<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/NCT03248791</url>
  </required_header>
  <id_info>
    <org_study_id>N-86-2017</org_study_id>
    <nct_id>NCT03248791</nct_id>
  </id_info>
  <brief_title>Vasopressor Infusion in Cesarean Delivery</brief_title>
  <official_title>Comparison of Two Vasopressor Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Trial</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>
      Comparison will be conducted between continuous variable infusions of both drugs&#xD;
      (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min&#xD;
      respectively for prophylaxis against Post-spinal hypotension during cesarean delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery&#xD;
      (CD). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during&#xD;
      CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE)&#xD;
      is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its&#xD;
      marked cardiac depressant nature. Norepinephrine (NE) is a potent vasopressor characterized&#xD;
      by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic&#xD;
      activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these&#xD;
      pharmacological properties would make NE an attractive alternative to PE. In this study, we&#xD;
      will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75&#xD;
      mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against PSH during CD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 20, 2017</start_date>
  <completion_date type="Anticipated">March 10, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2022</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 post-spinal anesthesia hypotension</measure>
    <time_frame>30 minutes after spinal anesthesia</time_frame>
    <description>Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of severe post-spinal anesthesia hypotension</measure>
    <time_frame>30 minutes after spinal anesthesia</time_frame>
    <description>Defined as the percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of severe delivery hypotension</measure>
    <time_frame>10 minutes after delivery</time_frame>
    <description>Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>systolic blood pressure</measure>
    <time_frame>2 hours after subarachnoid block</time_frame>
    <description>systolic blood pressure measured in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diastolic blood pressure</measure>
    <time_frame>2 hours after subarachnoid block</time_frame>
    <description>diastolic blood pressure measured in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>2 hours after subarachnoid block</time_frame>
    <description>number of heart beats per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>APGAR score</measure>
    <time_frame>10 minutes after delivery</time_frame>
    <description>APGAR score of the fetus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of reactive hypertension</measure>
    <time_frame>2 hours after spinal anesthesia</time_frame>
    <description>Defined as the percentage of patients with increased systolic blood pressure more than 80% of the baseline reading</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Cesarean Section Complications</condition>
  <condition>Spinal Anesthesia</condition>
  <arm_group>
    <arm_group_label>Phenylephrine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Will receive spinal anesthesia using Bupivacaine. Then, phenylephrine infusion by a starting rate of 0.75 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Norepinephrine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine infusion by a starting rate of 0.1 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phenylephrine</intervention_name>
    <description>Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.</description>
    <arm_group_label>Phenylephrine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Norepinephrine</intervention_name>
    <description>Norepinephrine variable infusion with a starting rate of 0.1 mcg/Kg/min.</description>
    <arm_group_label>Norepinephrine</arm_group_label>
    <other_name>noradrenaline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg</description>
    <arm_group_label>Norepinephrine</arm_group_label>
    <arm_group_label>Phenylephrine</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  full term&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  scheduled for cesarean section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pre-ecpamsia&#xD;
&#xD;
          -  eclampsia&#xD;
&#xD;
          -  bleeding&#xD;
&#xD;
          -  cardiac dysfuction&#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>
  <overall_contact>
    <last_name>Ahmed Hasanin, Professor</last_name>
    <phone>+201095076954</phone>
    <email>ahmedmohamedhasanin@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ahmed Shash, Professor</last_name>
      <phone>+201001033999</phone>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>September 22, 2021</last_update_submitted>
  <last_update_submitted_qc>September 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2021</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>Assistant professor</investigator_title>
  </responsible_party>
  <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>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/NCT03248791
org study id: N-86-2017
nct id: NCT03248791
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Comparison will be conducted between continuous variable infusions of both drugs
      (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min
      respectively for prophylaxis against Post-spinal hypotension during cesarean delivery.
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery
      (CD). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during
      CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE)
      is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its
      marked cardiac depressant nature. 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 PE. In this study, we
      will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75
      mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against PSH during CD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: incidence of post-spinal anesthesia hypotension
time frame: 30 minutes after spinal anesthesia
description: Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading
measure: incidence of severe post-spinal anesthesia hypotension
time frame: 30 minutes after spinal anesthesia
description: Defined as the percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading
measure: incidence of severe delivery hypotension
time frame: 10 minutes after delivery
description: Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading
measure: systolic blood pressure
time frame: 2 hours after subarachnoid block
description: systolic blood pressure measured in mmHg
measure: diastolic blood pressure
time frame: 2 hours after subarachnoid block
description: diastolic blood pressure measured in mmHg
measure: heart rate
time frame: 2 hours after subarachnoid block
description: number of heart beats per minute
measure: APGAR score
time frame: 10 minutes after delivery
description: APGAR score of the fetus
measure: incidence of reactive hypertension
time frame: 2 hours after spinal anesthesia
description: Defined as the percentage of patients with increased systolic blood pressure more than 80% of the baseline reading
arm group label: Phenylephrine
arm group type: Active Comparator
description: Will receive spinal anesthesia using Bupivacaine. Then, phenylephrine infusion by a starting rate of 0.75 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure
arm group label: Norepinephrine
arm group type: Experimental
description: Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine infusion by a starting rate of 0.1 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure
intervention type: Drug
intervention name: Phenylephrine
description: Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.
arm group label: Phenylephrine
intervention type: Drug
intervention name: Norepinephrine
description: Norepinephrine variable infusion with a starting rate of 0.1 mcg/Kg/min.
arm group label: Norepinephrine
other name: noradrenaline
intervention type: Drug
intervention name: Bupivacaine
description: Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg
arm group label: Norepinephrine
arm group label: Phenylephrine
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
last name: Ahmed Hasanin, Professor
phone: +201095076954
email: ahmedmohamedhasanin@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Hasanin
investigator title: Assistant professor
mesh term: Phenylephrine
mesh term: Oxymetazoline
mesh term: Norepinephrine
mesh term: Bupivacaine
sharing ipd: No