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/NCT05993182</url>
    </required_header>
    <id_info>
      <org_study_id>669/10/22</org_study_id>
      <nct_id>NCT05993182</nct_id>
    </id_info>
    <brief_title>Comparative Study Among Different Doses of Ephedrine During Elective Cesarean Section Under Subarachnoid Block.</brief_title>
    <official_title>Comparative Study Among Different Doses of Ephedrine During Elective Cesarean Section Under Subarachnoid Block - Time to Event Analysis.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aswan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Aswan University</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 the time of second hypotension after administration of three different doses of&#xD;
        ephedrine 5,10,15 mg&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In cesarean section, under subarachnoid block the most common complication is hypotension&#xD;
        with a reported incidence greater than 80%. Hypotension may occur even after left uterine&#xD;
        displacement and preloading with crystalloid. The severity of hypotension depends on the&#xD;
        degree of aortocaval compression syndrome, the amount of crystalloid preloading, doses of&#xD;
        local anesthetic drugs administered. The most effective treatment of hypotension associated&#xD;
        with cesarean section under subarachnoid block is the administration of vasopressor drugs.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 20, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Survival analysis or time until an event occurs</measure>
      <time_frame>Intraoperatively</time_frame>
      <description>The study time is a30 minute and blood pressure is measured automatically non invasive at 3-minute intervals. If systolic blood pressure decreased more than 20% from the baseline(Event)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Starting point or Base line time</measure>
      <time_frame>Intraoperatively</time_frame>
      <description>Starting point or Base line time is a first hypotension</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Survival time</measure>
      <time_frame>Intraoperatively</time_frame>
      <description>Free of event(No hypotension) at any time after base line</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Anesthesia</condition>
    <condition>Cesarean Section Complications</condition>
    <condition>Subarachnoid Block</condition>
    <arm_group>
      <arm_group_label>Group-I</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>received 5mg of Ephedrine after the first hypotension [ Base line time or starting point is first hypotension]</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group-II</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>received 10mg of Ephedrine after the first hypotension [ Base line time or starting point is first hypotension]</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group-III</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>15mg bolus dose of ephedrine IV after the first hypotension [ Base line time or starting point is first hypotension]</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ephedrine 5mg</intervention_name>
      <description>Patients received 5mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension]</description>
      <arm_group_label>Group-I</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ephedrine 10mg</intervention_name>
      <description>Patients received 10mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension]</description>
      <arm_group_label>Group-II</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ephedrine 15mg</intervention_name>
      <description>Patients received 15mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension]</description>
      <arm_group_label>Group-III</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  American Society of Anesthesiologists 1 and 2 patients&#xD;
  &#xD;
            -  Gestational amenorrhea of &gt; 32 weeks&#xD;
  &#xD;
            -  Elective cesarean section&#xD;
  &#xD;
            -  Patient willing for spinal anesthesia.&#xD;
  &#xD;
            -  Singleton pregnancy with cephalic presentation.&#xD;
  &#xD;
            -  Baseline systolic blood pressure between 100-140 mmHg and diastolic blood pressure&#xD;
               between 70-89 mmHg.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any contraindication to spinal anesthesia, i.e., local infection at the site of&#xD;
               injection&#xD;
  &#xD;
            -  valvular heat diseases&#xD;
  &#xD;
            -  bleeding tendency&#xD;
  &#xD;
            -  any co-morbidity like diabetes mellitus&#xD;
  &#xD;
            -  liver cirrhosis&#xD;
  &#xD;
            -  renal failure&#xD;
  &#xD;
            -  any obstetric complications like placenta previa&#xD;
  &#xD;
            -  pregnancy-induced hypertension or HELLP syndrome&#xD;
  &#xD;
            -  multiple gestations&#xD;
  &#xD;
            -  fetal malformation&#xD;
  &#xD;
            -  coagulopathies&#xD;
  &#xD;
            -  morbid obesity and spine deformity&#xD;
  &#xD;
            -  profound hypotension (total spinal) bradycardia and need atropine and severe bleeding&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Aswan University</name>
        <address>
          <city>Aswan</city>
          <zip>81511</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ayman M Eldemrdash, MBBCh</last_name>
        <phone>+20 100 129 6116</phone>
        <email>toka6116abdo@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Aswan University</investigator_affiliation>
      <investigator_full_name>Ayman Mohamady Eldemrdash</investigator_full_name>
      <investigator_title>Doctor Ayman Mohamady Eldemrdash</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ephedrine</mesh_term>
      <mesh_term>Pseudoephedrine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The data will be available upon a reasonable request from the corresponding author after the end of study for one year.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>after the end of study for one year.</ipd_time_frame>
      <ipd_access_criteria>The data will be available upon a reasonable request from the corresponding author</ipd_access_criteria>
    </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/NCT05993182
  org study id: 669/10/22
  nct id: NCT05993182
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  compare the time of second hypotension after administration of three different doses of
        ephedrine 5,10,15 mg
  In cesarean section, under subarachnoid block the most common complication is hypotension
        with a reported incidence greater than 80%. Hypotension may occur even after left uterine
        displacement and preloading with crystalloid. The severity of hypotension depends on the
        degree of aortocaval compression syndrome, the amount of crystalloid preloading, doses of
        local anesthetic drugs administered. The most effective treatment of hypotension associated
        with cesarean section under subarachnoid block is the administration of vasopressor drugs.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Survival analysis or time until an event occurs
  time frame: Intraoperatively
  description: The study time is a30 minute and blood pressure is measured automatically non invasive at 3-minute intervals. If systolic blood pressure decreased more than 20% from the baseline(Event)
  measure: Starting point or Base line time
  time frame: Intraoperatively
  description: Starting point or Base line time is a first hypotension
  measure: Survival time
  time frame: Intraoperatively
  description: Free of event(No hypotension) at any time after base line
  arm group label: Group-I
  arm group type: Active Comparator
  description: received 5mg of Ephedrine after the first hypotension [ Base line time or starting point is first hypotension]
  arm group label: Group-II
  arm group type: Active Comparator
  description: received 10mg of Ephedrine after the first hypotension [ Base line time or starting point is first hypotension]
  arm group label: Group-III
  arm group type: Active Comparator
  description: 15mg bolus dose of ephedrine IV after the first hypotension [ Base line time or starting point is first hypotension]
  intervention type: Drug
  intervention name: Ephedrine 5mg
  description: Patients received 5mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension]
  arm group label: Group-I
  intervention type: Drug
  intervention name: Ephedrine 10mg
  description: Patients received 10mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension]
  arm group label: Group-II
  intervention type: Drug
  intervention name: Ephedrine 15mg
  description: Patients received 15mg bolus dose of ephedrine Intravenous after the first hypotension [ Base line time or starting point is first hypotension]
  arm group label: Group-III
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Aswan University
  investigator full name: Ayman Mohamady Eldemrdash
  investigator title: Doctor Ayman Mohamady Eldemrdash
  mesh term: Ephedrine
  mesh term: Pseudoephedrine
  sharing ipd: Yes
  ipd description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
  ipd info type: Study Protocol
  ipd time frame: after the end of study for one year.
  ipd access criteria: The data will be available upon a reasonable request from the corresponding author