<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/NCT03015857</url>
  </required_header>
  <id_info>
    <org_study_id>cesarean sections</org_study_id>
    <nct_id>NCT03015857</nct_id>
  </id_info>
  <brief_title>Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension</brief_title>
  <official_title>A Comparison Between Phenylephrine and Norepinephrine Boluses in Prevention of Post-spinal Hypotension During Cesarean Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypotension following spinal anesthesia for cesarean section is a serious problem. In this&#xD;
      study we investigated the effect of the vasopressors phenylephrine and noradrenaline on&#xD;
      postspinal hypotension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On arrival to the operating room, an 18g cannula will be inserted and monitors will be&#xD;
      applied (electrocardiography - pulse oximetry - non-invasive blood pressure monitor).&#xD;
      Patients will receive spinal anesthesia with 500 ml rapid crystalloid co-load. Ten milligrams&#xD;
      heavy bupivacaine in addition to 20 mcg fentanyl will be injected in L3-L4 or L4-L5&#xD;
      interspace using 25 g spinal needle in the sitting position.&#xD;
&#xD;
      After spinal block, patients will be randomly allocated into one of two groups:&#xD;
&#xD;
        -  Phenylephrine group (n=100)&#xD;
&#xD;
        -  Norepinephrine group (n=100)&#xD;
&#xD;
      Patients who shows SBP above 140 mmHg or heart rate below 55 bpm after the first vasopressor&#xD;
      dose will not receive the infusion. The infusion will stop if the SBP was above 140 mmHg or&#xD;
      if the heart rate was below 55 bpm. Patients will be positioned in the supine position with&#xD;
      left lateral tilt. Block success will be assessed using pinprick, patients with failed block&#xD;
      will be excluded from the study. The highest sensory block level will be assessed after 5&#xD;
      minutes from intrathecal injection. Co-hydration will be continued till maximum of 1.5&#xD;
      litres.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>Phase 2</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of post spinal hypotension (PSH) 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>
    <time_frame>2 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>systolic and diastolic blood pressures measured in mm Hg</measure>
    <time_frame>2 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate measured in beats per minute</measure>
    <time_frame>2 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>nausea and vomiting measured in number of attacks</measure>
    <time_frame>2 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Adverse Anesthesia Outcome</condition>
  <arm_group>
    <arm_group_label>phenylephrine,</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>- Phenylephrine group (n=100): will receive 100 mcg phenylephrine as a single bolus just after intrathecal injection of 10 mg bupivacaine plus 20 mcg fentanyl. The dose will be diluted in 5 mL and given over seconds. A continuous infusion with placebo (normal saline) will start after the first bolus.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>norepinephrine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>- Norepinephrine group (n=100): will receive bolus of norepinephrine (10 mcg) directly after spinal block using 10 mg bupivacaine plus 20 mcg fentantanyl followed by continuous infusion of norepinephrine with a rate of 0.1 mcg/kg/min till delivery of the fetus.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>phenylephrine</intervention_name>
    <description>- phenylephrine; a vasopressor drug given to prevent post spinal hypotension</description>
    <arm_group_label>phenylephrine,</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Norepinephrine</intervention_name>
    <description>- norepinephrine; a vasopressor drug given to prevent post spinal hypotension</description>
    <arm_group_label>norepinephrine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>intrathecal bupivacaine 10 mg will be given in both groups</description>
    <arm_group_label>norepinephrine</arm_group_label>
    <arm_group_label>phenylephrine,</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>intrathecal fentanyl 20 mcg will be given in both groups</description>
    <arm_group_label>norepinephrine</arm_group_label>
    <arm_group_label>phenylephrine,</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (normal saline)</intervention_name>
    <arm_group_label>phenylephrine,</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  full term singleton parturients&#xD;
&#xD;
          -  elective cesarean sections&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiac morbidities&#xD;
&#xD;
          -  hypertensive disorders of pregnancy&#xD;
&#xD;
          -  peripartum bleeding&#xD;
&#xD;
          -  body mass index &gt; 35 will be excluded from the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shereen Refaat, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Lecturer of anesthesia Faculty of medicine Cairo university</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tamer M Rook, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Lecturer of anesthesia Faculty of medicine Cairo university</affiliation>
  </overall_official>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>January 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>May 1, 2017</last_update_submitted>
  <last_update_submitted_qc>May 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>ahmed elsakka</investigator_full_name>
    <investigator_title>Principal investigator and lecturer of anesthesia, faculty of medicine cairo university</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>Fentanyl</mesh_term>
    <mesh_term>Bupivacaine</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/NCT03015857
org study id: cesarean sections
nct id: NCT03015857
lead sponsor: 
has dmc: No
Hypotension following spinal anesthesia for cesarean section is a serious problem. In this
      study we investigated the effect of the vasopressors phenylephrine and noradrenaline on
      postspinal hypotension.
On arrival to the operating room, an 18g cannula will be inserted and monitors will be
      applied (electrocardiography - pulse oximetry - non-invasive blood pressure monitor).
      Patients will receive spinal anesthesia with 500 ml rapid crystalloid co-load. Ten milligrams
      heavy bupivacaine in addition to 20 mcg fentanyl will be injected in L3-L4 or L4-L5
      interspace using 25 g spinal needle in the sitting position.

      After spinal block, patients will be randomly allocated into one of two groups:

        -  Phenylephrine group (n=100)

        -  Norepinephrine group (n=100)

      Patients who shows SBP above 140 mmHg or heart rate below 55 bpm after the first vasopressor
      dose will not receive the infusion. The infusion will stop if the SBP was above 140 mmHg or
      if the heart rate was below 55 bpm. Patients will be positioned in the supine position with
      left lateral tilt. Block success will be assessed using pinprick, patients with failed block
      will be excluded from the study. The highest sensory block level will be assessed after 5
      minutes from intrathecal injection. Co-hydration will be continued till maximum of 1.5
      litres.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of post spinal hypotension (PSH) 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)
time frame: 2 hours
measure: systolic and diastolic blood pressures measured in mm Hg
time frame: 2 hours
measure: heart rate measured in beats per minute
time frame: 2 hours
measure: nausea and vomiting measured in number of attacks
time frame: 2 hours
arm group label: phenylephrine,
arm group type: Active Comparator
description: - Phenylephrine group (n=100): will receive 100 mcg phenylephrine as a single bolus just after intrathecal injection of 10 mg bupivacaine plus 20 mcg fentanyl. The dose will be diluted in 5 mL and given over seconds. A continuous infusion with placebo (normal saline) will start after the first bolus.
arm group label: norepinephrine
arm group type: Active Comparator
description: - Norepinephrine group (n=100): will receive bolus of norepinephrine (10 mcg) directly after spinal block using 10 mg bupivacaine plus 20 mcg fentantanyl followed by continuous infusion of norepinephrine with a rate of 0.1 mcg/kg/min till delivery of the fetus.
intervention type: Drug
intervention name: phenylephrine
description: - phenylephrine; a vasopressor drug given to prevent post spinal hypotension
arm group label: phenylephrine,
intervention type: Drug
intervention name: Norepinephrine
description: - norepinephrine; a vasopressor drug given to prevent post spinal hypotension
arm group label: norepinephrine
intervention type: Drug
intervention name: Bupivacaine
description: intrathecal bupivacaine 10 mg will be given in both groups
arm group label: norepinephrine
arm group label: phenylephrine,
intervention type: Drug
intervention name: Fentanyl
description: intrathecal fentanyl 20 mcg will be given in both groups
arm group label: norepinephrine
arm group label: phenylephrine,
intervention type: Drug
intervention name: Placebo (normal saline)
arm group label: phenylephrine,
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Shereen Refaat, M.D.
role: Study Chair
affiliation: Lecturer of anesthesia Faculty of medicine Cairo university
last name: Tamer M Rook, M.D.
role: Study Chair
affiliation: Lecturer of anesthesia Faculty of medicine Cairo university
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: ahmed elsakka
investigator title: Principal investigator and lecturer of anesthesia, faculty of medicine cairo university
mesh term: Hypotension
mesh term: Phenylephrine
mesh term: Oxymetazoline
mesh term: Norepinephrine
mesh term: Fentanyl
mesh term: Bupivacaine
sharing ipd: Undecided