<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/NCT03756233</url>
  </required_header>
  <id_info>
    <org_study_id>SMC2018-07-153</org_study_id>
    <nct_id>NCT03756233</nct_id>
  </id_info>
  <brief_title>Gradual Withdrawal of Remifentanil Infusion Reduced Postoperative Pain and Opioid Requirement During Breast Surgery</brief_title>
  <official_title>Gradual Withdrawal of Remifentanil Infusion Reduced Postoperative Pain and Opioid Requirement During Breast Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>No</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>
      Although remifentanil provides profound analgesia during operation, postoperative occurrence&#xD;
      of hyperalgesia and tolerance after remifentanil administration could be a challenge to the&#xD;
      postoperative pain control. Evaluation of analgesia and anti-nociception during anesthesia is&#xD;
      still a challenging issue. Surgical Pleth Index (SPI) is a non-invasive and simple access&#xD;
      tool used to monitor autonomous nervous system during anesthesia. This technique is based on&#xD;
      photoplethysmographic wave and heart beat analysis. SPI values range between 0 (no stress)&#xD;
      and 100 (high stress level). The purpose of this study was to determine the appropriate use&#xD;
      of Remifentanil for pain control in patients with SPI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients were randomized into either SPI-guided analgesia or standard practice (Control). In&#xD;
      both groups, anesthesia was maintained with total intravenous anaesthesia(TIVA) to keep&#xD;
      bispectral index values between 40 and 60.&#xD;
&#xD;
      In the Remifentanil gradual reduction group (test group), 20 minutes before the end of the&#xD;
      operation, remifentanil was gradually decreased by 25% every 5 minutes. The control group&#xD;
      stopped remifentanil 10 minutes before the end of the operation.&#xD;
&#xD;
      SPI was recorded before the intubation, after the intubation, directly before the end of&#xD;
      surgery. The number of unwanted somatic events, hemodynamics, Patient-controlled&#xD;
      analgesia(PCA) consumption, narcotic analgesics consumption, and recovery times were&#xD;
      recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 26, 2018</start_date>
  <completion_date type="Actual">July 3, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</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>Crossover Assignment</intervention_model>
    <intervention_model_description>In this study, remifentanil gradually withdrawal goup (test group) and remifentanil immediately stop group (control group) were divided into two groups. In the Remifentanil gradual reduction group (test group), 20 minutes before the end of the operation, remifentanil was gradually decreased by 25% every 5 minutes. The control group stopped remifentanil 10 minutes before the end of the operation.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric Rating Scale(NRS)</measure>
    <time_frame>postoperative 1 hour</time_frame>
    <description>The difference of postoperative highest pain score (NRS) between two groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SPI</measure>
    <time_frame>intraoperative (after the laryngeal mask airway)</time_frame>
    <description>The difference of Surgical Pleth Index between two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SPI</measure>
    <time_frame>intraoperative (after the incision)</time_frame>
    <description>The difference of Surgical Pleth Index between two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>analgesics consumption</measure>
    <time_frame>during post-anesthesia care unit</time_frame>
    <description>The difference of analgesics consumption between two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>analgesics consumption</measure>
    <time_frame>up to postoperative 48hours</time_frame>
    <description>The difference of analgesics consumption between two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>nausea &amp; vomiting</measure>
    <time_frame>postoperative 1 hour</time_frame>
    <description>The difference of nausea and vomiting between two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Rating Scale(NRS)</measure>
    <time_frame>during postoperative 48hours</time_frame>
    <description>The difference of highest postoperative pain score (NRS) between two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the duration of eye opening</measure>
    <time_frame>end of surgery</time_frame>
    <description>the duration of eye opening after stoping propofol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intraoperative remifentanil consumption</measure>
    <time_frame>intraoperative</time_frame>
    <description>the dose of intraoperative remifentanil according to postoperative pain</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Remifentanil gradually withdrawal group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 minutes before the end of the operation, remifentanil was gradually decreased by 25% every 5 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Remifentanil immediately stop group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group stopped remifentanil 10 minutes before the end of the operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remifentanil</intervention_name>
    <description>Remifentanil is a potent, short-acting synthetic opioid analgesic drug. It is given to patients during surgery to relieve pain and as an adjunct to an anesthetic.</description>
    <arm_group_label>Remifentanil gradually withdrawal group</arm_group_label>
    <arm_group_label>Remifentanil immediately stop group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who received the breast conserving surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with arrhythmia who have poor SPI measurement&#xD;
&#xD;
          -  When the patient refused&#xD;
&#xD;
          -  Patients with decreased renal function of Cr&gt; 2&#xD;
&#xD;
          -  Surgery for more than 3 hours, surgery expected to bleed more than 500 ml&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>sehee kang, fellow</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Gangnam-gu</state>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>October 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>September 8, 2019</last_update_submitted>
  <last_update_submitted_qc>September 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2019</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>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remifentanil</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/NCT03756233
org study id: SMC2018-07-153
nct id: NCT03756233
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Although remifentanil provides profound analgesia during operation, postoperative occurrence
      of hyperalgesia and tolerance after remifentanil administration could be a challenge to the
      postoperative pain control. Evaluation of analgesia and anti-nociception during anesthesia is
      still a challenging issue. Surgical Pleth Index (SPI) is a non-invasive and simple access
      tool used to monitor autonomous nervous system during anesthesia. This technique is based on
      photoplethysmographic wave and heart beat analysis. SPI values range between 0 (no stress)
      and 100 (high stress level). The purpose of this study was to determine the appropriate use
      of Remifentanil for pain control in patients with SPI.
Patients were randomized into either SPI-guided analgesia or standard practice (Control). In
      both groups, anesthesia was maintained with total intravenous anaesthesia(TIVA) to keep
      bispectral index values between 40 and 60.

      In the Remifentanil gradual reduction group (test group), 20 minutes before the end of the
      operation, remifentanil was gradually decreased by 25% every 5 minutes. The control group
      stopped remifentanil 10 minutes before the end of the operation.

      SPI was recorded before the intubation, after the intubation, directly before the end of
      surgery. The number of unwanted somatic events, hemodynamics, Patient-controlled
      analgesia(PCA) consumption, narcotic analgesics consumption, and recovery times were
      recorded.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: In this study, remifentanil gradually withdrawal goup (test group) and remifentanil immediately stop group (control group) were divided into two groups. In the Remifentanil gradual reduction group (test group), 20 minutes before the end of the operation, remifentanil was gradually decreased by 25% every 5 minutes. The control group stopped remifentanil 10 minutes before the end of the operation.
primary purpose: Supportive Care
masking: Single (Participant)
measure: Numeric Rating Scale(NRS)
time frame: postoperative 1 hour
description: The difference of postoperative highest pain score (NRS) between two groups
measure: SPI
time frame: intraoperative (after the laryngeal mask airway)
description: The difference of Surgical Pleth Index between two groups
measure: SPI
time frame: intraoperative (after the incision)
description: The difference of Surgical Pleth Index between two groups
measure: analgesics consumption
time frame: during post-anesthesia care unit
description: The difference of analgesics consumption between two groups
measure: analgesics consumption
time frame: up to postoperative 48hours
description: The difference of analgesics consumption between two groups
measure: nausea & vomiting
time frame: postoperative 1 hour
description: The difference of nausea and vomiting between two groups
measure: Numeric Rating Scale(NRS)
time frame: during postoperative 48hours
description: The difference of highest postoperative pain score (NRS) between two groups
measure: the duration of eye opening
time frame: end of surgery
description: the duration of eye opening after stoping propofol
measure: intraoperative remifentanil consumption
time frame: intraoperative
description: the dose of intraoperative remifentanil according to postoperative pain
arm group label: Remifentanil gradually withdrawal group
arm group type: Active Comparator
description: 20 minutes before the end of the operation, remifentanil was gradually decreased by 25% every 5 minutes.
arm group label: Remifentanil immediately stop group
arm group type: Active Comparator
description: The control group stopped remifentanil 10 minutes before the end of the operation.
intervention type: Drug
intervention name: Remifentanil
description: Remifentanil is a potent, short-acting synthetic opioid analgesic drug. It is given to patients during surgery to relieve pain and as an adjunct to an anesthetic.
arm group label: Remifentanil gradually withdrawal group
arm group label: Remifentanil immediately stop group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: sehee kang, fellow
role: Principal Investigator
affiliation: Samsung Medical Center
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Remifentanil