<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/NCT02189655</url>
  </required_header>
  <id_info>
    <org_study_id>20140630</org_study_id>
    <nct_id>NCT02189655</nct_id>
  </id_info>
  <brief_title>Diluting With Cerebrospinal Fluid Versus Traditional Intrathecal Administration: Antishivering Effects</brief_title>
  <official_title>Diluting With Cerebrospinal Fluid Versus Traditional Intrathecal Administration: Antishivering Effects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective randomized double-blinded study was conducted to compare the antishivering&#xD;
      effects of two different types of intrathecal administration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective randomized double-blinded study was conducted to compare the antishivering&#xD;
      effects of two different types of intrathecal administration.Group Control:traditional&#xD;
      intrathecal administration; Group Diluting:Diluting with cerebrospinal fluid&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>antishivering effects of two different types of spinal anesthesia</measure>
    <time_frame>time point 1: 15 minuntes after spinal anesthesia and time point 2 : when patiets were sent to postoperation care unit</time_frame>
    <description>antishivering effects of two different types administration of spinal anesthesia</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Antishivering Effects</condition>
  <arm_group>
    <arm_group_label>Group Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Hyperbaric bupivacaine 0.5% 2.5 mL was administered intrathecally in 30 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Diluting with cerebrospinal fluid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hyperbaric bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid was administered intrathecally in 30 seconds</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid</intervention_name>
    <description>Hyperbaric bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid was administered intrathecally in 30 seconds</description>
    <arm_group_label>Group Diluting with cerebrospinal fluid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status Ⅰ or Ⅱ who were scheduled&#xD;
             for elective surgery under spinal anesthesia were enrolled.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with pre-operative fever (&gt;38℃), diabetes, , Parkinson's disease, hypo or&#xD;
             hyperthyroidism, Raynaud's syndrome, obese patients (weight &gt;100 kg), patients shorter&#xD;
             than 152 cm, those with a history of allergy to the study medications, and patients&#xD;
             receiving vasodilators were excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong Ma, M.D.,Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>The First Hospital of CMU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>the First Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>June 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>November 18, 2019</last_update_submitted>
  <last_update_submitted_qc>November 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China Medical University, China</investigator_affiliation>
    <investigator_full_name>Wen-fei Tan</investigator_full_name>
    <investigator_title>Department of Anesthesiology, The First Hospital of CMU</investigator_title>
  </responsible_party>
  <keyword>shivering spinal anesthesia</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</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/NCT02189655
org study id: 20140630
nct id: NCT02189655
lead sponsor: 
has dmc: Yes
This prospective randomized double-blinded study was conducted to compare the antishivering
      effects of two different types of intrathecal administration.
This prospective randomized double-blinded study was conducted to compare the antishivering
      effects of two different types of intrathecal administration.Group Control:traditional
      intrathecal administration; Group Diluting:Diluting with cerebrospinal fluid
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: antishivering effects of two different types of spinal anesthesia
time frame: time point 1: 15 minuntes after spinal anesthesia and time point 2 : when patiets were sent to postoperation care unit
description: antishivering effects of two different types administration of spinal anesthesia
arm group label: Group Control
arm group type: No Intervention
description: Hyperbaric bupivacaine 0.5% 2.5 mL was administered intrathecally in 30 seconds.
arm group label: Group Diluting with cerebrospinal fluid
arm group type: Experimental
description: Hyperbaric bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid was administered intrathecally in 30 seconds
intervention type: Procedure
intervention name: bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid
description: Hyperbaric bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid was administered intrathecally in 30 seconds
arm group label: Group Diluting with cerebrospinal fluid
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hong Ma, M.D.,Ph.D
role: Study Director
affiliation: The First Hospital of CMU
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: China Medical University, China
investigator full name: Wen-fei Tan
investigator title: Department of Anesthesiology, The First Hospital of CMU
mesh term: Bupivacaine