<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/NCT01722955</url>
  </required_header>
  <id_info>
    <org_study_id>Prewarmed fluid</org_study_id>
    <nct_id>NCT01722955</nct_id>
  </id_info>
  <brief_title>Pre-warmed Intravenous Fluids and Monitored Anesthesia Care</brief_title>
  <official_title>Effect of Pre-warmed Intravenous Fluids on the Early Outcomes After Ambulatory Surgery Under Monitored Anesthesia Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to compare effect of pre-warmed intravenous fluids on the early&#xD;
      outcomes in ambulatory patients undergoing monitored anesthesia care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Monitored anesthesia care (MAC) has been increasing in fast track anesthesia for ambulatory&#xD;
      or outpatient surgery. MAC provides lower anesthetic agents than general anesthesia, however&#xD;
      it has been shown to result high anesthetic complication rate because of negligent&#xD;
      monitoring. Therefore, aim of this study is to investigate the effect of pre-warmed&#xD;
      intravenous fluids on the core body temperature and the early outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tympanic membrane temperature</measure>
    <time_frame>30min after anesthetic induction</time_frame>
    <description>Preoperative dehydration will be supplemented with 10ml/kg of lactate Ringer's solution at the beginning of the anesthetic induction. 30 min after anesthetic induction is nearly after administering the fixed volume.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative chilling and shivering</measure>
    <time_frame>on arrival at the postanesthetic care unit ( 1hour after the anesthetic induction)</time_frame>
    <description>Degree of chilling and shivering will be evaluated at the postanesthesia care unit after the surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Hypothermia</condition>
  <arm_group>
    <arm_group_label>Pre-warmed fluids</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pre-warmed fluids will be prepared for 8hous in 41℃ set hot cabinet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Room temperature fluids</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Room temperature fluids will be stored at ambient temperature.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pre-warmed fluids</intervention_name>
    <description>IV fluid will be stored at 41℃ set hot cabinet for 8hours</description>
    <arm_group_label>Pre-warmed fluids</arm_group_label>
    <other_name>Warming intravenous (IV) fluid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Room temperature fluids</intervention_name>
    <description>Room temperature fluid will be stored at ambient temperature</description>
    <arm_group_label>Room temperature fluids</arm_group_label>
    <other_name>No warming intravenous fluids</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20years to 70years old female patients undergoing urinary incontinence surgery under&#xD;
             monitored anesthesia care.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preoperative tympanic membrane temperature &gt;38 or &lt; 36&#xD;
&#xD;
          -  End stage heart failure or renal failure&#xD;
&#xD;
          -  Otitis media&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Myung Hee Kim, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung MC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsung medical center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Yokoyama K, Suzuki M, Shimada Y, Matsushima T, Bito H, Sakamoto A. Effect of administration of pre-warmed intravenous fluids on the frequency of hypothermia following spinal anesthesia for Cesarean delivery. J Clin Anesth. 2009 Jun;21(4):242-8. doi: 10.1016/j.jclinane.2008.12.010. Epub 2009 Jun 6.</citation>
    <PMID>19502035</PMID>
  </results_reference>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>November 4, 2012</study_first_submitted>
  <study_first_submitted_qc>November 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>November 17, 2014</last_update_submitted>
  <last_update_submitted_qc>November 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Myung Hee Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Prewarmed fluid</keyword>
  <keyword>monitored anesthesia care</keyword>
  <keyword>core body temperature</keyword>
  <keyword>anesthetic satisfaction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothermia</mesh_term>
  </condition_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/NCT01722955
org study id: Prewarmed fluid
nct id: NCT01722955
lead sponsor: 
has dmc: Yes
The aim of the study is to compare effect of pre-warmed intravenous fluids on the early
      outcomes in ambulatory patients undergoing monitored anesthesia care.
Monitored anesthesia care (MAC) has been increasing in fast track anesthesia for ambulatory
      or outpatient surgery. MAC provides lower anesthetic agents than general anesthesia, however
      it has been shown to result high anesthetic complication rate because of negligent
      monitoring. Therefore, aim of this study is to investigate the effect of pre-warmed
      intravenous fluids on the core body temperature and the early outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Tympanic membrane temperature
time frame: 30min after anesthetic induction
description: Preoperative dehydration will be supplemented with 10ml/kg of lactate Ringer's solution at the beginning of the anesthetic induction. 30 min after anesthetic induction is nearly after administering the fixed volume.
measure: Postoperative chilling and shivering
time frame: on arrival at the postanesthetic care unit ( 1hour after the anesthetic induction)
description: Degree of chilling and shivering will be evaluated at the postanesthesia care unit after the surgery.
arm group label: Pre-warmed fluids
arm group type: Experimental
description: Pre-warmed fluids will be prepared for 8hous in 41℃ set hot cabinet.
arm group label: Room temperature fluids
arm group type: Experimental
description: Room temperature fluids will be stored at ambient temperature.
intervention type: Other
intervention name: Pre-warmed fluids
description: IV fluid will be stored at 41℃ set hot cabinet for 8hours
arm group label: Pre-warmed fluids
other name: Warming intravenous (IV) fluid
intervention type: Other
intervention name: Room temperature fluids
description: Room temperature fluid will be stored at ambient temperature
arm group label: Room temperature fluids
other name: No warming intravenous fluids
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Myung Hee Kim, MD,PhD
role: Principal Investigator
affiliation: Samsung MC
facility: 
country: Korea, Republic of
citation: Yokoyama K, Suzuki M, Shimada Y, Matsushima T, Bito H, Sakamoto A. Effect of administration of pre-warmed intravenous fluids on the frequency of hypothermia following spinal anesthesia for Cesarean delivery. J Clin Anesth. 2009 Jun;21(4):242-8. doi: 10.1016/j.jclinane.2008.12.010. Epub 2009 Jun 6.
PMID: 19502035
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Myung Hee Kim
investigator title: Professor
mesh term: Hypothermia