<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/NCT03788018</url>
  </required_header>
  <id_info>
    <org_study_id>AnqingMH</org_study_id>
    <nct_id>NCT03788018</nct_id>
  </id_info>
  <brief_title>Effect of Lidocaine Plus Dexmedetomidine Infusion on PONV</brief_title>
  <official_title>Effect of Intravenous Lidocaine Combined With Dexmedetomidine on Postoperative Nausea and Vomiting After Laparoscopic Hysterectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xu Siqi</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>
    <is_us_export>No</is_us_export>
  </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: One hundred and twenty women with elective laparoscopic hysterectomy were randomly&#xD;
      divided into two groups: patients in the lidocaine combined with dexmedetomidine group (LD&#xD;
      group, n=60) received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine&#xD;
      (0.5 μg/kg loading, 0.4 μg/kg/h infusion) respectively. Patients in the control group (CON&#xD;
      group, n=60) received the equal volume of saline. Primary outcome was the incidence of the&#xD;
      first 48 h nausea, vomiting and PONV after surgery. The secondary outcomes included&#xD;
      perioperative propofol and remifentanil consumption, postoperative fentanyl requirement,&#xD;
      Ramsay sedation score, and bradycardia during post-anaesthesia care unit (PACU) stay.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">November 15, 2018</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>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Lidocaine</condition>
  <condition>Dexmedetomidine</condition>
  <condition>Nausea and Vomiting, Postoperative</condition>
  <arm_group>
    <arm_group_label>Effect of IV lidocaine and dexmedetomidine on PONV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Effect of IV saline 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 IV</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>Effect of IV lidocaine and dexmedetomidine on PONV</arm_group_label>
    <arm_group_label>Effect of IV saline on PONV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>saline IV</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>Effect of IV lidocaine and dexmedetomidine on PONV</arm_group_label>
    <arm_group_label>Effect of IV saline on PONV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ&#xD;
&#xD;
          -  Aged 40-55 years&#xD;
&#xD;
          -  Scheduled for elective laparoscopic hysterectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of allergy to local anesthetics&#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>55 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>January 2019</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Anqing Municipal Hospital</investigator_affiliation>
    <investigator_full_name>Xu Siqi</investigator_full_name>
    <investigator_title>Department of Anesthesiology</investigator_title>
  </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>
  <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/NCT03788018
org study id: AnqingMH
nct id: NCT03788018
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: 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: One hundred and twenty women with elective laparoscopic hysterectomy were randomly
      divided into two groups: patients in the lidocaine combined with dexmedetomidine group (LD
      group, n=60) received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine
      (0.5 μg/kg loading, 0.4 μg/kg/h infusion) respectively. Patients in the control group (CON
      group, n=60) received the equal volume of saline. 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: Effect of IV lidocaine and dexmedetomidine on PONV
arm group type: Experimental
arm group label: Effect of IV saline on PONV
arm group type: Experimental
intervention type: Drug
intervention name: lidocaine and dexmedetomidine IV
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: Effect of IV lidocaine and dexmedetomidine on PONV
arm group label: Effect of IV saline on PONV
intervention type: Drug
intervention name: saline IV
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: Effect of IV lidocaine and dexmedetomidine on PONV
arm group label: Effect of IV saline on PONV
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Anqing Municipal Hospital
investigator full name: Xu Siqi
investigator title: Department of Anesthesiology
mesh term: Nausea
mesh term: Vomiting
mesh term: Postoperative Nausea and Vomiting
mesh term: Lidocaine
mesh term: Dexmedetomidine
sharing ipd: No