<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/NCT03276533</url>
  </required_header>
  <id_info>
    <org_study_id>xuzhang2013</org_study_id>
    <nct_id>NCT03276533</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine Combined With Lidocaine Infusion Affect Inflammation Cytokines</brief_title>
  <official_title>Effects of Intravenous Dexmedetomidine, Lidocaine and Their Combination on Postoperative Inflammation Cytokines After Laparoscopic Hysterectomy With General Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anqing Municipal Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The First Affiliated Hospital of Anhui Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      Objective: The present study was to evaluate the effects of dexmedetomidine alone, lidocaine&#xD;
      alone and their combined infusion on postoperative inflammation cytokines after Laparoscopic&#xD;
      hysterectomy.&#xD;
&#xD;
      Methods: Investigators enrolled 160 women with American Society of Anesthesiologists (ASA)&#xD;
      physical status I and II, aged 40-65 years, and scheduled for elective laparoscopic&#xD;
      hysterectomy with general anesthesia from October 2017 to August 2018. The participants were&#xD;
      randomly assigned into four groups(n=40 each group): group CON received normal saline&#xD;
      infusion, group LIDO received lidocaine infusion (1.5 mg/kg loading, 1.5 mg/kg/h infusion),&#xD;
      group DEX received dexmedetomidine infusion (0.5 µg/kg loading, 0.4 µg/kg/h infusion) and&#xD;
      group LIDO+DEX received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and&#xD;
      dexmedetomidine infusions (0.5 µg/kg loading, 0.4 µg/kg/h infusion). The four groups received&#xD;
      an IV bolus infusion of normal saline, lidocaine, dexmedetomidine and lidocaine combined with&#xD;
      dexmedetomidine respectively, over 10 minutes before induction of anesthesia, followed by a&#xD;
      continuous IV infusion of normal saline, lidocaine, dexmedetomidine and lidocaine combined&#xD;
      with dexmedetomidine until abdominal wound closure, respectively. Interleukin-6 and tumor&#xD;
      necrosis factor-α levels in serum were measured at different time points: before&#xD;
      administration of drugs (T1), the end of surgery (T2), postoperative 2 hour (T3) and&#xD;
      postoperative 24 hour (T4).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">August 10, 2020</completion_date>
  <primary_completion_date type="Actual">August 6, 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>Interleukin-6</measure>
    <time_frame>postoperative 24 hours</time_frame>
    <description>Interleukin-6 level in serum was measured at the before administration of drugs (T1), Interleukin-6 level in serum was measured at the end of the operation (T2); Interleukin-6 level in serum was measured at the postoperative 2 hour (T3); Interleukin-6 level in serum was measured at the postoperative 24 hour (T4)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor necrosis factor-α</measure>
    <time_frame>postoperative 24 hours</time_frame>
    <description>Tumor necrosis factor-α level in serum was measured at the before administration of drugs (T1); Tumor necrosis factor-α level in serum was measured at the end of the operation (T2); Tumor necrosis factor-α level in serum was measured at the postoperative 2 hour (T3); Tumor necrosis factor-α level in serum was measured at the postoperative 24 hour (T4)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interleukin-1</measure>
    <time_frame>postoperative 24 hours</time_frame>
    <description>Interleukin-1 level in serum was measured at the before administration of drugs (T1); Interleukin-1 level in serum was measured at the end of the operation (T2); Interleukin-1 level in serum was measured at the postoperative 2 hour (T3); Interleukin-1 level in serum was measured at the postoperative 24 hour (T4)</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Anesthesia; Reaction</condition>
  <arm_group>
    <arm_group_label>Intravenous saline, dexmedetomidine and lidocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous saline, dexmedetomidine, lidocaine and combination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous saline,dexmedetomidine plus lidocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous saline, dexmedetomidine combined with lidocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Participants in the group CON were received normal saline infusion until 30 min before the end of the operation.Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)</description>
    <arm_group_label>Intravenous saline, dexmedetomidine and lidocaine</arm_group_label>
    <arm_group_label>Intravenous saline, dexmedetomidine combined with lidocaine</arm_group_label>
    <arm_group_label>Intravenous saline, dexmedetomidine, lidocaine and combination</arm_group_label>
    <arm_group_label>Intravenous saline,dexmedetomidine plus lidocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>Participants in the group LIDO received lidocaine infusion (1.5 mg/kg loading, 1.5 mg/kg/h infusion)until 30 min before the end of the operation.Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)</description>
    <arm_group_label>Intravenous saline, dexmedetomidine and lidocaine</arm_group_label>
    <arm_group_label>Intravenous saline, dexmedetomidine combined with lidocaine</arm_group_label>
    <arm_group_label>Intravenous saline, dexmedetomidine, lidocaine and combination</arm_group_label>
    <arm_group_label>Intravenous saline,dexmedetomidine plus lidocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Participants in the group DEX received dexmedetomidine infusion (0.5 µg/kg loading, 0.4 µg/kg/h infusion) until 30 min before the end of the operation. Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)</description>
    <arm_group_label>Intravenous saline, dexmedetomidine and lidocaine</arm_group_label>
    <arm_group_label>Intravenous saline, dexmedetomidine combined with lidocaine</arm_group_label>
    <arm_group_label>Intravenous saline, dexmedetomidine, lidocaine and combination</arm_group_label>
    <arm_group_label>Intravenous saline,dexmedetomidine plus lidocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine plus Dexmedetomidine</intervention_name>
    <description>Participants in the group LIDO+DEX were received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine infusion (0.5 μg/kg loading, 0.4 μg/kg/h infusion) until 30 min before the end of the operation, respectively. Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)</description>
    <arm_group_label>Intravenous saline, dexmedetomidine and lidocaine</arm_group_label>
    <arm_group_label>Intravenous saline, dexmedetomidine combined with lidocaine</arm_group_label>
    <arm_group_label>Intravenous saline, dexmedetomidine, lidocaine and combination</arm_group_label>
    <arm_group_label>Intravenous saline,dexmedetomidine plus lidocaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status I and II&#xD;
&#xD;
          -  weighted 50 kg-65 kg&#xD;
&#xD;
          -  aged 40-65 yr&#xD;
&#xD;
          -  elective laparoscopic hysterectomy with general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a history of allergy to local anesthetics&#xD;
&#xD;
          -  severe respiratory, renal or hepatic disease&#xD;
&#xD;
          -  preoperative opioids medication&#xD;
&#xD;
          -  psychiatric medical history&#xD;
&#xD;
          -  Patients with severe hypotension [mean arterial pressure (MAP&lt;60 mmHg)] or bradycardia&#xD;
             [heart rate (HR) &lt;40 beats per minute (bpm)], arrhythmia, or urticaria due to&#xD;
             lidocaine and dexmedetomidine infusion during the surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wang shenbing</last_name>
    <role>Study Director</role>
    <affiliation>Department of Anqing Hospital Anesthesiology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiao jingbo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anqing Hospital Anesthesiology</affiliation>
  </overall_official>
  <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>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>March 8, 2022</last_update_submitted>
  <last_update_submitted_qc>March 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Anqing Municipal Hospital</investigator_affiliation>
    <investigator_full_name>Xu Siqi</investigator_full_name>
    <investigator_title>Principal Investigator,Department of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>dexmedetomidine; lidocaine; cytokine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</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/NCT03276533
org study id: xuzhang2013
nct id: NCT03276533
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objective: The present study was to evaluate the effects of dexmedetomidine alone, lidocaine
      alone and their combined infusion on postoperative inflammation cytokines after Laparoscopic
      hysterectomy.

      Methods: Investigators enrolled 160 women with American Society of Anesthesiologists (ASA)
      physical status I and II, aged 40-65 years, and scheduled for elective laparoscopic
      hysterectomy with general anesthesia from October 2017 to August 2018. The participants were
      randomly assigned into four groups(n=40 each group): group CON received normal saline
      infusion, group LIDO received lidocaine infusion (1.5 mg/kg loading, 1.5 mg/kg/h infusion),
      group DEX received dexmedetomidine infusion (0.5 µg/kg loading, 0.4 µg/kg/h infusion) and
      group LIDO+DEX received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and
      dexmedetomidine infusions (0.5 µg/kg loading, 0.4 µg/kg/h infusion). The four groups received
      an IV bolus infusion of normal saline, lidocaine, dexmedetomidine and lidocaine combined with
      dexmedetomidine respectively, over 10 minutes before induction of anesthesia, followed by a
      continuous IV infusion of normal saline, lidocaine, dexmedetomidine and lidocaine combined
      with dexmedetomidine until abdominal wound closure, respectively. Interleukin-6 and tumor
      necrosis factor-α levels in serum were measured at different time points: before
      administration of drugs (T1), the end of surgery (T2), postoperative 2 hour (T3) and
      postoperative 24 hour (T4).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Interleukin-6
time frame: postoperative 24 hours
description: Interleukin-6 level in serum was measured at the before administration of drugs (T1), Interleukin-6 level in serum was measured at the end of the operation (T2); Interleukin-6 level in serum was measured at the postoperative 2 hour (T3); Interleukin-6 level in serum was measured at the postoperative 24 hour (T4)
measure: Tumor necrosis factor-α
time frame: postoperative 24 hours
description: Tumor necrosis factor-α level in serum was measured at the before administration of drugs (T1); Tumor necrosis factor-α level in serum was measured at the end of the operation (T2); Tumor necrosis factor-α level in serum was measured at the postoperative 2 hour (T3); Tumor necrosis factor-α level in serum was measured at the postoperative 24 hour (T4)
measure: Interleukin-1
time frame: postoperative 24 hours
description: Interleukin-1 level in serum was measured at the before administration of drugs (T1); Interleukin-1 level in serum was measured at the end of the operation (T2); Interleukin-1 level in serum was measured at the postoperative 2 hour (T3); Interleukin-1 level in serum was measured at the postoperative 24 hour (T4)
arm group label: Intravenous saline, dexmedetomidine and lidocaine
arm group type: Experimental
arm group label: Intravenous saline, dexmedetomidine, lidocaine and combination
arm group type: Experimental
arm group label: Intravenous saline,dexmedetomidine plus lidocaine
arm group type: Experimental
arm group label: Intravenous saline, dexmedetomidine combined with lidocaine
arm group type: Experimental
intervention type: Drug
intervention name: Saline
description: Participants in the group CON were received normal saline infusion until 30 min before the end of the operation.Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)
arm group label: Intravenous saline, dexmedetomidine and lidocaine
arm group label: Intravenous saline, dexmedetomidine combined with lidocaine
arm group label: Intravenous saline, dexmedetomidine, lidocaine and combination
arm group label: Intravenous saline,dexmedetomidine plus lidocaine
intervention type: Drug
intervention name: Lidocaine
description: Participants in the group LIDO received lidocaine infusion (1.5 mg/kg loading, 1.5 mg/kg/h infusion)until 30 min before the end of the operation.Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)
arm group label: Intravenous saline, dexmedetomidine and lidocaine
arm group label: Intravenous saline, dexmedetomidine combined with lidocaine
arm group label: Intravenous saline, dexmedetomidine, lidocaine and combination
arm group label: Intravenous saline,dexmedetomidine plus lidocaine
intervention type: Drug
intervention name: Dexmedetomidine
description: Participants in the group DEX received dexmedetomidine infusion (0.5 µg/kg loading, 0.4 µg/kg/h infusion) until 30 min before the end of the operation. Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)
arm group label: Intravenous saline, dexmedetomidine and lidocaine
arm group label: Intravenous saline, dexmedetomidine combined with lidocaine
arm group label: Intravenous saline, dexmedetomidine, lidocaine and combination
arm group label: Intravenous saline,dexmedetomidine plus lidocaine
intervention type: Drug
intervention name: Lidocaine plus Dexmedetomidine
description: Participants in the group LIDO+DEX were received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine infusion (0.5 μg/kg loading, 0.4 μg/kg/h infusion) until 30 min before the end of the operation, respectively. Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)
arm group label: Intravenous saline, dexmedetomidine and lidocaine
arm group label: Intravenous saline, dexmedetomidine combined with lidocaine
arm group label: Intravenous saline, dexmedetomidine, lidocaine and combination
arm group label: Intravenous saline,dexmedetomidine plus lidocaine
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wang shenbing
role: Study Director
affiliation: Department of Anqing Hospital Anesthesiology
last name: Xiao jingbo
role: Principal Investigator
affiliation: Department of Anqing Hospital Anesthesiology
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Anqing Municipal Hospital
investigator full name: Xu Siqi
investigator title: Principal Investigator,Department of Anesthesiology
mesh term: Inflammation
mesh term: Lidocaine
mesh term: Dexmedetomidine
sharing ipd: No