<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/NCT02969239</url>
  </required_header>
  <id_info>
    <org_study_id>ALee-OB-2016-1</org_study_id>
    <nct_id>NCT02969239</nct_id>
  </id_info>
  <brief_title>Norepinephrine and Phenylephrine for Maternal Cardiac Output During Spinal Anesthesia for Elective Cesarean Delivery</brief_title>
  <official_title>Norepinephrine and Phenylephrine for Cesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jeju National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jeju National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare norepinephrine and phenylephrine on the effects of&#xD;
      maintaining the cardiac output in Cesarean section under spinal anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CO was measured using the NICOM® monitor. Bioreactance, a development from impedance&#xD;
      technology, is also emerging as an accessible mode of continuous CO monitoring in the&#xD;
      operating room and can provide valuable insight into the hemodynamic effects of our&#xD;
      interventions. This method of monitoring provides continuous CO, stroke volume (SV) and heart&#xD;
      rate (HR) monitoring, and intermittent BP and SVR assessments at 1-minute intervals.&#xD;
&#xD;
      Either phenylephrine (100 mcg/ml) or norepinephrine (0.5 mcg/ml) in 50-ml syringe that were&#xD;
      labeled &quot;study drug&quot;. She was not involved in patient's care or study assessment.&#xD;
&#xD;
      The hypotension was defined as systolic blood pressure &lt;80% of baseline or &lt; 90 mmHg, and&#xD;
      managed with study drug (1 ml) intravenously. The bradycardia was defined as HR &lt; 60&#xD;
      beats/min and was recorded and managed with atropine (0.5 mg) intravenously as HR &lt; 45&#xD;
      beats/min. The presence of nausea and vomiting was measured on a 3 point scale (1 = no nausea&#xD;
      and vomiting, 2 = nausea only, and 3 = both nausea and vomiting) and managed with ondansetron&#xD;
      (4mg) intravenously.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of cardiac index (L/min/m2)</measure>
    <time_frame>1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery</time_frame>
    <description>Change from Baseline at time 2, 3, 4, and 5</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change of Stroke volume (ml/beat)</measure>
    <time_frame>1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery</time_frame>
    <description>Change from Baseline at time 2, 3, 4, and 5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of Total Peripheral Resistance (dynes sec/cm3)</measure>
    <time_frame>1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery</time_frame>
    <description>Change from Baseline at time 2, 3, 4, and 5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of Systolic blood pressure (mmHg)</measure>
    <time_frame>1. initial (baseline); 2. 20 min after spinal anesthesia; 3. begin the surgery; 4. baby out; 5. the end of surgery</time_frame>
    <description>Change from Baseline at time 2, 3, 4, and 5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of heart rate (beats per minute)</measure>
    <time_frame>1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery</time_frame>
    <description>Change from Baseline at time 2, 3, 4, and 5</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Apgar score</measure>
    <time_frame>1 min after baby out, 5 min after baby out</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Hypotension</condition>
  <arm_group>
    <arm_group_label>norepinephrine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>norepinephrine 5mcg intravenously administered</description>
  </arm_group>
  <arm_group>
    <arm_group_label>phenylephrine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>phenylephrine 100mcg intravenously administered</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Norepinephrine</intervention_name>
    <description>bolus administered norepinephrine 5mcg intravenously, if SBP &lt;90mmHg or 20% decrease from baseline</description>
    <arm_group_label>norepinephrine</arm_group_label>
    <other_name>vasopressor given</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phenylephrine</intervention_name>
    <description>bolus administered phenylephrine 100mcg intravenously, if SBP &lt;90mmHg or 20% decrease from baseline</description>
    <arm_group_label>phenylephrine</arm_group_label>
    <other_name>vasopressor given</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA class I and II, term pregnancy (gestational age&gt;37weeks), planned spinal&#xD;
             anesthesia for elective cesarean section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  preexisting or gestational hypertension, cerebrovascular or cardiovascular disease,&#xD;
             any contraindication to the spinal anesthesia, fetal anormaly, weight&lt;50kg or &gt;100kg,&#xD;
             and height&lt;140cm or &gt;180cm.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AE RYOUNG LEE</last_name>
    <role>Study Director</role>
    <affiliation>Jeju National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>AE RYOUNG LEE</last_name>
    <phone>+82647171810</phone>
    <email>nanrong95@naver.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hyun Jung Kim</last_name>
    <phone>+82647172031</phone>
    <email>aeryoung.lee@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Jeju National University Hospital</name>
      <address>
        <city>Jeju</city>
        <zip>690-767</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>AE RYOUNG LEE</last_name>
      <phone>+82647171810</phone>
      <email>nanrong95@naver.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>October 13, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>March 8, 2017</last_update_submitted>
  <last_update_submitted_qc>March 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jeju National University Hospital</investigator_affiliation>
    <investigator_full_name>Ae ryoung Lee</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <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>
    <mesh_term>Vasoconstrictor Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02969239
org study id: ALee-OB-2016-1
nct id: NCT02969239
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare norepinephrine and phenylephrine on the effects of
      maintaining the cardiac output in Cesarean section under spinal anesthesia.
CO was measured using the NICOM® monitor. Bioreactance, a development from impedance
      technology, is also emerging as an accessible mode of continuous CO monitoring in the
      operating room and can provide valuable insight into the hemodynamic effects of our
      interventions. This method of monitoring provides continuous CO, stroke volume (SV) and heart
      rate (HR) monitoring, and intermittent BP and SVR assessments at 1-minute intervals.

      Either phenylephrine (100 mcg/ml) or norepinephrine (0.5 mcg/ml) in 50-ml syringe that were
      labeled "study drug". She was not involved in patient's care or study assessment.

      The hypotension was defined as systolic blood pressure <80% of baseline or < 90 mmHg, and
      managed with study drug (1 ml) intravenously. The bradycardia was defined as HR < 60
      beats/min and was recorded and managed with atropine (0.5 mg) intravenously as HR < 45
      beats/min. The presence of nausea and vomiting was measured on a 3 point scale (1 = no nausea
      and vomiting, 2 = nausea only, and 3 = both nausea and vomiting) and managed with ondansetron
      (4mg) intravenously.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: change of cardiac index (L/min/m2)
time frame: 1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery
description: Change from Baseline at time 2, 3, 4, and 5
measure: change of Stroke volume (ml/beat)
time frame: 1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery
description: Change from Baseline at time 2, 3, 4, and 5
measure: change of Total Peripheral Resistance (dynes sec/cm3)
time frame: 1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery
description: Change from Baseline at time 2, 3, 4, and 5
measure: change of Systolic blood pressure (mmHg)
time frame: 1. initial (baseline); 2. 20 min after spinal anesthesia; 3. begin the surgery; 4. baby out; 5. the end of surgery
description: Change from Baseline at time 2, 3, 4, and 5
measure: change of heart rate (beats per minute)
time frame: 1. initial (baseline); 2. 20 min after spinal anesthesia; 3. 1min after the surgery; 4. 1min after baby out; 5. 1min after the end of surgery
description: Change from Baseline at time 2, 3, 4, and 5
measure: Apgar score
time frame: 1 min after baby out, 5 min after baby out
arm group label: norepinephrine
arm group type: Experimental
description: norepinephrine 5mcg intravenously administered
arm group label: phenylephrine
arm group type: Active Comparator
description: phenylephrine 100mcg intravenously administered
intervention type: Drug
intervention name: Norepinephrine
description: bolus administered norepinephrine 5mcg intravenously, if SBP <90mmHg or 20% decrease from baseline
arm group label: norepinephrine
other name: vasopressor given
intervention type: Drug
intervention name: Phenylephrine
description: bolus administered phenylephrine 100mcg intravenously, if SBP <90mmHg or 20% decrease from baseline
arm group label: phenylephrine
other name: vasopressor given
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 45 Years
healthy volunteers: No
last name: AE RYOUNG LEE
role: Study Director
affiliation: Jeju National University Hospital
last name: AE RYOUNG LEE
phone: +82647171810
email: nanrong95@naver.com
last name: Hyun Jung Kim
phone: +82647172031
email: aeryoung.lee@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Jeju National University Hospital
investigator full name: Ae ryoung Lee
investigator title: Assistant Professor
mesh term: Hypotension
mesh term: Phenylephrine
mesh term: Oxymetazoline
mesh term: Norepinephrine
mesh term: Vasoconstrictor Agents
sharing ipd: Undecided