<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/NCT04447105</url>
  </required_header>
  <id_info>
    <org_study_id>2003-177-1113</org_study_id>
    <nct_id>NCT04447105</nct_id>
  </id_info>
  <brief_title>Comparison of Postoperative Recovery Between TIVA and Inhalation Agent</brief_title>
  <official_title>Randomized Controlled Trial of the Effect of General Anesthetics on Postoperative Recovery After Minimally Invasive Nephrectomy (REGAIN 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>
      This prospective, randomized, single-blinded study is designed to compare the postoperative&#xD;
      quality of recovery between propofol based total intravenous anesthesia and desflurane in&#xD;
      patients undergoing minimally invasive nephrectomy. We hypothesize that propofol based total&#xD;
      intravenous anesthesia can significantly improve the quality of recovery after surgery in&#xD;
      patients with minimally invasive nephrectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adult patients undergoing elective laparoscopic or robotic assisted nephrectomy are randomly&#xD;
      allocated to receive propofol based total intravenous anesthesia (n=75) or desflurane (n=75).&#xD;
      The quality of recover after surgery using the QoR-15K was assessed by a investigator at&#xD;
      postoperative day (POD) 1, 2, and 3. The primary outcome is the QoR-15K at POD 1, 2, and 3&#xD;
      after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 28, 2020</start_date>
  <completion_date type="Actual">July 27, 2021</completion_date>
  <primary_completion_date type="Actual">July 5, 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>
    <intervention_model_description>A prospective randomized single-blinded study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Patients will receive general anesthesia, therefore they can not know their anesthetic method.&#xD;
Physicians involved in this study will investigate the outcomes.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>quality of recovery</measure>
    <time_frame>at 24 hours, 48 hours, 72 hours postoperatively</time_frame>
    <description>Change in the QoR-15K score from 24 hours to 72 hours postoperatively</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain score</measure>
    <time_frame>at 24 hours, 48 hours, 72 hours postoperatively</time_frame>
    <description>Change in the pain severity measured by the 11-pointed numeric rating scale (0: none/10: worst pain) pain score at resting/movement from 24 hours to 72 hours postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative nausea and vomiting during the first 24 hours postoperatively</measure>
    <time_frame>during the first 24 hours postoperatively</time_frame>
    <description>Incidence of postoperative nausea and vomiting (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative nausea and vomiting during the 24-48 hours postoperatively</measure>
    <time_frame>during the 24-48 hours postoperatively</time_frame>
    <description>Incidence of postoperative nausea and vomiting (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative nausea and vomiting during the 48-72 hours postoperatively</measure>
    <time_frame>during the 48-72 hours postoperatively</time_frame>
    <description>Incidence of postoperative nausea and vomiting (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total fentanyl consumption during the first 24 hours postoperatively</measure>
    <time_frame>during the first 24 hours postoperatively</time_frame>
    <description>Change in the postoperative fentanyl consumption (mcg) via IV patient controlled analgesia from 24 hours to 72 hours postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total fentanyl consumption during the 24-48 hours postoperatively</measure>
    <time_frame>during the 24-48 hours postoperatively</time_frame>
    <description>Change in the postoperative fentanyl consumption (mcg) via IV patient controlled analgesia from 24 hours to 72 hours postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total fentanyl consumption during the 48-72 hours postoperatively</measure>
    <time_frame>during the 48-72 hours postoperatively</time_frame>
    <description>Change in the postoperative fentanyl consumption (mcg) via IV patient controlled analgesia from 24 hours to 72 hours postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life at early post-discharge</measure>
    <time_frame>day before surgery and at 3 weeks after discharge</time_frame>
    <description>Change in the Quality of life measured using the EuroQoL 5-dimension 5-level scale (EQ-5D-5L) from baseline to early-postdischarge phase</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Enhanced Recovery After Surgery</condition>
  <arm_group>
    <arm_group_label>TIVA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving total intravenous anesthesia with propofol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Desflurane group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receiving inhalation anesthesia with desflurane.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>total intravenous anesthesia with propofol</intervention_name>
    <description>In the TIVA group, general anesthesia is induced and maintained with a target-controlled infusion of propofol using infusion pump (Orchestra®; Fresenius Vial, Brezins, France). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure.</description>
    <arm_group_label>TIVA group</arm_group_label>
    <other_name>TIVA group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>inhalation anesthesia with desflurane</intervention_name>
    <description>In the desflurane group, anesthesia is induced with propofol 1-2 mg/kg and maintained with desflurane (5-7 vol %). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure.</description>
    <arm_group_label>Desflurane group</arm_group_label>
    <other_name>DES group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled to undergo elective laparoscopic or robotic assisted nephrectomy&#xD;
             under general anesthesia&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical classification I-II&#xD;
&#xD;
          -  Willingness and ability to sign an informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Do not understand our study&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical classification III or more&#xD;
&#xD;
          -  Allergies to anesthetic or analgesic medications&#xD;
&#xD;
          -  Chronic pain, chronic analgesic or antidepressant or anticonvulsant use&#xD;
&#xD;
          -  Medical or psychological disease that can affect the treatment response&#xD;
&#xD;
          -  Patients who receive mechanical ventilation more than 2 hours after surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>KS013</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Lee WK, Kim MS, Kang SW, Kim S, Lee JR. Type of anaesthesia and patient quality of recovery: a randomized trial comparing propofol-remifentanil total i.v. anaesthesia with desflurane anaesthesia. Br J Anaesth. 2015 Apr;114(4):663-8. doi: 10.1093/bja/aeu405. Epub 2014 Dec 10.</citation>
    <PMID>25500679</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>August 2, 2021</last_update_submitted>
  <last_update_submitted_qc>August 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Hojin Lee, MD</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>quality of recovery after surgery</keyword>
  <keyword>anesthetic method</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Desflurane</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/NCT04447105
org study id: 2003-177-1113
nct id: NCT04447105
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This prospective, randomized, single-blinded study is designed to compare the postoperative
      quality of recovery between propofol based total intravenous anesthesia and desflurane in
      patients undergoing minimally invasive nephrectomy. We hypothesize that propofol based total
      intravenous anesthesia can significantly improve the quality of recovery after surgery in
      patients with minimally invasive nephrectomy.
Adult patients undergoing elective laparoscopic or robotic assisted nephrectomy are randomly
      allocated to receive propofol based total intravenous anesthesia (n=75) or desflurane (n=75).
      The quality of recover after surgery using the QoR-15K was assessed by a investigator at
      postoperative day (POD) 1, 2, and 3. The primary outcome is the QoR-15K at POD 1, 2, and 3
      after surgery.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A prospective randomized single-blinded study
primary purpose: Treatment
masking: Single (Participant)
masking description: Patients will receive general anesthesia, therefore they can not know their anesthetic method.
Physicians involved in this study will investigate the outcomes.
measure: quality of recovery
time frame: at 24 hours, 48 hours, 72 hours postoperatively
description: Change in the QoR-15K score from 24 hours to 72 hours postoperatively
measure: Postoperative pain score
time frame: at 24 hours, 48 hours, 72 hours postoperatively
description: Change in the pain severity measured by the 11-pointed numeric rating scale (0: none/10: worst pain) pain score at resting/movement from 24 hours to 72 hours postoperatively
measure: Postoperative nausea and vomiting during the first 24 hours postoperatively
time frame: during the first 24 hours postoperatively
description: Incidence of postoperative nausea and vomiting (%)
measure: Postoperative nausea and vomiting during the 24-48 hours postoperatively
time frame: during the 24-48 hours postoperatively
description: Incidence of postoperative nausea and vomiting (%)
measure: Postoperative nausea and vomiting during the 48-72 hours postoperatively
time frame: during the 48-72 hours postoperatively
description: Incidence of postoperative nausea and vomiting (%)
measure: Total fentanyl consumption during the first 24 hours postoperatively
time frame: during the first 24 hours postoperatively
description: Change in the postoperative fentanyl consumption (mcg) via IV patient controlled analgesia from 24 hours to 72 hours postoperatively
measure: Total fentanyl consumption during the 24-48 hours postoperatively
time frame: during the 24-48 hours postoperatively
description: Change in the postoperative fentanyl consumption (mcg) via IV patient controlled analgesia from 24 hours to 72 hours postoperatively
measure: Total fentanyl consumption during the 48-72 hours postoperatively
time frame: during the 48-72 hours postoperatively
description: Change in the postoperative fentanyl consumption (mcg) via IV patient controlled analgesia from 24 hours to 72 hours postoperatively
measure: Quality of life at early post-discharge
time frame: day before surgery and at 3 weeks after discharge
description: Change in the Quality of life measured using the EuroQoL 5-dimension 5-level scale (EQ-5D-5L) from baseline to early-postdischarge phase
arm group label: TIVA group
arm group type: Experimental
description: Patients receiving total intravenous anesthesia with propofol.
arm group label: Desflurane group
arm group type: Active Comparator
description: Patients receiving inhalation anesthesia with desflurane.
intervention type: Drug
intervention name: total intravenous anesthesia with propofol
description: In the TIVA group, general anesthesia is induced and maintained with a target-controlled infusion of propofol using infusion pump (Orchestra®; Fresenius Vial, Brezins, France). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure.
arm group label: TIVA group
other name: TIVA group
intervention type: Drug
intervention name: inhalation anesthesia with desflurane
description: In the desflurane group, anesthesia is induced with propofol 1-2 mg/kg and maintained with desflurane (5-7 vol %). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure.
arm group label: Desflurane group
other name: DES group
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
citation: Lee WK, Kim MS, Kang SW, Kim S, Lee JR. Type of anaesthesia and patient quality of recovery: a randomized trial comparing propofol-remifentanil total i.v. anaesthesia with desflurane anaesthesia. Br J Anaesth. 2015 Apr;114(4):663-8. doi: 10.1093/bja/aeu405. Epub 2014 Dec 10.
PMID: 25500679
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Hojin Lee, MD
investigator title: Assistant professor
mesh term: Anesthetics
mesh term: Propofol
mesh term: Desflurane
sharing ipd: No