<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/NCT03833895</url>
  </required_header>
  <id_info>
    <org_study_id>CINI-AD-201812-3</org_study_id>
    <nct_id>NCT03833895</nct_id>
  </id_info>
  <brief_title>The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section</brief_title>
  <official_title>The Phenylephrine vs. Norepinephrine Infusion by Lidico Monitoring With Pregnancy Patients Undergoing Cesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China International Neuroscience Institution</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China International Neuroscience Institution</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine effect on fetus and&#xD;
      parturient during Cesarean Section&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine and control group&#xD;
           effect on parturient hemodynamic change (systolic blood pressure SBP, diastolic blood&#xD;
           pressure DBP,mean arterial pressure MAP,heart rate HR) and on LIDICO-rapid monitoring (&#xD;
           stroke volume SV, systemic vascular resistance SVR, cardiac output CO) and peripheral&#xD;
           vein (PV) blood gas during Cesarean Section.&#xD;
&#xD;
        2. Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine and control group&#xD;
           effect on fetus by blood gas of the umbilical vein (UV), umbilical artery (UA),&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Actual">September 2, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Systolic blood pressure (SBP) change as the one of hemodynamic outcome in general monitoring</measure>
    <time_frame>through study completion, an average of 24 hour</time_frame>
    <description>Systolic blood pressure (SBP)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diastolic blood pressure (DBP) change as the one of hemodynamic outcome in general monitoring</measure>
    <time_frame>Through study completion</time_frame>
    <description>Diastolic blood pressure (DBP)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean arterial pressure (MAP) change as the one of hemodynamic outcome in general monitoring</measure>
    <time_frame>An average of 24 hour</time_frame>
    <description>Mean arterial pressure (MAP)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate (HR) change as the one of hemodynamic outcome in general monitoring</measure>
    <time_frame>Through the study completion, an average of 24 hour</time_frame>
    <description>Heart rate (HR)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroke volume (SV) as the part of LIDICO-rapid monitoring parameter for parturient</measure>
    <time_frame>Through study completion, an average of 24 hour</time_frame>
    <description>Stroke volume (SV)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiac output (CO) as the part of LIDICO-rapid monitoring parameter for parturient</measure>
    <time_frame>Through study completion, an average of 24 hour</time_frame>
    <description>Cardiac output (CO)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systemic vascular resistance (SVR) as the part of LIDICO-rapid monitoring parameter for parturient</measure>
    <time_frame>Through study completion, an average of 24 hour</time_frame>
    <description>Systemic vascular resistance (SVR)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The benefits to the fetus based on umbilical vein (UV) blood gas</measure>
    <time_frame>Through study completion, an average of 24 hour</time_frame>
    <description>The umbilical vein (UV) blood gas</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The benefits to the fetus based on umbilical artery (UA) blood gas</measure>
    <time_frame>Through study completion, an average of 24 hour</time_frame>
    <description>The umbilical artery (UA) blood gas</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The benefits to parturient based on peripheral vein (PV) blood gas</measure>
    <time_frame>Through study completion, an average of 24 hour</time_frame>
    <description>Peripheral vein (PV) blood gas</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">238</enrollment>
  <condition>Cesarean Section Complications</condition>
  <arm_group>
    <arm_group_label>Group 1 Elements</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continuously infusion of 0.05ug/kg/min Norepinephrine during the Cesarean Section operation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 Elements</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continuously infusion of 0.25ug/kg/min phenylephrine during the Cesarean Section operation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3 Elements</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In the placebo-control group, 3 ml/kg/min of LR was administrated according to standard weight.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Norepinephrine</intervention_name>
    <description>0.05ug/kg/min Norepinephrine during Cesarean Section Operation</description>
    <arm_group_label>Group 1 Elements</arm_group_label>
    <other_name>Group 1 Elements</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phenylephrine</intervention_name>
    <description>0.25ug/kg/min phenylephrine during Cesarean Section Operation</description>
    <arm_group_label>Group 2 Elements</arm_group_label>
    <other_name>Group 2 Elements</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ringer's Solution</intervention_name>
    <description>3 ml/kg/min of LR was administrated according to standard weight.</description>
    <arm_group_label>Group 3 Elements</arm_group_label>
    <other_name>Group 3 Elements</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a healthy singleton pregnancy scheduled for elective cesarean delivery (CD) under&#xD;
             combined spinal-epidural anesthesia (CSEA),&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status I/II&#xD;
&#xD;
          -  20 to 40 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of mental disorder or epilepsy,&#xD;
&#xD;
          -  tricyclic or imipramine antidepressant use,&#xD;
&#xD;
          -  central nervous system (CNS) disease,&#xD;
&#xD;
          -  preexisting or pregnancy-induced hypertension,&#xD;
&#xD;
          -  lumbar injury,&#xD;
&#xD;
          -  severe hypovolemia,&#xD;
&#xD;
          -  allergy&#xD;
&#xD;
          -  history of hypersensitivity to vasopressor&#xD;
&#xD;
          -  body mass index (BMI) &gt;40 kg/m2,&#xD;
&#xD;
          -  infection at the puncture site&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tianlong Wang, MD,PHD</last_name>
    <role>Study Chair</role>
    <affiliation>Xuanwu Hospital, Beijing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xuanwu Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>February 6, 2020</last_update_submitted>
  <last_update_submitted_qc>February 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cesarean delivery</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Phenylephrine</mesh_term>
    <mesh_term>Oxymetazoline</mesh_term>
    <mesh_term>Norepinephrine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03833895
org study id: CINI-AD-201812-3
nct id: NCT03833895
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine effect on fetus and
      parturient during Cesarean Section
1. Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine and control group
           effect on parturient hemodynamic change (systolic blood pressure SBP, diastolic blood
           pressure DBP,mean arterial pressure MAP,heart rate HR) and on LIDICO-rapid monitoring (
           stroke volume SV, systemic vascular resistance SVR, cardiac output CO) and peripheral
           vein (PV) blood gas during Cesarean Section.

        2. Compare 0.05 μg/kg/min Norepinephrine and 0.25 μg/kg/min phenylephrine and control group
           effect on fetus by blood gas of the umbilical vein (UV), umbilical artery (UA),
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Systolic blood pressure (SBP) change as the one of hemodynamic outcome in general monitoring
time frame: through study completion, an average of 24 hour
description: Systolic blood pressure (SBP)
measure: Diastolic blood pressure (DBP) change as the one of hemodynamic outcome in general monitoring
time frame: Through study completion
description: Diastolic blood pressure (DBP)
measure: Mean arterial pressure (MAP) change as the one of hemodynamic outcome in general monitoring
time frame: An average of 24 hour
description: Mean arterial pressure (MAP)
measure: Heart rate (HR) change as the one of hemodynamic outcome in general monitoring
time frame: Through the study completion, an average of 24 hour
description: Heart rate (HR)
measure: Stroke volume (SV) as the part of LIDICO-rapid monitoring parameter for parturient
time frame: Through study completion, an average of 24 hour
description: Stroke volume (SV)
measure: Cardiac output (CO) as the part of LIDICO-rapid monitoring parameter for parturient
time frame: Through study completion, an average of 24 hour
description: Cardiac output (CO)
measure: Systemic vascular resistance (SVR) as the part of LIDICO-rapid monitoring parameter for parturient
time frame: Through study completion, an average of 24 hour
description: Systemic vascular resistance (SVR)
measure: The benefits to the fetus based on umbilical vein (UV) blood gas
time frame: Through study completion, an average of 24 hour
description: The umbilical vein (UV) blood gas
measure: The benefits to the fetus based on umbilical artery (UA) blood gas
time frame: Through study completion, an average of 24 hour
description: The umbilical artery (UA) blood gas
measure: The benefits to parturient based on peripheral vein (PV) blood gas
time frame: Through study completion, an average of 24 hour
description: Peripheral vein (PV) blood gas
arm group label: Group 1 Elements
arm group type: Experimental
description: Continuously infusion of 0.05ug/kg/min Norepinephrine during the Cesarean Section operation
arm group label: Group 2 Elements
arm group type: Experimental
description: Continuously infusion of 0.25ug/kg/min phenylephrine during the Cesarean Section operation
arm group label: Group 3 Elements
arm group type: Placebo Comparator
description: In the placebo-control group, 3 ml/kg/min of LR was administrated according to standard weight.
intervention type: Drug
intervention name: Norepinephrine
description: 0.05ug/kg/min Norepinephrine during Cesarean Section Operation
arm group label: Group 1 Elements
other name: Group 1 Elements
intervention type: Drug
intervention name: Phenylephrine
description: 0.25ug/kg/min phenylephrine during Cesarean Section Operation
arm group label: Group 2 Elements
other name: Group 2 Elements
intervention type: Drug
intervention name: Ringer's Solution
description: 3 ml/kg/min of LR was administrated according to standard weight.
arm group label: Group 3 Elements
other name: Group 3 Elements
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: Tianlong Wang, MD,PHD
role: Study Chair
affiliation: Xuanwu Hospital, Beijing
facility: 
country: China
responsible party type: Sponsor
mesh term: Phenylephrine
mesh term: Oxymetazoline
mesh term: Norepinephrine
sharing ipd: No