xml: <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/NCT06017076</url>
    </required_header>
    <id_info>
      <org_study_id>SFY2023-MZ8-3</org_study_id>
      <nct_id>NCT06017076</nct_id>
    </id_info>
    <brief_title>Effect of Preoperative Oral Energy Drinks Compared to Warming Matress on Body Temperature During Combined Spinal-epidural Anesthesia for Elective Cesarean Delivery.</brief_title>
    <official_title>Effect of Preoperative Oral Energy Drinks Compared to Warming Matress on Body Temperature During Combined Spinal-epidural Anesthesia for Elective Cesarean Delivery: a Randomised Non-inferiority Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University People's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University People's Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        It is not known which is better for intraoperative temperature protection, warming matress or&#xD;
        preoperative oral functional drinks in elective cesarean section. We plan to conduct a non&#xD;
        inferiority randomized trial to clarify this problem.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Core temperature change</measure>
      <time_frame>Before the operation, and every 10 minutes during the operation until the end of the operation.</time_frame>
      <description>The minimum value of intraoperative ear temperature minus the preoperative baseline ear temperature.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Skin temperature changes</measure>
      <time_frame>Before the operation, and every 10 minutes during the operation until the end of the operation.</time_frame>
      <description>The minimum value of intraoperative skin temperature minus the preoperative baseline skin temperature.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>hypotension</measure>
      <time_frame>Intraoperative</time_frame>
      <description>Number of Participants with systolic blood pressure reduction &gt;20% baseline value or systolic blood pressure &lt;90 mm Hg before delivery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence of nausea in pregnant women</measure>
      <time_frame>Intraoperative</time_frame>
      <description>Anesthesiologist observes combined patient dictation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Umbilical artery blood base excess</measure>
      <time_frame>30sec after delivery</time_frame>
      <description>base excess of fetal umbilical artery blood</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence of vomiting in pregnant women</measure>
      <time_frame>Intraoperative</time_frame>
      <description>Anesthesiologist observes combined patient dictation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence of shivering in pregnant women</measure>
      <time_frame>Intraoperative</time_frame>
      <description>Anesthesiologist observes combined patient dictation</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">280</enrollment>
    <condition>Cesarean Section Complications</condition>
    <arm_group>
      <arm_group_label>warming matress group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>From the end of anesthesia, warming matriss at 40 ℃ was used for insulation until the end of surgery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>oral functional drinks group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients drank energy drinks (Red Bull®) 250ml about 2-2.5 hours before operation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Oral energy drinks</intervention_name>
      <description>Patients drank energy drinks (Red Bull®) 250ml about 2-2.5 hours before operation.</description>
      <arm_group_label>oral functional drinks group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Warming matress</intervention_name>
      <description>From the end of anesthesia, warming matriss at 40 ℃ was used to keep warm until the end of surgery.</description>
      <arm_group_label>warming matress group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women pregnant with a single fetus;&#xD;
  &#xD;
            -  American Society of Anesthesiologists (ASA) physical status II;&#xD;
  &#xD;
            -  Willingness to undergo elective cesarean delivery under CSEA;&#xD;
  &#xD;
            -  An age of 20-40 years;&#xD;
  &#xD;
            -  A body mass index (BMI) of 19-30 kg·m-2;&#xD;
  &#xD;
            -  A gestational age of 38-40 weeks.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Contraindications for CSEA;&#xD;
  &#xD;
            -  A diagnosis of delayed gastric emptying, hyperemesis gravidarum until late pregnancy,&#xD;
               or consumption of drugs that affect gastrointestinal motility within 3 days before&#xD;
               surgery;&#xD;
  &#xD;
            -  Preoperative body temperature &gt;38°C or &lt;36°C or the use of drugs that affect body&#xD;
               temperature;&#xD;
  &#xD;
            -  Pregnancy combined with diabetes, hypertension, or metabolic disorders (eg,&#xD;
               hypothyroidism or hyperthyroidism);&#xD;
  &#xD;
            -  Ear diseases (eg, otitis media, tympanic membrane perforation, etc) affecting&#xD;
               measurement of ear temperature .&#xD;
  &#xD;
            -  Patients who were simultaneously undergoing other operations (eg, removal of uterine&#xD;
               fibroids and ovarian cysts) or had a surgical time &gt;1.5 hours;&#xD;
  &#xD;
            -  Patients with blood transfusion or autologous blood transfusion intraoperatively;&#xD;
  &#xD;
            -  Patients who did not receive the anesthetic specified in the protocol;&#xD;
  &#xD;
            -  Patients who failed to drink adequate energy drinks as prescribed before surgery.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yi Feng</last_name>
      <phone>13601083503</phone>
      <email>doctor_yifeng@sina.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking University People's Hospital</investigator_affiliation>
      <investigator_full_name>Yi Feng, MD</investigator_full_name>
      <investigator_title>Head of anesthesiology</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06017076
  org study id: SFY2023-MZ8-3
  nct id: NCT06017076
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  It is not known which is better for intraoperative temperature protection, warming matress or
        preoperative oral functional drinks in elective cesarean section. We plan to conduct a non
        inferiority randomized trial to clarify this problem.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Core temperature change
  time frame: Before the operation, and every 10 minutes during the operation until the end of the operation.
  description: The minimum value of intraoperative ear temperature minus the preoperative baseline ear temperature.
  measure: Skin temperature changes
  time frame: Before the operation, and every 10 minutes during the operation until the end of the operation.
  description: The minimum value of intraoperative skin temperature minus the preoperative baseline skin temperature.
  measure: hypotension
  time frame: Intraoperative
  description: Number of Participants with systolic blood pressure reduction >20% baseline value or systolic blood pressure <90 mm Hg before delivery
  measure: The incidence of nausea in pregnant women
  time frame: Intraoperative
  description: Anesthesiologist observes combined patient dictation.
  measure: Umbilical artery blood base excess
  time frame: 30sec after delivery
  description: base excess of fetal umbilical artery blood
  measure: The incidence of vomiting in pregnant women
  time frame: Intraoperative
  description: Anesthesiologist observes combined patient dictation
  measure: The incidence of shivering in pregnant women
  time frame: Intraoperative
  description: Anesthesiologist observes combined patient dictation
  arm group label: warming matress group
  arm group type: Placebo Comparator
  description: From the end of anesthesia, warming matriss at 40 ℃ was used for insulation until the end of surgery.
  arm group label: oral functional drinks group
  arm group type: Experimental
  description: Patients drank energy drinks (Red Bull®) 250ml about 2-2.5 hours before operation.
  intervention type: Other
  intervention name: Oral energy drinks
  description: Patients drank energy drinks (Red Bull®) 250ml about 2-2.5 hours before operation.
  arm group label: oral functional drinks group
  intervention type: Device
  intervention name: Warming matress
  description: From the end of anesthesia, warming matriss at 40 ℃ was used to keep warm until the end of surgery.
  arm group label: warming matress group
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Yi Feng
  phone: 13601083503
  email: doctor_yifeng@sina.com
  responsible party type: Principal Investigator
  investigator affiliation: Peking University People's Hospital
  investigator full name: Yi Feng, MD
  investigator title: Head of anesthesiology
  sharing ipd: Yes