<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/NCT02979405</url>
  </required_header>
  <id_info>
    <org_study_id>UIS 2016</org_study_id>
    <nct_id>NCT02979405</nct_id>
  </id_info>
  <brief_title>Effectiveness of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery</brief_title>
  <official_title>Effectivenes of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery: a Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Industrial de Santander</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Industrial de Santander</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypotension in patients who are taken to surgery, is a very frequent complication, when the&#xD;
      spinal anesthetical technique is used, associating this with significant adverse effects that&#xD;
      can lead to morbidity specially in the obstetric patient. The objective of the study is&#xD;
      determine if the phenylephrine used of prophylactic form, achieved to prevent the appearance&#xD;
      of hypotension in obstetric patients led to Caesarea under spinal anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Worldwide, the caesarean section is one of the surgical procedures most frequently performed,&#xD;
      representing a challenge to the anesthesiologist, who must administer anesthesia to the&#xD;
      mother with minimal effects in the newborn. For this reason, spinal anesthesia emerges as an&#xD;
      important option in the management of the obstetrical patient who is going to be taken to&#xD;
      Caesarea. The hypotension, is one of the most frequent events adverse associated to this&#xD;
      technical anesthetic, represented a risk of complications both, in the mother as in the&#xD;
      fetus, by this reason the anesthesiologist must implement different strategies to treat it&#xD;
      when this be present. From there arises the necessity of establishing if the phenylephrine, a&#xD;
      drug used to treat hypotension, when is administed prophylactically, allows to avoid this&#xD;
      effect. We designed a randomized clinical trial in elderly patients over 18 years who are&#xD;
      taken to Caesarea, where they formed two groups of patients, one that will administer a&#xD;
      prophylactic infusion of phenylephrine compared with placebo, assessing the incidence of&#xD;
      hypotension in the two groups and the adverse events most commonly associated with this.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2017</start_date>
  <completion_date type="Actual">February 21, 2017</completion_date>
  <primary_completion_date type="Actual">February 20, 2017</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hypotension</measure>
    <time_frame>caesarean delivery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>caesarean delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Newborn APGAR</measure>
    <time_frame>Turn off of the newly born: measured to the 1 and 5 minutes from the birth</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Nausea</measure>
    <time_frame>surgical procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Vomiting</measure>
    <time_frame>surgical procedure</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Hypotension Drug-Induced</condition>
  <arm_group>
    <arm_group_label>group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phenylephrine 40 mcg/min, infusion during 5 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline solution 21 cc, infusion during 5 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Phenylephrine</intervention_name>
    <description>prophylactic infusion of phenylephrine 40 mcg/min</description>
    <arm_group_label>group 1</arm_group_label>
    <arm_group_label>group 2</arm_group_label>
    <other_name>prophylactic Phenylephrine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant subjects who are to be delivered to cesarean section under subarachnoid&#xD;
             anesthesia&#xD;
&#xD;
          -  Gestational age &gt;37 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pregnant subjects with:&#xD;
&#xD;
          -  Hipertensive disorders in pregnancy&#xD;
&#xD;
          -  Acute fetal distress&#xD;
&#xD;
          -  Evidence of placental dysfunction&#xD;
&#xD;
          -  History of cardiovascular or cerebrovascular diseases&#xD;
&#xD;
          -  hypersensitivity to phenylephrine&#xD;
&#xD;
          -  Rejection of the patient&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hector Meléndez, Dr</last_name>
    <role>Study Director</role>
    <affiliation>Universidad Industrial de Santander</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinic materno infaltil San Luis</name>
      <address>
        <city>Bucaramanga</city>
        <state>Santander</state>
        <zip>68003</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>February 22, 2017</last_update_submitted>
  <last_update_submitted_qc>February 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Industrial de Santander</investigator_affiliation>
    <investigator_full_name>Nelly Johanna Puentes Vega</investigator_full_name>
    <investigator_title>Principal investigator</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>
  </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/NCT02979405
org study id: UIS 2016
nct id: NCT02979405
lead sponsor: 
has dmc: Yes
Hypotension in patients who are taken to surgery, is a very frequent complication, when the
      spinal anesthetical technique is used, associating this with significant adverse effects that
      can lead to morbidity specially in the obstetric patient. The objective of the study is
      determine if the phenylephrine used of prophylactic form, achieved to prevent the appearance
      of hypotension in obstetric patients led to Caesarea under spinal anesthesia.
Worldwide, the caesarean section is one of the surgical procedures most frequently performed,
      representing a challenge to the anesthesiologist, who must administer anesthesia to the
      mother with minimal effects in the newborn. For this reason, spinal anesthesia emerges as an
      important option in the management of the obstetrical patient who is going to be taken to
      Caesarea. The hypotension, is one of the most frequent events adverse associated to this
      technical anesthetic, represented a risk of complications both, in the mother as in the
      fetus, by this reason the anesthesiologist must implement different strategies to treat it
      when this be present. From there arises the necessity of establishing if the phenylephrine, a
      drug used to treat hypotension, when is administed prophylactically, allows to avoid this
      effect. We designed a randomized clinical trial in elderly patients over 18 years who are
      taken to Caesarea, where they formed two groups of patients, one that will administer a
      prophylactic infusion of phenylephrine compared with placebo, assessing the incidence of
      hypotension in the two groups and the adverse events most commonly associated with this.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: Hypotension
time frame: caesarean delivery
measure: heart rate
time frame: caesarean delivery
measure: Newborn APGAR
time frame: Turn off of the newly born: measured to the 1 and 5 minutes from the birth
measure: Nausea
time frame: surgical procedure
measure: Vomiting
time frame: surgical procedure
arm group label: group 1
arm group type: Experimental
description: Phenylephrine 40 mcg/min, infusion during 5 minutes
arm group label: group 2
arm group type: Placebo Comparator
description: Saline solution 21 cc, infusion during 5 minutes
intervention type: Drug
intervention name: Phenylephrine
description: prophylactic infusion of phenylephrine 40 mcg/min
arm group label: group 1
arm group label: group 2
other name: prophylactic Phenylephrine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hector Meléndez, Dr
role: Study Director
affiliation: Universidad Industrial de Santander
facility: 
country: Colombia
responsible party type: Principal Investigator
investigator affiliation: Universidad Industrial de Santander
investigator full name: Nelly Johanna Puentes Vega
investigator title: Principal investigator
mesh term: Hypotension
mesh term: Phenylephrine
mesh term: Oxymetazoline
sharing ipd: No