<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/NCT04409964</url>
  </required_header>
  <id_info>
    <org_study_id>OFGA</org_study_id>
    <nct_id>NCT04409964</nct_id>
  </id_info>
  <brief_title>the Effect of Opioid-free General Anesthesia</brief_title>
  <official_title>the Effect of Opioid-free General Anesthesia on the Recovery Quality After Gynecological Laparoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Catholic University of Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Catholic University of Korea</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is performed to investigate the effect of opioid-free general anesthesia on the&#xD;
      recovery quality after gynecological laparoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The quality of recovery after the surgery is assessed using the QoR 40. In addition, the&#xD;
      various kinds of cytokine are assessed for the ancillary study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">September 20, 2021</completion_date>
  <primary_completion_date type="Actual">September 1, 2021</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the quality of recovery</measure>
    <time_frame>at 24 hour after the completion of surgery</time_frame>
    <description>The quality of recovery is assessed using questionnaire. This questionnaire includes 40 items. The score range is from 40 to 200. The higher score means the better quality of recovery after surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cytokine</measure>
    <time_frame>during surgery</time_frame>
    <description>as ancillary study, to assess the various kinds of cytokines such as epinephrine, norepinephrine, interleukin-10, tumor necrosis factor-alpha.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Gynecologic Disease</condition>
  <arm_group>
    <arm_group_label>opioid-free anesthesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>opioid anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group receives the remifentanil infusion with general anesthesia for gynecological laparoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine Hydrochloride</intervention_name>
    <description>dexmedetomidine iv bolus followed by the infusion of 0.1-1 ug/kg/hr during general anesthesia</description>
    <arm_group_label>opioid-free anesthesia</arm_group_label>
    <other_name>precedex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine Hydrochloride</intervention_name>
    <description>lidocaine iv bolus followed by the infusion of 1.5 mg/kg/hr during general anesthesia</description>
    <arm_group_label>opioid-free anesthesia</arm_group_label>
    <other_name>lidocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remifentanil Hydrochloride</intervention_name>
    <description>remifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia</description>
    <arm_group_label>opioid anesthesia</arm_group_label>
    <other_name>remifentanil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient scheduled for gynecological laparoscopic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. refusal to participate in this study&#xD;
&#xD;
          2. emergent surgery&#xD;
&#xD;
          3. chronic pain requiring for pain killer&#xD;
&#xD;
          4. psychiatric disease&#xD;
&#xD;
          5. preoperative bradycardia or hypotension&#xD;
&#xD;
          6. allergy or history of the adverse effect to study drug&#xD;
&#xD;
          7. pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>the patients undergoing the gynecological laparoscopic surgery</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Youngeun Moon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul St. Mary's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul St.Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Seocho-gu</state>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul St.Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Seocho-gu</state>
        <zip>07651</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>February 20, 2022</last_update_submitted>
  <last_update_submitted_qc>February 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Catholic University of Korea</investigator_affiliation>
    <investigator_full_name>Young Eun Moon</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Genital Diseases, Female</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Remifentanil</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/NCT04409964
org study id: OFGA
nct id: NCT04409964
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study is performed to investigate the effect of opioid-free general anesthesia on the
      recovery quality after gynecological laparoscopy.
The quality of recovery after the surgery is assessed using the QoR 40. In addition, the
      various kinds of cytokine are assessed for the ancillary study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: the quality of recovery
time frame: at 24 hour after the completion of surgery
description: The quality of recovery is assessed using questionnaire. This questionnaire includes 40 items. The score range is from 40 to 200. The higher score means the better quality of recovery after surgery.
measure: cytokine
time frame: during surgery
description: as ancillary study, to assess the various kinds of cytokines such as epinephrine, norepinephrine, interleukin-10, tumor necrosis factor-alpha.
arm group label: opioid-free anesthesia
arm group type: Experimental
description: The study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy.
arm group label: opioid anesthesia
arm group type: Active Comparator
description: The control group receives the remifentanil infusion with general anesthesia for gynecological laparoscopy.
intervention type: Drug
intervention name: Dexmedetomidine Hydrochloride
description: dexmedetomidine iv bolus followed by the infusion of 0.1-1 ug/kg/hr during general anesthesia
arm group label: opioid-free anesthesia
other name: precedex
intervention type: Drug
intervention name: Lidocaine Hydrochloride
description: lidocaine iv bolus followed by the infusion of 1.5 mg/kg/hr during general anesthesia
arm group label: opioid-free anesthesia
other name: lidocaine
intervention type: Drug
intervention name: Remifentanil Hydrochloride
description: remifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia
arm group label: opioid anesthesia
other name: remifentanil
criteria: 
gender: Female
gender based: Yes
gender description: the patients undergoing the gynecological laparoscopic surgery
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Youngeun Moon, MD
role: Principal Investigator
affiliation: Seoul St. Mary's Hospital
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: The Catholic University of Korea
investigator full name: Young Eun Moon
investigator title: associate professor
mesh term: Genital Diseases, Female
mesh term: Lidocaine
mesh term: Dexmedetomidine
mesh term: Remifentanil
sharing ipd: No