<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/NCT03749811</url>
  </required_header>
  <id_info>
    <org_study_id>1811-036-984</org_study_id>
    <nct_id>NCT03749811</nct_id>
  </id_info>
  <brief_title>Pupillometry-guided Remifentanil Infusion Versus Conventional Administration in Children</brief_title>
  <acronym>PURFT</acronym>
  <official_title>Comparison of Remifentanil Consumption in Pupillometry-guided Versus Conventional Administration in Pediatric Surgery: a Prospective, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</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>
      Our study aims to compare the total intravenous dose of remifentanil per anesthesia hour and&#xD;
      body weight in two groups of pediatric surgical patients - an interventional group with&#xD;
      remifentanil infusion under pupillometry monitoring, and control group without pupillometry -&#xD;
      to figure out whether pupillometry monitoring may reduce remifentanil consumption during&#xD;
      anesthesia while providing sufficient analgesia for surgical noxious stimuli.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      comparison of total used opioid&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 4, 2018</start_date>
  <completion_date type="Anticipated">November 18, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 18, 2020</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>Single Group Assignment</intervention_model>
    <intervention_model_description>Interventional group: remifentanil infusion under pupillometry monitoring. Control group: remifentanil infusion without pupillometry monitoring (remifentanil dose is determined by conventional method, i. e., hemodynamic change probably related to noxious stimuli)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participant does not know in which of the groups he/she is allocated. Only a care provider (an attending anesthesiologist who is responsible for the patient's anesthesia) knows the group which the patient belongs to.&#xD;
Investigator and outcomes assessor does not know in which of the groups the patient is allocated, since the group name will be just recorded as &quot;A&quot; or &quot;B&quot; until data analysis of the last participant is done.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>remifentanil total dose in microgram</measure>
    <time_frame>from beginning of anesthesia to the end of the anesthesia</time_frame>
    <description>Remifentanil total dose divided by anesthesia time (minute) and patient weight (kg).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FLACC score</measure>
    <time_frame>Arrival at the post-anesthesia care unit</time_frame>
    <description>FLACC score (a pain evaluation method for children who cannot express their severity of pain verbally) right after post-anesthesia care unit arrival.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adjusted analgesic dose after anesthesia</measure>
    <time_frame>24 hours after the end of anesthesia</time_frame>
    <description>Total dose of analgesics (NSAIDs and opioids) delivered to the patient since the end of the anesthesia, until 24 hours after the end of anesthesia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Emergence time</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Time between the end of the surgery and extubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of rescue therapy</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Incidence of vasopressor/inotropics/anticholinergics/fluid/vasodilators administered, due to moderate to severe hemodynamic change</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>Pupillometry group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A group of participants who receive remifentanil infusion under pupillometry monitoring.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A group of participants who receive remifentanil infusion without pupillometry monitoring; their analgesic dose is mainly determined via hemodyamic change.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pupillometry</intervention_name>
    <description>After induction of anesthesia and determination of the loss of consciousness of the participant, baseline diameter of pupil is measured by electronic pupillometry device. During anesthesia, participant's pupil diameter is repeatedly measured with 5-minute interval. Pupil dilation of 30% or more compared to baseline is indicative of insufficient analgesia.</description>
    <arm_group_label>Pupillometry group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients who are at 3 to 6 years of age, scheduled to undergo elective&#xD;
             surgery with estimated time of operation 2 hours or longer, under general anesthesia&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status classification (ASA class) I -&#xD;
             II&#xD;
&#xD;
          -  Patient and his/her parents are willing to participate after explanation of the&#xD;
             purpose, materials, methods, possible risks and benefits of the research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of hypersensitivity/allergic reaction to the drugs which are used in general&#xD;
             anesthesia&#xD;
&#xD;
          -  Preoperative use of analgesics, antipsychotics and/or antiepileptics&#xD;
&#xD;
          -  Mental retardation&#xD;
&#xD;
          -  Medications related to hindrance of autonomic nerve system activity, e. g., beta&#xD;
             blockers&#xD;
&#xD;
          -  Underlying ophthalmic diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hee-Soo Kim, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of Anesthesiology and Pain Medicine, Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hee-Soo Kim, M.D., Ph.D.</last_name>
    <phone>+82-2-2072-3664</phone>
    <email>dami0605@snu.ac.kr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sang-Whan Ji</last_name>
    <phone>+82-2-2072-3661</phone>
    <email>taepoongshin@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heesoo Kim</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Wildemeersch D, Peeters N, Saldien V, Vercauteren M, Hans G. Pain assessment by pupil dilation reflex in response to noxious stimulation in anaesthetized adults. Acta Anaesthesiol Scand. 2018 Apr 19;62(8):1050-6. doi: 10.1111/aas.13129. Online ahead of print.</citation>
    <PMID>29671874</PMID>
  </results_reference>
  <results_reference>
    <citation>Sabourdin N, Barrois J, Louvet N, Rigouzzo A, Guye ML, Dadure C, Constant I. Pupillometry-guided Intraoperative Remifentanil Administration versus Standard Practice Influences Opioid Use: A Randomized Study. Anesthesiology. 2017 Aug;127(2):284-292. doi: 10.1097/ALN.0000000000001705.</citation>
    <PMID>28719527</PMID>
  </results_reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 18, 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>March 27, 2019</last_update_submitted>
  <last_update_submitted_qc>March 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Hee-Soo Kim</investigator_full_name>
    <investigator_title>princial investigator</investigator_title>
  </responsible_party>
  <keyword>Pupil dilatory reflex</keyword>
  <keyword>Remifentanil</keyword>
  <keyword>Analgesia</keyword>
  <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/NCT03749811
org study id: 1811-036-984
nct id: NCT03749811
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Our study aims to compare the total intravenous dose of remifentanil per anesthesia hour and
      body weight in two groups of pediatric surgical patients - an interventional group with
      remifentanil infusion under pupillometry monitoring, and control group without pupillometry -
      to figure out whether pupillometry monitoring may reduce remifentanil consumption during
      anesthesia while providing sufficient analgesia for surgical noxious stimuli.
comparison of total used opioid
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: Interventional group: remifentanil infusion under pupillometry monitoring. Control group: remifentanil infusion without pupillometry monitoring (remifentanil dose is determined by conventional method, i. e., hemodynamic change probably related to noxious stimuli)
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Participant does not know in which of the groups he/she is allocated. Only a care provider (an attending anesthesiologist who is responsible for the patient's anesthesia) knows the group which the patient belongs to.
Investigator and outcomes assessor does not know in which of the groups the patient is allocated, since the group name will be just recorded as "A" or "B" until data analysis of the last participant is done.
measure: remifentanil total dose in microgram
time frame: from beginning of anesthesia to the end of the anesthesia
description: Remifentanil total dose divided by anesthesia time (minute) and patient weight (kg).
measure: FLACC score
time frame: Arrival at the post-anesthesia care unit
description: FLACC score (a pain evaluation method for children who cannot express their severity of pain verbally) right after post-anesthesia care unit arrival.
measure: Adjusted analgesic dose after anesthesia
time frame: 24 hours after the end of anesthesia
description: Total dose of analgesics (NSAIDs and opioids) delivered to the patient since the end of the anesthesia, until 24 hours after the end of anesthesia
measure: Emergence time
time frame: Intraoperative
description: Time between the end of the surgery and extubation
measure: Incidence of rescue therapy
time frame: Intraoperative
description: Incidence of vasopressor/inotropics/anticholinergics/fluid/vasodilators administered, due to moderate to severe hemodynamic change
arm group label: Pupillometry group
arm group type: Experimental
description: A group of participants who receive remifentanil infusion under pupillometry monitoring.
arm group label: Conventional group
arm group type: No Intervention
description: A group of participants who receive remifentanil infusion without pupillometry monitoring; their analgesic dose is mainly determined via hemodyamic change.
intervention type: Device
intervention name: Pupillometry
description: After induction of anesthesia and determination of the loss of consciousness of the participant, baseline diameter of pupil is measured by electronic pupillometry device. During anesthesia, participant's pupil diameter is repeatedly measured with 5-minute interval. Pupil dilation of 30% or more compared to baseline is indicative of insufficient analgesia.
arm group label: Pupillometry group
criteria: 
gender: All
minimum age: 3 Years
maximum age: 12 Years
healthy volunteers: No
last name: Hee-Soo Kim, M.D., Ph.D.
role: Principal Investigator
affiliation: Dept. of Anesthesiology and Pain Medicine, Seoul National University Hospital
last name: Hee-Soo Kim, M.D., Ph.D.
phone: +82-2-2072-3664
email: dami0605@snu.ac.kr
last name: Sang-Whan Ji
phone: +82-2-2072-3661
email: taepoongshin@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
citation: Wildemeersch D, Peeters N, Saldien V, Vercauteren M, Hans G. Pain assessment by pupil dilation reflex in response to noxious stimulation in anaesthetized adults. Acta Anaesthesiol Scand. 2018 Apr 19;62(8):1050-6. doi: 10.1111/aas.13129. Online ahead of print.
PMID: 29671874
citation: Sabourdin N, Barrois J, Louvet N, Rigouzzo A, Guye ML, Dadure C, Constant I. Pupillometry-guided Intraoperative Remifentanil Administration versus Standard Practice Influences Opioid Use: A Randomized Study. Anesthesiology. 2017 Aug;127(2):284-292. doi: 10.1097/ALN.0000000000001705.
PMID: 28719527
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Hee-Soo Kim
investigator title: princial investigator
sharing ipd: No