<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/NCT02194855</url>
  </required_header>
  <id_info>
    <org_study_id>TingtingWang</org_study_id>
    <nct_id>NCT02194855</nct_id>
  </id_info>
  <brief_title>Effect of Laparoscopic Operation on Rocuronium and Cisatracurium: Pharmacokinetic and Pharmacodynamic Analysis</brief_title>
  <official_title>Effect of Laparoscopic Operation on Rocuronium and Cisatracurium: Pharmacokinetic and Pharmacodynamic Analysis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators investigated whether laparoscopic versus open surgical approaches affected&#xD;
      the pharmacokinetic and pharmacodynamic of a single bolus dose of rocuronium or&#xD;
      cisatracurium.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">June 1, 2016</completion_date>
  <primary_completion_date type="Actual">January 1, 2016</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the blood flow in the right and middle hepatic veins</measure>
    <time_frame>up to 9 months</time_frame>
    <description>Measurements of the blood flow in the right and middle hepatic veins were performed at baseline and 1,5, 10, 20, 30min after insufflation of carbon dioxide or incise the skin as well as 1 and 5 min after deflation or close the wound.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the plasma Concentration of rocuronium and cisatracurium</measure>
    <time_frame>up to 9 months</time_frame>
    <description>Venous blood samples (3 ml) were taken 2 min prior to and at 5,30, 60 min following administration of rocuronium/cisatracurium.The aim of the present was to study the blood concentration of rocuronium/cisatracurium in laparoscopic surgery compared with conventional open gynaecological surgery</description>
  </secondary_outcome>
  <other_outcome>
    <measure>pharmacodynamic comparison of rocuronium and cisatracurium</measure>
    <time_frame>up to 9 months</time_frame>
    <description>This study was undertaken to investigate the duration of action of 0.9 mg.kg-1 rocuronium or cisatracurium 0.15 mg.kg-1 administered during laparoscopic surgery compared with conventional open gynaecological surgery.Adductor pollicis train-of-four responses following ulnar nerve stimulation were monitored with mechanomyography.We recorded the time from the end of injection of rocuronium or cisatracurium to time to recovery of T1, and to recovery to 5% and 25% of baseline height</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>C.Delivery; Surgery (Previous), Gynecological</condition>
  <arm_group>
    <arm_group_label>laparoscopic operation on rocuronium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>laparoscopic operation on cisatracurium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional open surgery on rocuronium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional open surgery on cisatracurium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rocuronium</intervention_name>
    <description>Rocuronium 0.6 mg.kg-1 was administered within 5 s as an intravenous bolus</description>
    <arm_group_label>conventional open surgery on rocuronium</arm_group_label>
    <arm_group_label>laparoscopic operation on rocuronium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cisatracurium</intervention_name>
    <description>cisatracurium 0.15mg.kg-1 was administered within 5 s as an intravenous bolus</description>
    <arm_group_label>conventional open surgery on cisatracurium</arm_group_label>
    <arm_group_label>laparoscopic operation on cisatracurium</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiology 1-2&#xD;
&#xD;
          -  BMI 18-30 kg.m-2&#xD;
&#xD;
          -  elective gynaecological operations under general anaesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cirrhosis&#xD;
&#xD;
          -  hepatitis&#xD;
&#xD;
          -  hepatoma&#xD;
&#xD;
          -  heart failure&#xD;
&#xD;
          -  arrhythmia&#xD;
&#xD;
          -  renal dysfunction&#xD;
&#xD;
          -  electrolyte disturbances&#xD;
&#xD;
          -  acid-base imbalances&#xD;
&#xD;
          -  neuromuscular disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shaoqiang Huang, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Obstetrics and Gynecology,Fudan University</affiliation>
  </overall_official>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>August 10, 2020</last_update_submitted>
  <last_update_submitted_qc>August 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Tingting Wang</investigator_full_name>
    <investigator_title>Tingting Wang</investigator_title>
  </responsible_party>
  <keyword>rocuronium</keyword>
  <keyword>cisatracurium</keyword>
  <keyword>pharmacokinetic</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rocuronium</mesh_term>
    <mesh_term>Cisatracurium</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/NCT02194855
org study id: TingtingWang
nct id: NCT02194855
lead sponsor: 
has dmc: Yes
The investigators investigated whether laparoscopic versus open surgical approaches affected
      the pharmacokinetic and pharmacodynamic of a single bolus dose of rocuronium or
      cisatracurium.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: the blood flow in the right and middle hepatic veins
time frame: up to 9 months
description: Measurements of the blood flow in the right and middle hepatic veins were performed at baseline and 1,5, 10, 20, 30min after insufflation of carbon dioxide or incise the skin as well as 1 and 5 min after deflation or close the wound.
measure: the plasma Concentration of rocuronium and cisatracurium
time frame: up to 9 months
description: Venous blood samples (3 ml) were taken 2 min prior to and at 5,30, 60 min following administration of rocuronium/cisatracurium.The aim of the present was to study the blood concentration of rocuronium/cisatracurium in laparoscopic surgery compared with conventional open gynaecological surgery
measure: pharmacodynamic comparison of rocuronium and cisatracurium
time frame: up to 9 months
description: This study was undertaken to investigate the duration of action of 0.9 mg.kg-1 rocuronium or cisatracurium 0.15 mg.kg-1 administered during laparoscopic surgery compared with conventional open gynaecological surgery.Adductor pollicis train-of-four responses following ulnar nerve stimulation were monitored with mechanomyography.We recorded the time from the end of injection of rocuronium or cisatracurium to time to recovery of T1, and to recovery to 5% and 25% of baseline height
arm group label: laparoscopic operation on rocuronium
arm group type: Experimental
description: according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group.
arm group label: laparoscopic operation on cisatracurium
arm group type: Experimental
description: according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group.
arm group label: conventional open surgery on rocuronium
arm group type: Experimental
description: according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group.
arm group label: conventional open surgery on cisatracurium
arm group type: Experimental
description: according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group.
intervention type: Drug
intervention name: rocuronium
description: Rocuronium 0.6 mg.kg-1 was administered within 5 s as an intravenous bolus
arm group label: conventional open surgery on rocuronium
arm group label: laparoscopic operation on rocuronium
intervention type: Drug
intervention name: cisatracurium
description: cisatracurium 0.15mg.kg-1 was administered within 5 s as an intravenous bolus
arm group label: conventional open surgery on cisatracurium
arm group label: laparoscopic operation on cisatracurium
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Shaoqiang Huang, doctor
role: Principal Investigator
affiliation: Obstetrics and Gynecology,Fudan University
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Tingting Wang
investigator title: Tingting Wang
mesh term: Rocuronium
mesh term: Cisatracurium