<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/NCT02222519</url>
  </required_header>
  <id_info>
    <org_study_id>2014071801</org_study_id>
    <nct_id>NCT02222519</nct_id>
  </id_info>
  <brief_title>Interaction of Statins and Nondepolarizing Muscle Relaxants</brief_title>
  <official_title>Interaction of Statins and Nondepolarizing Muscle Relaxants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huang-wei LV</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Hospital of China Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      provide evidence for prevention or reduction muscle pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine interaction of statins and nondepolarizing muscle&#xD;
      relaxant,In order to provide evidence for prevention or reduction muscle pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>plasma myoglobin concentration</measure>
    <time_frame>20 minutes after administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>muscle pain</measure>
    <time_frame>2 and 24 hours postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum potassium concentration</measure>
    <time_frame>2 and 24 hours postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plasma creatine phosphokinase concentration</measure>
    <time_frame>2 and 24 hours postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>urine myoglobin and onset plus duration of succinylcholine block</measure>
    <time_frame>2 and 24 hours postoperatively</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Statin use group</arm_group_label>
    <description>patients taking statins for at least 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non statin use</arm_group_label>
    <description>no history of taking statin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rocuronium</intervention_name>
    <description>Rocuronium 0.6mg/kg iv single dose</description>
    <arm_group_label>Statin use group</arm_group_label>
    <arm_group_label>non statin use</arm_group_label>
    <other_name>Rocuronium Bromide Injection</other_name>
    <other_name>Esmeron</other_name>
    <other_name>http://www.msdchina.com.cn/</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three&#xD;
        months.&#xD;
&#xD;
        Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least&#xD;
        three months&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with American Society of Anesthesiologists physical status I-III&#xD;
&#xD;
          -  Patients taking statins for at least 3 months and those who had never used statins&#xD;
             were considered to be eligible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Orthopedic&#xD;
&#xD;
          -  Spinal surgery&#xD;
&#xD;
          -  Surgery involving extensive muscle manipulation&#xD;
&#xD;
          -  History of liver and kidney failure&#xD;
&#xD;
          -  Neuromuscular disease&#xD;
&#xD;
          -  Susceptibility to or family history of malignant hyperthermia&#xD;
&#xD;
          -  Extensive denervation of skeletal muscle&#xD;
&#xD;
          -  Chronic pain syndromes&#xD;
&#xD;
          -  Taking medications that might interact with the effect of rocuronium or serum&#xD;
             myoglobin difficult intubation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huangwei Lv, Professor</last_name>
    <role>Study Director</role>
    <affiliation>the Anesthesiology Department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huang-wei Lv, Professor</last_name>
      <phone>86-024-83283100</phone>
      <email>hwl1998@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Huang-wei LV, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>October 22, 2014</last_update_submitted>
  <last_update_submitted_qc>October 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>First Hospital of China Medical University</investigator_affiliation>
    <investigator_full_name>Huang-wei LV</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>statins</keyword>
  <keyword>nondepolarizing muscle relaxants</keyword>
  <keyword>rocuronium</keyword>
  <keyword>myalgia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Hypotonia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bromides</mesh_term>
    <mesh_term>Rocuronium</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/NCT02222519
org study id: 2014071801
nct id: NCT02222519
lead sponsor: 
has dmc: Yes
provide evidence for prevention or reduction muscle pain.
The purpose of this study is to determine interaction of statins and nondepolarizing muscle
      relaxant,In order to provide evidence for prevention or reduction muscle pain.
observational model: Case-Control
time perspective: Prospective
measure: plasma myoglobin concentration
time frame: 20 minutes after administration
measure: muscle pain
time frame: 2 and 24 hours postoperatively
measure: serum potassium concentration
time frame: 2 and 24 hours postoperatively
measure: plasma creatine phosphokinase concentration
time frame: 2 and 24 hours postoperatively
measure: urine myoglobin and onset plus duration of succinylcholine block
time frame: 2 and 24 hours postoperatively
arm group label: Statin use group
description: patients taking statins for at least 3 months
arm group label: non statin use
description: no history of taking statin
intervention type: Drug
intervention name: Rocuronium
description: Rocuronium 0.6mg/kg iv single dose
arm group label: Statin use group
arm group label: non statin use
other name: Rocuronium Bromide Injection
other name: Esmeron
other name: http://www.msdchina.com.cn/
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Huangwei Lv, Professor
role: Study Director
affiliation: the Anesthesiology Department
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: First Hospital of China Medical University
investigator full name: Huang-wei LV
investigator title: Professor
mesh term: Muscle Hypotonia
mesh term: Bromides
mesh term: Rocuronium