<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/NCT03809923</url>
  </required_header>
  <id_info>
    <org_study_id>xuwen</org_study_id>
    <nct_id>NCT03809923</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine Combined With Lidocaine Infusion Affect PONV</brief_title>
  <official_title>Effects of Combination Intravenous Dexmedetomidine and Lidocaine on Postoperative Nausea and Vomiting After Laparoscopic Hysterectomy With General Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anqing Municipal Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Anqing Municipal 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>
      BACKGROUND: Few researches have manifested that intravenous (IV) lidocaine or dexmedetomidine&#xD;
      decreased the incidence of postoperative nausea and vomiting (PONV). The investigators&#xD;
      investigated whether IV lidocaine plus dexmedetomidine infusion could better reduce the&#xD;
      incidence of PONV after laparoscopic hysterectomy.&#xD;
&#xD;
      METHODS: Two hundred and forty women with elective laparoscopic hysterectomy were randomly&#xD;
      divided into four groups: the control group (group C, n=60) received an equal volume of&#xD;
      saline, the lidocaine group (group L, n=60) received IV lidocaine (bolus infusion of 1.5&#xD;
      mg/kg over 10 min, 1.5 mg/kg/h continuous infusion), the dexmedetomidine group (group D,&#xD;
      n=60) received dexmedetomidine administration (bolus infusion of 0.5 µg/kg over 10 min, 0.4&#xD;
      µg/kg/h continuous infusion), the lidocaine plus dexmedetomidine group (group LD, n=60)&#xD;
      received combination of lidocaine (bolus infusion of 1.5 mg/kg over 10 min, 1.5 mg/kg/h&#xD;
      continuous infusion) and dexmedetomidine administration (bolus infusion of 0.5 µg/kg over 10&#xD;
      min, 0.4 µg/kg/h continuous infusion). Primary outcome was the incidence of the first 48 h&#xD;
      nausea, vomiting and PONV after surgery. The secondary outcomes included perioperative&#xD;
      propofol and remifentanil consumption, postoperative fentanyl requirement, Ramsay sedation&#xD;
      score, and bradycardia during post-anaesthesia care unit (PACU) stay.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Actual">January 12, 2021</completion_date>
  <primary_completion_date type="Actual">August 1, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative nausea</measure>
    <time_frame>0-2 hours after surgery</time_frame>
    <description>Our primary outcome was the incidence of nausea during the 0-2 hours after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>postoperative nausea</measure>
    <time_frame>2-24 hours after surgery</time_frame>
    <description>Our primary outcome was the incidence of nausea during the 2-24 hours after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>postoperative nausea</measure>
    <time_frame>24-48 hours after surgery</time_frame>
    <description>Our primary outcome was the incidence of nausea during the 24-48 hours after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>postoperative vomiting</measure>
    <time_frame>0-2 hours after surgery</time_frame>
    <description>Our primary outcome was the incidence of vomiting during the 0-2 hours after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>postoperative vomiting</measure>
    <time_frame>2-24 hours after surgery</time_frame>
    <description>Our primary outcome was the incidence of vomiting during the 2-24 hours after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>postoperative vomiting</measure>
    <time_frame>24-48 hours after surgery</time_frame>
    <description>Our primary outcome was the incidence of vomiting during the 24-48 hours after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>postoperative nausea and vomiting (PONV)</measure>
    <time_frame>0-2 hours after surgery</time_frame>
    <description>Our primary outcome was the incidence of PONV during the 0-2 hours after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>postoperative nausea and vomiting (PONV)</measure>
    <time_frame>2-24 hours after surgery</time_frame>
    <description>Our primary outcome was the incidence of PONV during the 2-24 hours after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>postoperative nausea and vomiting (PONV)</measure>
    <time_frame>24-48 hours after surgery</time_frame>
    <description>Our primary outcome was the incidence of PONV during the 24-48 hours after surgery</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Lidocaine</condition>
  <condition>Dexmedetomidine</condition>
  <condition>Nausea and Vomiting, Postoperative</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine Combined With Lidocaine Infusion Affect PONV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Effect of infusion saline on PONV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Effect of infusion lidocaine on PONV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Effect of infusion dexmedetomidine on PONV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lidocaine and dexmedetomidine infusion</intervention_name>
    <description>Patients received IV bolus infusion of lidocaine (2%) 1.5 mg/kg and dexmedetomidine 0.5 µg/kg diluted with normal saline to 20 ml in the LD group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion at rate of lidocaine 1.5 mg/kg and dexmedetomidine 0.4 µg/kg made up to 20 mL every hour until 30 min before the end of operation, respectively.</description>
    <arm_group_label>Dexmedetomidine Combined With Lidocaine Infusion Affect PONV</arm_group_label>
    <arm_group_label>Effect of infusion dexmedetomidine on PONV</arm_group_label>
    <arm_group_label>Effect of infusion lidocaine on PONV</arm_group_label>
    <arm_group_label>Effect of infusion saline on PONV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline infusion</intervention_name>
    <description>Patients received 20 ml normal saline and 20 ml normal saline in the CON group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion 20 ml normal saline and 20 ml normal saline every hour until 30 min before the end of surgery</description>
    <arm_group_label>Dexmedetomidine Combined With Lidocaine Infusion Affect PONV</arm_group_label>
    <arm_group_label>Effect of infusion dexmedetomidine on PONV</arm_group_label>
    <arm_group_label>Effect of infusion lidocaine on PONV</arm_group_label>
    <arm_group_label>Effect of infusion saline on PONV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine infusion</intervention_name>
    <description>patients received an IV bolus infusion of lidocaine (2%) 1.5 mg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of lidocaine 1.5 mg/kg made up to 20ml and 20ml normal saline every hour until 30 min before the end of operation, respectively.</description>
    <arm_group_label>Dexmedetomidine Combined With Lidocaine Infusion Affect PONV</arm_group_label>
    <arm_group_label>Effect of infusion dexmedetomidine on PONV</arm_group_label>
    <arm_group_label>Effect of infusion lidocaine on PONV</arm_group_label>
    <arm_group_label>Effect of infusion saline on PONV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine infusion</intervention_name>
    <description>Patients received IV bolus infusion of dexmedetomidine 0.5 μg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of dexmedetomidine 0.4μg/kg made up to 20ml and 20ml normal saline every houruntil 30 min before the end of operation, respectively.</description>
    <arm_group_label>Dexmedetomidine Combined With Lidocaine Infusion Affect PONV</arm_group_label>
    <arm_group_label>Effect of infusion dexmedetomidine on PONV</arm_group_label>
    <arm_group_label>Effect of infusion lidocaine on PONV</arm_group_label>
    <arm_group_label>Effect of infusion saline on PONV</arm_group_label>
    <other_name>Dexmedetomidine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ&#xD;
&#xD;
          -  Aged 40-60 years&#xD;
&#xD;
          -  Scheduled for elective laparoscopic hysterectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of allergy to local anesthetics&#xD;
&#xD;
          -  BMI&gt;30&#xD;
&#xD;
          -  Severe respiratory disease&#xD;
&#xD;
          -  Renal or hepatic insufficiency&#xD;
&#xD;
          -  History of preoperative opioids medication and psychiatric&#xD;
&#xD;
          -  preoperative bradycardia&#xD;
&#xD;
          -  preoperative atrioventricular block&#xD;
&#xD;
          -  Subjects who experienced severe hypotension (mean arterial pressure [MAP] &lt;60 mmHg) or&#xD;
             bradycardia (heart rate [HR] &lt;40 bpm), urticaria, or arrhythmia during lidocaine and&#xD;
             dexmedetomidine infusion period&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anqing Hospital Anesthesiology</name>
      <address>
        <city>Anqing</city>
        <state>Anhui</state>
        <zip>246000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>March 10, 2022</last_update_submitted>
  <last_update_submitted_qc>March 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lidocaine</keyword>
  <keyword>Dexmedetomidine</keyword>
  <keyword>Postoperative nausea and vomiting</keyword>
  <keyword>laparoscopic hysterectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</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>
  </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/NCT03809923
org study id: xuwen
nct id: NCT03809923
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
BACKGROUND: Few researches have manifested that intravenous (IV) lidocaine or dexmedetomidine
      decreased the incidence of postoperative nausea and vomiting (PONV). The investigators
      investigated whether IV lidocaine plus dexmedetomidine infusion could better reduce the
      incidence of PONV after laparoscopic hysterectomy.

      METHODS: Two hundred and forty women with elective laparoscopic hysterectomy were randomly
      divided into four groups: the control group (group C, n=60) received an equal volume of
      saline, the lidocaine group (group L, n=60) received IV lidocaine (bolus infusion of 1.5
      mg/kg over 10 min, 1.5 mg/kg/h continuous infusion), the dexmedetomidine group (group D,
      n=60) received dexmedetomidine administration (bolus infusion of 0.5 µg/kg over 10 min, 0.4
      µg/kg/h continuous infusion), the lidocaine plus dexmedetomidine group (group LD, n=60)
      received combination of lidocaine (bolus infusion of 1.5 mg/kg over 10 min, 1.5 mg/kg/h
      continuous infusion) and dexmedetomidine administration (bolus infusion of 0.5 µg/kg over 10
      min, 0.4 µg/kg/h continuous infusion). Primary outcome was the incidence of the first 48 h
      nausea, vomiting and PONV after surgery. The secondary outcomes included perioperative
      propofol and remifentanil consumption, postoperative fentanyl requirement, Ramsay sedation
      score, and bradycardia during post-anaesthesia care unit (PACU) stay.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: postoperative nausea
time frame: 0-2 hours after surgery
description: Our primary outcome was the incidence of nausea during the 0-2 hours after surgery
measure: postoperative nausea
time frame: 2-24 hours after surgery
description: Our primary outcome was the incidence of nausea during the 2-24 hours after surgery
measure: postoperative nausea
time frame: 24-48 hours after surgery
description: Our primary outcome was the incidence of nausea during the 24-48 hours after surgery
measure: postoperative vomiting
time frame: 0-2 hours after surgery
description: Our primary outcome was the incidence of vomiting during the 0-2 hours after surgery
measure: postoperative vomiting
time frame: 2-24 hours after surgery
description: Our primary outcome was the incidence of vomiting during the 2-24 hours after surgery
measure: postoperative vomiting
time frame: 24-48 hours after surgery
description: Our primary outcome was the incidence of vomiting during the 24-48 hours after surgery
measure: postoperative nausea and vomiting (PONV)
time frame: 0-2 hours after surgery
description: Our primary outcome was the incidence of PONV during the 0-2 hours after surgery
measure: postoperative nausea and vomiting (PONV)
time frame: 2-24 hours after surgery
description: Our primary outcome was the incidence of PONV during the 2-24 hours after surgery
measure: postoperative nausea and vomiting (PONV)
time frame: 24-48 hours after surgery
description: Our primary outcome was the incidence of PONV during the 24-48 hours after surgery
arm group label: Dexmedetomidine Combined With Lidocaine Infusion Affect PONV
arm group type: Experimental
arm group label: Effect of infusion saline on PONV
arm group type: Experimental
arm group label: Effect of infusion lidocaine on PONV
arm group type: Experimental
arm group label: Effect of infusion dexmedetomidine on PONV
arm group type: Experimental
intervention type: Drug
intervention name: lidocaine and dexmedetomidine infusion
description: Patients received IV bolus infusion of lidocaine (2%) 1.5 mg/kg and dexmedetomidine 0.5 µg/kg diluted with normal saline to 20 ml in the LD group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion at rate of lidocaine 1.5 mg/kg and dexmedetomidine 0.4 µg/kg made up to 20 mL every hour until 30 min before the end of operation, respectively.
arm group label: Dexmedetomidine Combined With Lidocaine Infusion Affect PONV
arm group label: Effect of infusion dexmedetomidine on PONV
arm group label: Effect of infusion lidocaine on PONV
arm group label: Effect of infusion saline on PONV
intervention type: Drug
intervention name: Saline infusion
description: Patients received 20 ml normal saline and 20 ml normal saline in the CON group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion 20 ml normal saline and 20 ml normal saline every hour until 30 min before the end of surgery
arm group label: Dexmedetomidine Combined With Lidocaine Infusion Affect PONV
arm group label: Effect of infusion dexmedetomidine on PONV
arm group label: Effect of infusion lidocaine on PONV
arm group label: Effect of infusion saline on PONV
intervention type: Drug
intervention name: Lidocaine infusion
description: patients received an IV bolus infusion of lidocaine (2%) 1.5 mg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of lidocaine 1.5 mg/kg made up to 20ml and 20ml normal saline every hour until 30 min before the end of operation, respectively.
arm group label: Dexmedetomidine Combined With Lidocaine Infusion Affect PONV
arm group label: Effect of infusion dexmedetomidine on PONV
arm group label: Effect of infusion lidocaine on PONV
arm group label: Effect of infusion saline on PONV
intervention type: Drug
intervention name: Dexmedetomidine infusion
description: Patients received IV bolus infusion of dexmedetomidine 0.5 μg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of dexmedetomidine 0.4μg/kg made up to 20ml and 20ml normal saline every houruntil 30 min before the end of operation, respectively.
arm group label: Dexmedetomidine Combined With Lidocaine Infusion Affect PONV
arm group label: Effect of infusion dexmedetomidine on PONV
arm group label: Effect of infusion lidocaine on PONV
arm group label: Effect of infusion saline on PONV
other name: Dexmedetomidine
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
mesh term: Nausea
mesh term: Vomiting
mesh term: Postoperative Nausea and Vomiting
mesh term: Lidocaine
mesh term: Dexmedetomidine