, metabolic, ocular disease&#xD;
&#xD;
          -  chronic pain&#xD;
&#xD;
          -  under medication that interferes with autonomic nervous system&#xD;
&#xD;
          -  obesity&#xD;
&#xD;
          -  patient requiering a rapid sequence induction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Isabelle Constant, MD-PHD</last_name>
    <role>Study Director</role>
    <affiliation>Hopital Armand Trousseau, Université Paris 6, Département d'anesthésie</affiliation>
  </overall_official>
  <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>June 2018</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>June 25, 2018</last_update_submitted>
  <last_update_submitted_qc>June 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal 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>propofol</keyword>
  <keyword>pupillary diameter</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</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/NCT02998424
org study id: PD and propofol
nct id: NCT02998424
lead sponsor: 
has dmc: No
Resting pupillary diameter was measured at a randomized Effect-site target concentration of
      propofol used as a sole anesthetic.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Pupillary diameter
time frame: Instantaneous measure, 10 minutes after the beginning of the study period
measure: Bispectral Index (BIS)
time frame: continuous measure, recorded10 minutes after the beginning of the study period
measure: Heart rate
time frame: continuous measure, recorded10 minutes after the beginning of the study period
measure: Observer's Assessment of Alertness/Sedation Scale (OAAS)
time frame: 10 minutes after the beginning of the study
description: Clinical score
arm group label: Propofol 1 µg/ml
arm group type: Experimental
description: Patients received a propofol infusion at an effect-site concentration of 1 µg/ml at the beginning of induction of general anesthesia for elective surgery.
Pupillary diameter measurement after 10 minutes.
arm group label: Propofol 2 µg/ml
arm group type: Experimental
description: Patients received a propofol infusion at an effect-site concentration of 2 µg/ml at the beginning of induction of general anesthesia for elective surgery.
Pupillary diameter measurement after 10 minutes.
arm group label: Propofol 3 µg/ml
arm group type: Experimental
description: Patients received a propofol infusion at an effect-site concentration of 3 µg/ml at the beginning of induction of general anesthesia for elective surgery.
Pupillary diameter measurement after 10 minutes.
intervention type: Drug
intervention name: Propofol
description: Continuous infusion
arm group label: Propofol 1 µg/ml
arm group label: Propofol 2 µg/ml
arm group label: Propofol 3 µg/ml
intervention type: Device
intervention name: Pupillary diameter measurement
description: Instantaneous measure
arm group label: Propofol 1 µg/ml
arm group label: Propofol 2 µg/ml
arm group label: Propofol 3 µg/ml
criteria: 
gender: All
minimum age: 13 Years
maximum age: 50 Years
healthy volunteers: No
last name: Isabelle Constant, MD-PHD
role: Study Director
affiliation: Hopital Armand Trousseau, Université Paris 6, Département d'anesthésie
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hôpital Armand Trousseau
investigator full name: Pr Isabelle CONSTANT
investigator title: Professor
mesh term: Propofol
sharing ipd: No