<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/NCT03234816</url>
  </required_header>
  <id_info>
    <org_study_id>N_66_2017</org_study_id>
    <nct_id>NCT03234816</nct_id>
  </id_info>
  <brief_title>Vasopressor Prophylaxis After Spinal Anesthesia</brief_title>
  <official_title>Vasopressor Prophylaxis After Spinal Anesthesia: A Dose Finding Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      Norepinephrine has been recently introduced as a prophylactic vasopressor during Cesarean&#xD;
      delivery with promising results ; However, the optimum dose for efficient prophylaxis with&#xD;
      the least side effects is not known. In this study, we will compare three doses (0.05, 0.1,&#xD;
      0.15 mcg/Kg/min) of norepinephrine for prophylaxis against Post-Spinal hypotension during&#xD;
      cesarean delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery&#xD;
      (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal&#xD;
      hypotension (PSH) during CD.&#xD;
&#xD;
      Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic&#xD;
      activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a&#xD;
      vasopressor with minimal cardiac depressant effect; these pharmacological properties would&#xD;
      make NE an attractive alternative to phenylephrine and ephedrine (the most commonly used&#xD;
      vasopressors in obstetric anesthesia).&#xD;
&#xD;
      Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with&#xD;
      promising results; However, the optimum dose for efficient prophylaxis with the least side&#xD;
      effects is not known.&#xD;
&#xD;
      In this study, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for&#xD;
      prophylaxis against PSH during CD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2017</start_date>
  <completion_date type="Actual">December 10, 2018</completion_date>
  <primary_completion_date type="Actual">November 2, 2018</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of postspinal hypotension</measure>
    <time_frame>30 minutes after spinal anesthesia</time_frame>
    <description>The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>90 minutes after spinal anesthesia</time_frame>
    <description>heart rate after spinal anesthesia measured in beat per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vomiting</measure>
    <time_frame>120 minutes after spinal anesthesia</time_frame>
    <description>incidence of vomiting after spinal anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>nausea</measure>
    <time_frame>120 minutes after spinal anesthesia</time_frame>
    <description>incidence of nausea after spinal anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ephedrine consumption</measure>
    <time_frame>60 minutes after spinal anesthesia</time_frame>
    <description>total amount of ephedrine consumed after spinal anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atropine consumption</measure>
    <time_frame>60 minutes after spinal anesthesia</time_frame>
    <description>total amount of atropine consumed after spinal anesthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>APGAR score</measure>
    <time_frame>10 minutes after delivery</time_frame>
    <description>APGAR score of the delivered fetus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of severe postspinal hypotension</measure>
    <time_frame>30 minutes after spinal anesthesia</time_frame>
    <description>The number of patients who develop hypotension (defined as decreased SBP less than 60% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>arterial blood pressure</measure>
    <time_frame>90 minutes after spinal anesthesia</time_frame>
    <description>arterial blood pressure after spinal anesthesia measured in mmHg</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">270</enrollment>
  <condition>Cesarean Section Complications</condition>
  <arm_group>
    <arm_group_label>- 0.05 mcg /Kg/min group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>will receive norepinephrine 0.05 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>- 0.1 mcg /Kg/min group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>will receive norepinephrine 0.1 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>- 0.15 mcg /Kg/min group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>will receive norepinephrine 0.15 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Norepinephrine 0.05 mcg /Kg/min</intervention_name>
    <description>Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia</description>
    <arm_group_label>- 0.05 mcg /Kg/min group</arm_group_label>
    <other_name>noradrenaline infusion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Norepinephrine 0.1 mcg /Kg/min</intervention_name>
    <description>Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia</description>
    <arm_group_label>- 0.1 mcg /Kg/min group</arm_group_label>
    <other_name>noradrenaline infusion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Norepinephrine 0.15 mcg /Kg/min</intervention_name>
    <description>Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia</description>
    <arm_group_label>- 0.15 mcg /Kg/min group</arm_group_label>
    <other_name>noradrenaline infusion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>10 mg Bupivacaine intra-thecal for spinal anesthesia</description>
    <arm_group_label>- 0.05 mcg /Kg/min group</arm_group_label>
    <arm_group_label>- 0.1 mcg /Kg/min group</arm_group_label>
    <arm_group_label>- 0.15 mcg /Kg/min group</arm_group_label>
    <other_name>marcaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  full term singleton pregnant women&#xD;
&#xD;
          -  Scheduled for elective Cesarean Delivery&#xD;
&#xD;
          -  Aged between 18 and 40 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac morbidities&#xD;
&#xD;
          -  Hypertensive disorders of pregnancy,&#xD;
&#xD;
          -  Peripartum bleeding&#xD;
&#xD;
          -  Baseline systolic blood pressure (SBP) &lt; 100 mmHg&#xD;
&#xD;
          -  Body mass index &gt; 35&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Mukhtar, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Head of research committee section in anesthesia department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>January 13, 2019</last_update_submitted>
  <last_update_submitted_qc>January 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Hasanin</investigator_full_name>
    <investigator_title>Principal investigator, Lecturer of anesthesia and critical care medicine</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Norepinephrine</mesh_term>
    <mesh_term>Bupivacaine</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/NCT03234816
org study id: N_66_2017
nct id: NCT03234816
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Norepinephrine has been recently introduced as a prophylactic vasopressor during Cesarean
      delivery with promising results ; However, the optimum dose for efficient prophylaxis with
      the least side effects is not known. In this study, we will compare three doses (0.05, 0.1,
      0.15 mcg/Kg/min) of norepinephrine for prophylaxis against Post-Spinal hypotension during
      cesarean delivery.
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery
      (CD). Using vasopressors have been considered a gold standard for prevention of post-spinal
      hypotension (PSH) during CD.

      Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic
      activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a
      vasopressor with minimal cardiac depressant effect; these pharmacological properties would
      make NE an attractive alternative to phenylephrine and ephedrine (the most commonly used
      vasopressors in obstetric anesthesia).

      Norepinephrine has been recently introduced as a prophylactic vasopressor during CD with
      promising results; However, the optimum dose for efficient prophylaxis with the least side
      effects is not known.

      In this study, we will compare three doses (0.05, 0.1, 0.15 mcg/Kg/min) of norepinephrine for
      prophylaxis against PSH during CD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: incidence of postspinal hypotension
time frame: 30 minutes after spinal anesthesia
description: The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group
measure: heart rate
time frame: 90 minutes after spinal anesthesia
description: heart rate after spinal anesthesia measured in beat per minute
measure: vomiting
time frame: 120 minutes after spinal anesthesia
description: incidence of vomiting after spinal anesthesia
measure: nausea
time frame: 120 minutes after spinal anesthesia
description: incidence of nausea after spinal anesthesia
measure: ephedrine consumption
time frame: 60 minutes after spinal anesthesia
description: total amount of ephedrine consumed after spinal anesthesia
measure: Atropine consumption
time frame: 60 minutes after spinal anesthesia
description: total amount of atropine consumed after spinal anesthesia
measure: APGAR score
time frame: 10 minutes after delivery
description: APGAR score of the delivered fetus
measure: incidence of severe postspinal hypotension
time frame: 30 minutes after spinal anesthesia
description: The number of patients who develop hypotension (defined as decreased SBP less than 60% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group
measure: arterial blood pressure
time frame: 90 minutes after spinal anesthesia
description: arterial blood pressure after spinal anesthesia measured in mmHg
arm group label: - 0.05 mcg /Kg/min group
arm group type: Experimental
description: will receive norepinephrine 0.05 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
arm group label: - 0.1 mcg /Kg/min group
arm group type: Experimental
description: will receive norepinephrine 0.1 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
arm group label: - 0.15 mcg /Kg/min group
arm group type: Experimental
description: will receive norepinephrine 0.15 mcg /Kg/min after spinal anesthesia by bupivacaine till five-minutes after delivery of the fetus
intervention type: Drug
intervention name: Norepinephrine 0.05 mcg /Kg/min
description: Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
arm group label: - 0.05 mcg /Kg/min group
other name: noradrenaline infusion
intervention type: Drug
intervention name: Norepinephrine 0.1 mcg /Kg/min
description: Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
arm group label: - 0.1 mcg /Kg/min group
other name: noradrenaline infusion
intervention type: Drug
intervention name: Norepinephrine 0.15 mcg /Kg/min
description: Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
arm group label: - 0.15 mcg /Kg/min group
other name: noradrenaline infusion
intervention type: Drug
intervention name: Bupivacaine
description: 10 mg Bupivacaine intra-thecal for spinal anesthesia
arm group label: - 0.05 mcg /Kg/min group
arm group label: - 0.1 mcg /Kg/min group
arm group label: - 0.15 mcg /Kg/min group
other name: marcaine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Ahmed Mukhtar, Professor
role: Study Director
affiliation: Head of research committee section in anesthesia department
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Hasanin
investigator title: Principal investigator, Lecturer of anesthesia and critical care medicine
mesh term: Norepinephrine
mesh term: Bupivacaine
sharing ipd: No