<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/NCT04404946</url>
  </required_header>
  <id_info>
    <org_study_id>196/25-02-2020</org_study_id>
    <nct_id>NCT04404946</nct_id>
  </id_info>
  <brief_title>Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Hypotension During Cesarean Section</brief_title>
  <acronym>annie-zoe</acronym>
  <official_title>Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Postspinal Hypotension During Elective Cesarean Section. A Comparative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aretaieion University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aretaieion University Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      This will be a double-blind randomized study, aiming at investigating a fixed rate&#xD;
      phenylephrine infusion versus a fixed rate norepinephrine infusion versus placebo in&#xD;
      combination with co-hydration with colloids for the prevention of maternal hypotension in&#xD;
      elective cesarean section&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric&#xD;
      anesthesia practice, with a definitive superiority as compared to general anesthesia, since,&#xD;
      by their use, serious complications involving the airway can be avoided.Spinal anesthesia has&#xD;
      become the favorable technique for both elective and emergency cesarean section due to a&#xD;
      quick and predictable onset of action, however, it can be frequently complicated by&#xD;
      hypotension, with incidence exceeding 80% occasionally.&#xD;
&#xD;
      The aim of the current randomized controlled double-blinded trial was to compare the effect&#xD;
      of a fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine infusion versus&#xD;
      placebo in parturients subjected to elective cesarean section under combined spinal-epidural&#xD;
      anesthesia. All parturients will also receive colloid co-hydration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 23, 2020</start_date>
  <completion_date type="Actual">May 31, 2021</completion_date>
  <primary_completion_date type="Actual">May 31, 2021</primary_completion_date>
  <phase>N/A</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of bradycardia</measure>
    <time_frame>intraoperative</time_frame>
    <description>any incidence of maternal bradycardia (heart rate&lt;60/min) will be recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of hypotension</measure>
    <time_frame>intraoperative</time_frame>
    <description>any occurence of hypotension (systolic blood pressure&lt;80% of baseline) throughout the operation will be recorded</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>need for vasoconstrictor</measure>
    <time_frame>intraoperative</time_frame>
    <description>any need for vasoconstrictor during the operation will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>type of vasoconstrictor administered</measure>
    <time_frame>intraoperative</time_frame>
    <description>phenylephrine versus ephedrine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of bolus doses of vasoconstrictor administered</measure>
    <time_frame>intraoperative</time_frame>
    <description>number of interventions to maintain systolic blood pressure within the set limits will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total dose of vasoconstrictor administered</measure>
    <time_frame>intraoperative</time_frame>
    <description>total dose in mg for ephedrine or μg for phenylephrine administered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of hypertension</measure>
    <time_frame>intraoperative</time_frame>
    <description>any incidence of systolic blood pressure&gt;120% of baseline will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>need for atropine</measure>
    <time_frame>intraoperative</time_frame>
    <description>any need for atropine during the operation because of bradycardia will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>modification or cessation of the infusion</measure>
    <time_frame>intraoperative</time_frame>
    <description>any requirement for modification or cessation of the infusion due to reactive hypertension or bradycardia will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of nausea/vomiting</measure>
    <time_frame>intraoperative</time_frame>
    <description>any occurence of nausea and/or vomiting during the operation will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Apgar score at 1 minutes</measure>
    <time_frame>1 minute post delivery</time_frame>
    <description>Neonatal Apgar score will be recorded at 1 minutes after delivery. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Apgar score at 5 minutes</measure>
    <time_frame>5 minutes post delivery</time_frame>
    <description>Neonatal Apgar score will be recorded at 5 minutes after delivery. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neonatal blood gases</measure>
    <time_frame>1 minute post delivery</time_frame>
    <description>fetal cord blood analysis will be performed immediately post-delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>glucose in neonatal blood</measure>
    <time_frame>1 minute post delivery</time_frame>
    <description>glucose will be measured in the cord blood gas sample taken immediately post-delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adrenaline in neonatal blood</measure>
    <time_frame>5 minutes post delivery</time_frame>
    <description>an amount of the umbilical artery cord blood sampled from every neonate will be sent for lab measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>noradrenaline in neonatal blood</measure>
    <time_frame>5 minutes post delivery</time_frame>
    <description>an amount of the umbilical artery cord blood sampled from every neonate will be sent for lab measurements</description>
  </secondary_outcome>
  <other_outcome>
    <measure>cardiac output</measure>
    <time_frame>intraoperative</time_frame>
    <description>cardiac output via non-invasive device (Nexfin) will be measured intraoperatively</description>
  </other_outcome>
  <other_outcome>
    <measure>stroke volume</measure>
    <time_frame>intraoperative</time_frame>
    <description>stroke volume via non-invasive device (Nexfin) will be measured intraoperatively</description>
  </other_outcome>
  <other_outcome>
    <measure>systemic vascular resistance</measure>
    <time_frame>intraoperative</time_frame>
    <description>systemic vascular resistance via non-invasive device (Nexfin) will be measured intraoperatively</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Hypotension Symptomatic</condition>
  <condition>Vasoconstriction</condition>
  <condition>Cesarean Section Complications</condition>
  <condition>Obstetric Anesthesia Problems</condition>
  <arm_group>
    <arm_group_label>phenylephrine infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>fixed-rate phenylephrine infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>norepinephrine infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>fixed-rate norepinephrine infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo infusion</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>normal saline infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>phenylephrine infusion</intervention_name>
    <description>in parturients allocated to the phenylephrine group, a phenylephrine infusion will be started as soon as spinal anesthesia is initiated</description>
    <arm_group_label>phenylephrine infusion</arm_group_label>
    <other_name>medication used for blood pressure maintenance</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>norepinephrine infusion</intervention_name>
    <description>in parturients allocated to the norepinephrine group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated</description>
    <arm_group_label>norepinephrine infusion</arm_group_label>
    <other_name>medication used for blood pressure maintenance</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo infusion</intervention_name>
    <description>in parturients allocated to the placebo group, a normal saline infusion will be started as soon as spinal anesthesia is initiated</description>
    <arm_group_label>placebo infusion</arm_group_label>
    <other_name>medication used for blood pressure maintenance</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult parturients, American Society of Anesthesiologists (ASA) I-II,&#xD;
&#xD;
          -  singleton gestation&gt;37 weeks&#xD;
&#xD;
          -  elective cesarean section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt;40 kg/m2&#xD;
&#xD;
          -  Body weight &lt;50 kg&#xD;
&#xD;
          -  Body weight&gt;100 kg&#xD;
&#xD;
          -  height&lt;150 cm&#xD;
&#xD;
          -  height&gt;180 cm&#xD;
&#xD;
          -  multiple gestation&#xD;
&#xD;
          -  fetal abnormality&#xD;
&#xD;
          -  fetal distress&#xD;
&#xD;
          -  active labor&#xD;
&#xD;
          -  cardiac disease&#xD;
&#xD;
          -  pregnancy-induced hypertension&#xD;
&#xD;
          -  thrombocytopenia&#xD;
&#xD;
          -  coagulation abnormalities&#xD;
&#xD;
          -  use of antihypertensive medication during pregnancy&#xD;
&#xD;
          -  communication or language barriers&#xD;
&#xD;
          -  lack of informed consent&#xD;
&#xD;
          -  contraindication for regional anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>48 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kassiani Theodoraki, PhD, DESA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aretaieion University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aretaieion University Hospital</name>
      <address>
        <city>Athens</city>
        <zip>115 28</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Langesaeter E, Dyer RA. Maternal haemodynamic changes during spinal anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2011 Jun;24(3):242-8. doi: 10.1097/ACO.0b013e32834588c5.</citation>
    <PMID>21415724</PMID>
  </reference>
  <reference>
    <citation>Ngan Kee WD. Prevention of maternal hypotension after regional anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2010 Jun;23(3):304-9. doi: 10.1097/ACO.0b013e328337ffc6.</citation>
    <PMID>20173633</PMID>
  </reference>
  <reference>
    <citation>Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.</citation>
    <PMID>29090733</PMID>
  </reference>
  <reference>
    <citation>Mets B. Should Norepinephrine, Rather than Phenylephrine, Be Considered the Primary Vasopressor in Anesthetic Practice? Anesth Analg. 2016 May;122(5):1707-14. doi: 10.1213/ANE.0000000000001239. No abstract available. Erratum In: Anesth Analg. 2016 Aug;123(2):522.</citation>
    <PMID>27101504</PMID>
  </reference>
  <reference>
    <citation>Carvalho B, Dyer RA. Norepinephrine for Spinal Hypotension during Cesarean Delivery: Another Paradigm Shift? Anesthesiology. 2015 Apr;122(4):728-30. doi: 10.1097/ALN.0000000000000602. No abstract available.</citation>
    <PMID>25654435</PMID>
  </reference>
  <reference>
    <citation>Sen I, Hirachan R, Bhardwaj N, Jain K, Suri V, Kumar P. Colloid cohydration and variable rate phenylephrine infusion effectively prevents postspinal hypotension in elective Cesarean deliveries. J Anaesthesiol Clin Pharmacol. 2013 Jul;29(3):348-55. doi: 10.4103/0970-9185.117106.</citation>
    <PMID>24106360</PMID>
  </reference>
  <reference>
    <citation>Gunusen I, Karaman S, Ertugrul V, Firat V. Effects of fluid preload (crystalloid or colloid) compared with crystalloid co-load plus ephedrine infusion on hypotension and neonatal outcome during spinal anaesthesia for caesarean delivery. Anaesth Intensive Care. 2010 Jul;38(4):647-53. doi: 10.1177/0310057X1003800337.</citation>
    <PMID>20715726</PMID>
  </reference>
  <reference>
    <citation>Kulkarni KR, Naik AG, Deshpande SG. Evaluation of antihypotensive techniques for cesarean section under spinal anesthesia: Rapid crystalloid hydration versus intravenous ephedrine. Anesth Essays Res. 2016 Sep-Dec;10(3):637-642. doi: 10.4103/0259-1162.191118.</citation>
    <PMID>27746565</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>June 13, 2021</last_update_submitted>
  <last_update_submitted_qc>June 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aretaieion University Hospital</investigator_affiliation>
    <investigator_full_name>Dr Kassiani Theodoraki</investigator_full_name>
    <investigator_title>Professor of Anesthesiology</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>
  </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/NCT04404946
org study id: 196/25-02-2020
nct id: NCT04404946
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This will be a double-blind randomized study, aiming at investigating a fixed rate
      phenylephrine infusion versus a fixed rate norepinephrine infusion versus placebo in
      combination with co-hydration with colloids for the prevention of maternal hypotension in
      elective cesarean section
Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric
      anesthesia practice, with a definitive superiority as compared to general anesthesia, since,
      by their use, serious complications involving the airway can be avoided.Spinal anesthesia has
      become the favorable technique for both elective and emergency cesarean section due to a
      quick and predictable onset of action, however, it can be frequently complicated by
      hypotension, with incidence exceeding 80% occasionally.

      The aim of the current randomized controlled double-blinded trial was to compare the effect
      of a fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine infusion versus
      placebo in parturients subjected to elective cesarean section under combined spinal-epidural
      anesthesia. All parturients will also receive colloid co-hydration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: incidence of bradycardia
time frame: intraoperative
description: any incidence of maternal bradycardia (heart rate<60/min) will be recorded
measure: incidence of hypotension
time frame: intraoperative
description: any occurence of hypotension (systolic blood pressure<80% of baseline) throughout the operation will be recorded
measure: need for vasoconstrictor
time frame: intraoperative
description: any need for vasoconstrictor during the operation will be recorded
measure: type of vasoconstrictor administered
time frame: intraoperative
description: phenylephrine versus ephedrine
measure: number of bolus doses of vasoconstrictor administered
time frame: intraoperative
description: number of interventions to maintain systolic blood pressure within the set limits will be recorded
measure: total dose of vasoconstrictor administered
time frame: intraoperative
description: total dose in mg for ephedrine or μg for phenylephrine administered
measure: incidence of hypertension
time frame: intraoperative
description: any incidence of systolic blood pressure>120% of baseline will be recorded
measure: need for atropine
time frame: intraoperative
description: any need for atropine during the operation because of bradycardia will be recorded
measure: modification or cessation of the infusion
time frame: intraoperative
description: any requirement for modification or cessation of the infusion due to reactive hypertension or bradycardia will be recorded
measure: incidence of nausea/vomiting
time frame: intraoperative
description: any occurence of nausea and/or vomiting during the operation will be recorded
measure: Neonatal Apgar score at 1 minutes
time frame: 1 minute post delivery
description: Neonatal Apgar score will be recorded at 1 minutes after delivery. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.
measure: Neonatal Apgar score at 5 minutes
time frame: 5 minutes post delivery
description: Neonatal Apgar score will be recorded at 5 minutes after delivery. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.
measure: neonatal blood gases
time frame: 1 minute post delivery
description: fetal cord blood analysis will be performed immediately post-delivery
measure: glucose in neonatal blood
time frame: 1 minute post delivery
description: glucose will be measured in the cord blood gas sample taken immediately post-delivery
measure: adrenaline in neonatal blood
time frame: 5 minutes post delivery
description: an amount of the umbilical artery cord blood sampled from every neonate will be sent for lab measurements
measure: noradrenaline in neonatal blood
time frame: 5 minutes post delivery
description: an amount of the umbilical artery cord blood sampled from every neonate will be sent for lab measurements
measure: cardiac output
time frame: intraoperative
description: cardiac output via non-invasive device (Nexfin) will be measured intraoperatively
measure: stroke volume
time frame: intraoperative
description: stroke volume via non-invasive device (Nexfin) will be measured intraoperatively
measure: systemic vascular resistance
time frame: intraoperative
description: systemic vascular resistance via non-invasive device (Nexfin) will be measured intraoperatively
arm group label: phenylephrine infusion
arm group type: Active Comparator
description: fixed-rate phenylephrine infusion
arm group label: norepinephrine infusion
arm group type: Active Comparator
description: fixed-rate norepinephrine infusion
arm group label: placebo infusion
arm group type: Placebo Comparator
description: normal saline infusion
intervention type: Other
intervention name: phenylephrine infusion
description: in parturients allocated to the phenylephrine group, a phenylephrine infusion will be started as soon as spinal anesthesia is initiated
arm group label: phenylephrine infusion
other name: medication used for blood pressure maintenance
intervention type: Other
intervention name: norepinephrine infusion
description: in parturients allocated to the norepinephrine group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated
arm group label: norepinephrine infusion
other name: medication used for blood pressure maintenance
intervention type: Other
intervention name: placebo infusion
description: in parturients allocated to the placebo group, a normal saline infusion will be started as soon as spinal anesthesia is initiated
arm group label: placebo infusion
other name: medication used for blood pressure maintenance
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 48 Years
healthy volunteers: No
last name: Kassiani Theodoraki, PhD, DESA
role: Principal Investigator
affiliation: Aretaieion University Hospital
facility: 
country: Greece
citation: Langesaeter E, Dyer RA. Maternal haemodynamic changes during spinal anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2011 Jun;24(3):242-8. doi: 10.1097/ACO.0b013e32834588c5.
PMID: 21415724
citation: Ngan Kee WD. Prevention of maternal hypotension after regional anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2010 Jun;23(3):304-9. doi: 10.1097/ACO.0b013e328337ffc6.
PMID: 20173633
citation: Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.
PMID: 29090733
citation: Mets B. Should Norepinephrine, Rather than Phenylephrine, Be Considered the Primary Vasopressor in Anesthetic Practice? Anesth Analg. 2016 May;122(5):1707-14. doi: 10.1213/ANE.0000000000001239. No abstract available. Erratum In: Anesth Analg. 2016 Aug;123(2):522.
PMID: 27101504
citation: Carvalho B, Dyer RA. Norepinephrine for Spinal Hypotension during Cesarean Delivery: Another Paradigm Shift? Anesthesiology. 2015 Apr;122(4):728-30. doi: 10.1097/ALN.0000000000000602. No abstract available.
PMID: 25654435
citation: Sen I, Hirachan R, Bhardwaj N, Jain K, Suri V, Kumar P. Colloid cohydration and variable rate phenylephrine infusion effectively prevents postspinal hypotension in elective Cesarean deliveries. J Anaesthesiol Clin Pharmacol. 2013 Jul;29(3):348-55. doi: 10.4103/0970-9185.117106.
PMID: 24106360
citation: Gunusen I, Karaman S, Ertugrul V, Firat V. Effects of fluid preload (crystalloid or colloid) compared with crystalloid co-load plus ephedrine infusion on hypotension and neonatal outcome during spinal anaesthesia for caesarean delivery. Anaesth Intensive Care. 2010 Jul;38(4):647-53. doi: 10.1177/0310057X1003800337.
PMID: 20715726
citation: Kulkarni KR, Naik AG, Deshpande SG. Evaluation of antihypotensive techniques for cesarean section under spinal anesthesia: Rapid crystalloid hydration versus intravenous ephedrine. Anesth Essays Res. 2016 Sep-Dec;10(3):637-642. doi: 10.4103/0259-1162.191118.
PMID: 27746565
responsible party type: Principal Investigator
investigator affiliation: Aretaieion University Hospital
investigator full name: Dr Kassiani Theodoraki
investigator title: Professor of Anesthesiology
mesh term: Hypotension
mesh term: Phenylephrine
mesh term: Oxymetazoline
mesh term: Norepinephrine
sharing ipd: No