<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/NCT03248817</url>
  </required_header>
  <id_info>
    <org_study_id>N-87-2017</org_study_id>
    <nct_id>NCT03248817</nct_id>
  </id_info>
  <brief_title>Phenylephrine Infusion in Cesarean Delivery</brief_title>
  <official_title>Comparison of Different Protocols of Phenylephrine Infusion for Prophylaxis Against Post-spinal Hypotension During Cesarean Delivery</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>
      the investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75&#xD;
      mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop of reactive hypertension&#xD;
      occurred) and single shot (1.5 mcg/Kg) phenylephrine&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery&#xD;
      (CD). Phenylephrine (PE) is the most popular vasopressor for prevention of post-spinal&#xD;
      hypotension (PSH) during CD; however, the most appropriate protocol for PE administration is&#xD;
      still unknown. The most common PE protocols used for prophylaxis against PSH are: single&#xD;
      shot, fixed infusion, and variable infusion. A recent study reported that a dose of 1.5&#xD;
      mcg/Kg is the most suitable single-shot dose for prophylaxis. Another randomized controlled&#xD;
      trial compared four doses of PE infusion and reported that 25 mcg/Kg/min and 50 mcg/Kg/min&#xD;
      doses were the best doses for fixed infusion with accepted incidence of both PSH as well as&#xD;
      reactive hypertension. Using variable infusion rate of PE had been recently introduced in&#xD;
      another study with a starting dose of 0.75 mcg/Kg/min. The variable rate infusion showed very&#xD;
      good results regarding PSH. In this study, the investigators will compare variable infusion&#xD;
      of PE (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will&#xD;
      stop if reactive hypertension occurred) and single shot protocol (1.5 mcg/Kg)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 28, 2017</start_date>
  <completion_date type="Anticipated">May 25, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 15, 2020</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 percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus.</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 percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading during the period from intrathecal injection to delivery 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 percentage of patients with increased systolic blood pressure more than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>systolic blood pressure</measure>
    <time_frame>2 hours after spinal anesthesia</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>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">255</enrollment>
  <condition>Cesarean Section Complications</condition>
  <condition>Spinal Anesthesia</condition>
  <arm_group>
    <arm_group_label>single shot</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>spinal anesthesia will be performed using intrathecal bupivacaine. Then, a single shot phenylephrine (1.5 ug/Kg) will be administered</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fixed infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>spinal anesthesia will be performed using intrathecal bupivacaine. Then, fixed infusion phenylephrine will be administered at a dose of (0.75 mcg/Kg/min). the infusion will stop if reactive hypertension occurred</description>
  </arm_group>
  <arm_group>
    <arm_group_label>variable infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>spinal anesthesia will be performed using intrathecal bupivacaine. Then, variable infusion phenylephrine will be administered at a starting dose of (0.75 mcg/Kg/min). the infusion will be titrated according to blood pressure</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>single shot phenylephrine</intervention_name>
    <description>a single shot of phenylephrine (1.5 mcg/Kg) will be administrated intravenously</description>
    <arm_group_label>single shot</arm_group_label>
    <other_name>phenylephrine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fixed infusion phenylephrine</intervention_name>
    <description>fixed infusion of phenylephrine will be administrated at a rate of 0.75 mcg/Kg/min.</description>
    <arm_group_label>fixed infusion</arm_group_label>
    <other_name>phenylephrine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>variable infusion phenylephrine</intervention_name>
    <description>Variable infusion of phenylephrine will be administrated at a starting rate of 0.75 mcg/Kg/min.</description>
    <arm_group_label>variable infusion</arm_group_label>
    <other_name>phenylephrine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia</description>
    <arm_group_label>fixed infusion</arm_group_label>
    <arm_group_label>single shot</arm_group_label>
    <arm_group_label>variable infusion</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 delivery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-eclampsia&#xD;
&#xD;
          -  Eclampsia&#xD;
&#xD;
          -  Hemorrhage&#xD;
&#xD;
          -  Cardiac dysfunction&#xD;
&#xD;
          -  Baseline low heart rate (below 60 bpm)&#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 Hasanin, Lecturer</last_name>
      <phone>+2010095076954</phone>
      <email>ahmedmohamedhasanin@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2019</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>November 22, 2019</last_update_submitted>
  <last_update_submitted_qc>November 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 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>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>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/NCT03248817
org study id: N-87-2017
nct id: NCT03248817
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
the investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75
      mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop of reactive hypertension
      occurred) and single shot (1.5 mcg/Kg) phenylephrine
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery
      (CD). Phenylephrine (PE) is the most popular vasopressor for prevention of post-spinal
      hypotension (PSH) during CD; however, the most appropriate protocol for PE administration is
      still unknown. The most common PE protocols used for prophylaxis against PSH are: single
      shot, fixed infusion, and variable infusion. A recent study reported that a dose of 1.5
      mcg/Kg is the most suitable single-shot dose for prophylaxis. Another randomized controlled
      trial compared four doses of PE infusion and reported that 25 mcg/Kg/min and 50 mcg/Kg/min
      doses were the best doses for fixed infusion with accepted incidence of both PSH as well as
      reactive hypertension. Using variable infusion rate of PE had been recently introduced in
      another study with a starting dose of 0.75 mcg/Kg/min. The variable rate infusion showed very
      good results regarding PSH. In this study, the investigators will compare variable infusion
      of PE (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will
      stop if reactive hypertension occurred) and single shot protocol (1.5 mcg/Kg)
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 percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus.
measure: Incidence of severe Post-spinal anesthesia hypotension
time frame: 30 minutes after spinal anesthesia
description: Defined as percentage of patients with decreased systolic blood pressure less than 60% of the baseline reading during the period from intrathecal injection to delivery of the fetus.
measure: Incidence of reactive hypertension
time frame: 2 hours after spinal anesthesia
description: Defined as percentage of patients with increased systolic blood pressure more than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus.
measure: systolic blood pressure
time frame: 2 hours after spinal anesthesia
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
arm group label: single shot
arm group type: Experimental
description: spinal anesthesia will be performed using intrathecal bupivacaine. Then, a single shot phenylephrine (1.5 ug/Kg) will be administered
arm group label: fixed infusion
arm group type: Active Comparator
description: spinal anesthesia will be performed using intrathecal bupivacaine. Then, fixed infusion phenylephrine will be administered at a dose of (0.75 mcg/Kg/min). the infusion will stop if reactive hypertension occurred
arm group label: variable infusion
arm group type: Active Comparator
description: spinal anesthesia will be performed using intrathecal bupivacaine. Then, variable infusion phenylephrine will be administered at a starting dose of (0.75 mcg/Kg/min). the infusion will be titrated according to blood pressure
intervention type: Drug
intervention name: single shot phenylephrine
description: a single shot of phenylephrine (1.5 mcg/Kg) will be administrated intravenously
arm group label: single shot
other name: phenylephrine
intervention type: Drug
intervention name: fixed infusion phenylephrine
description: fixed infusion of phenylephrine will be administrated at a rate of 0.75 mcg/Kg/min.
arm group label: fixed infusion
other name: phenylephrine
intervention type: Drug
intervention name: variable infusion phenylephrine
description: Variable infusion of phenylephrine will be administrated at a starting rate of 0.75 mcg/Kg/min.
arm group label: variable infusion
other name: phenylephrine
intervention type: Drug
intervention name: Bupivacaine
description: Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia
arm group label: fixed infusion
arm group label: single shot
arm group label: variable infusion
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: Bupivacaine
sharing ipd: No