<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/NCT02224170</url>
  </required_header>
  <id_info>
    <org_study_id>4-2014-0530</org_study_id>
    <nct_id>NCT02224170</nct_id>
  </id_info>
  <brief_title>Comparison of Effect on Quality of Recovery Outcome Between Systemic Lidocaine and Dexamethasone in Patients Undergoing Laparoscopic Cholecystectomy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to compare the effect of lidocaine and dexamethasone on&#xD;
      postoperative quality of recovery after laparoscopic cholecystectomy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to difficulties in recruiting the subjects.&#xD;
  </why_stopped>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>QoR-40 score</measure>
    <time_frame>from baseline to 3 hours on the day after surgery</time_frame>
    <description>40-item quality-of-recovery scoring system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence and severity of postoperative nausea and vomiting</measure>
    <time_frame>from baseline to 3 hours on the day after surgery</time_frame>
    <description>10 cm-visual analogue scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Time to first analgesic request</measure>
    <time_frame>from baseline to 3 hours on the day after surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of rescue pain reliever</measure>
    <time_frame>from baseline to 3 hours on the day after surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Severity of postoperative pain</measure>
    <time_frame>from baseline to 3 hours on the day after surgery</time_frame>
    <description>10 cm-visual analogue scale</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Gallbladder Polyp</condition>
  <condition>Asymptomatic Gallstones Without Cholecystitis</condition>
  <arm_group>
    <arm_group_label>Lidocaine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexamethasone group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>Lidocaine 2mg Kg-1 in normal saline (total volume 25mL) was infused after tracheal intubation, and lidocaine was infused at the rate of lidocaine 2mg Kg-1 h-1 (0.2 ml Kg-1 h-1, equivalent volume as normal saline in dexamethasone group) until the end of surgery (at the time of skin closure).</description>
    <arm_group_label>Lidocaine group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Dexamethasone 8mg in normal saline (total volume 25mL) was infused after tracheal intubation, and normal saline was continuously infused at the rate of 0.2 ml Kg-1 h-1 until the end of surgery (at the time of skin closure).</description>
    <arm_group_label>Dexamethasone group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-II patients aged between 20 and 65 year undergoing laparoscopic cholecystectomy&#xD;
             due to gallbladder polyp or asymptomatic gallstones without cholecystitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Steroid therapy or immunocompromised patients&#xD;
&#xD;
          2. Diabetes mellitus&#xD;
&#xD;
          3. Allergy to lidocaine or dexamethasone&#xD;
&#xD;
          4. Severe renal dysfunction (serum creatinine more than 1.6mg/dl)&#xD;
&#xD;
          5. Severe liver disease ( liver enzymes more than two times normal values)&#xD;
&#xD;
          6. History of atrioventricular block&#xD;
&#xD;
          7. Have a difficulty in understanding QoR-40 (40-item quality-of-recovery scoring system)&#xD;
             or Korean language&#xD;
&#xD;
          8. History of physicologic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Surgery, Yonsei University College of Medicine, Seoul, Korea</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>March 15, 2019</last_update_submitted>
  <last_update_submitted_qc>March 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dexamethasone</keyword>
  <keyword>Lidocaine</keyword>
  <keyword>Quality of Recovery</keyword>
  <keyword>Laparoscopic cholecystectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecystitis</mesh_term>
    <mesh_term>Gallstones</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Lidocaine</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/NCT02224170
org study id: 4-2014-0530
nct id: NCT02224170
lead sponsor: 
has dmc: No
The primary purpose of this study is to compare the effect of lidocaine and dexamethasone on
      postoperative quality of recovery after laparoscopic cholecystectomy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: QoR-40 score
time frame: from baseline to 3 hours on the day after surgery
description: 40-item quality-of-recovery scoring system
measure: Incidence and severity of postoperative nausea and vomiting
time frame: from baseline to 3 hours on the day after surgery
description: 10 cm-visual analogue scale
measure: Time to first analgesic request
time frame: from baseline to 3 hours on the day after surgery
measure: Number of rescue pain reliever
time frame: from baseline to 3 hours on the day after surgery
measure: Severity of postoperative pain
time frame: from baseline to 3 hours on the day after surgery
description: 10 cm-visual analogue scale
arm group label: Lidocaine group
arm group type: Experimental
arm group label: Dexamethasone group
arm group type: Active Comparator
intervention type: Drug
intervention name: Lidocaine
description: Lidocaine 2mg Kg-1 in normal saline (total volume 25mL) was infused after tracheal intubation, and lidocaine was infused at the rate of lidocaine 2mg Kg-1 h-1 (0.2 ml Kg-1 h-1, equivalent volume as normal saline in dexamethasone group) until the end of surgery (at the time of skin closure).
arm group label: Lidocaine group
intervention type: Drug
intervention name: Dexamethasone
description: Dexamethasone 8mg in normal saline (total volume 25mL) was infused after tracheal intubation, and normal saline was continuously infused at the rate of 0.2 ml Kg-1 h-1 until the end of surgery (at the time of skin closure).
arm group label: Dexamethasone group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Cholecystitis
mesh term: Gallstones
mesh term: Dexamethasone
mesh term: Lidocaine