<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/NCT04406051</url>
  </required_header>
  <id_info>
    <org_study_id>nor-cryst vs. nor-coll</org_study_id>
    <nct_id>NCT04406051</nct_id>
  </id_info>
  <brief_title>Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion.</brief_title>
  <acronym>annie-manos</acronym>
  <official_title>Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion. Does Time and Type of Administered Fluids Matter?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aretaieion University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alexandra Hospital, Athens, Greece</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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 randomized study aiming at investigating the combination of a norepinephrine&#xD;
      infusion and colloid preloading versus the combination of a norepinephrine infusion and&#xD;
      crystalloid co-loading for the prevention of maternal hypotension during elective cesarean&#xD;
      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. Recently, noradrenaline has been&#xD;
      shown to be effective in maintaining blood pressure in obstetric patients. Another technique&#xD;
      widely used to prevent hypotension is fluid administration. Current evidence suggests that&#xD;
      the combination of fluid administration and vasoconstrictive medications should be the main&#xD;
      strategy for prevention and management of hypotension accompanying neuraxial anesthesia&#xD;
      procedures during cesarean section. Research is still underway in relation to the most&#xD;
      appropriate timing for fluid administration, the most appropriate fluid volume as well as the&#xD;
      type of fluid that should be administered. However, preloading of crystalloids seems to be&#xD;
      inefficient as a sole strategy, while co-loading of colloids is more effective than&#xD;
      co-loading of crystalloids for prevention of hypotension in the parturient. On the other&#xD;
      hand, preloading and co-loading of colloids seem to be of equal effectiveness. Literature is&#xD;
      rather scarce regarding the comparison of colloid preloading and crystalloid co-loading.&#xD;
&#xD;
      The aim of this randomized study will be to investigate the combination of a norepinephrine&#xD;
      infusion and colloid preloading versus the combination of a norepinephrine infusion and&#xD;
      crystalloid co-loading for the prevention of maternal hypotension during elective cesarean&#xD;
      section.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 26, 2020</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <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>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>incidence of bradycardia</measure>
    <time_frame>intraoperative</time_frame>
    <description>any incidence of maternal bradycardia (heart rate&lt;60/min) 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 min</measure>
    <time_frame>1 min post delivery</time_frame>
    <description>Neonatal Apgar score will be recorded at 1 min 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 min</measure>
    <time_frame>5 min post delivery</time_frame>
    <description>Neonatal Apgar score will be recorded at 5 min 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 min 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 min post delivery</time_frame>
    <description>glucose will be measured in the cord blood gas sample taken immediately post-delivery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Hypotension</condition>
  <condition>Obstetric Anesthesia Problems</condition>
  <condition>Cesarean Section Complications</condition>
  <condition>Hypotensive</condition>
  <condition>Vasoconstriction</condition>
  <arm_group>
    <arm_group_label>norepinephrine infusion and colloid preloading (NOR-COL)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive colloid preloading (5 mL/kg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>norepinephrine infusion and crystalloid co-loading (NOR-CRYS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive crystalloid co-loading (10 mL/kg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>norepinephrine infusion and colloid preloading (NOR-COL)</intervention_name>
    <description>in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 5 mL/kg of colloid infusion prior to the initiation of spinal anesthesia</description>
    <arm_group_label>norepinephrine infusion and colloid preloading (NOR-COL)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>norepinephrine infusion and crystalloid co-loading (NOR-CRYST)</intervention_name>
    <description>in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 10 mL/kg of crystalloid infusion simultaneously with the initiation of spinal anesthesia</description>
    <arm_group_label>norepinephrine infusion and crystalloid co-loading (NOR-CRYS)</arm_group_label>
  </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>
  <overall_official>
    <last_name>Emmanouil Stamatakis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandra General Hospital of Athens</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sofia Hadzilia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandra General Hospital of Athens</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dimitrios Valsamidis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandra General Hospital of Athens</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Konstantina Kalopita, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandra General Hospital of Athens</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>
    <facility>
      <name>Alexandra General Hospital of Athens</name>
      <address>
        <city>Athens</city>
        <zip>11528</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Afolabi BB, Lesi FE. Regional versus general anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Oct 17;10:CD004350. doi: 10.1002/14651858.CD004350.pub3.</citation>
    <PMID>23076903</PMID>
  </reference>
  <reference>
    <citation>Klohr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23.</citation>
    <PMID>20455872</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>Banerjee A, Stocche RM, Angle P, Halpern SH. Preload or coload for spinal anesthesia for elective Cesarean delivery: a meta-analysis. Can J Anaesth. 2010 Jan;57(1):24-31. doi: 10.1007/s12630-009-9206-7. Epub 2009 Oct 27.</citation>
    <PMID>19859776</PMID>
  </reference>
  <reference>
    <citation>Mercier FJ. Fluid loading for cesarean delivery under spinal anesthesia: have we studied all the options? Anesth Analg. 2011 Oct;113(4):677-80. doi: 10.1213/ANE.0b013e3182245af4. No abstract available.</citation>
    <PMID>21948275</PMID>
  </reference>
  <reference>
    <citation>Li L, Zhang Y, Tan Y, Xu S. Colloid or crystalloid solution on maternal and neonatal hemodynamics for cesarean section: a meta-analysis of randomized controlled trials. J Obstet Gynaecol Res. 2013 May;39(5):932-41. doi: 10.1111/jog.12001. Epub 2013 Feb 4.</citation>
    <PMID>23379937</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>May 24, 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>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/NCT04406051
org study id: nor-cryst vs. nor-coll
nct id: NCT04406051
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This will be a randomized study aiming at investigating the combination of a norepinephrine
      infusion and colloid preloading versus the combination of a norepinephrine infusion and
      crystalloid co-loading for the prevention of maternal hypotension during 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. Recently, noradrenaline has been
      shown to be effective in maintaining blood pressure in obstetric patients. Another technique
      widely used to prevent hypotension is fluid administration. Current evidence suggests that
      the combination of fluid administration and vasoconstrictive medications should be the main
      strategy for prevention and management of hypotension accompanying neuraxial anesthesia
      procedures during cesarean section. Research is still underway in relation to the most
      appropriate timing for fluid administration, the most appropriate fluid volume as well as the
      type of fluid that should be administered. However, preloading of crystalloids seems to be
      inefficient as a sole strategy, while co-loading of colloids is more effective than
      co-loading of crystalloids for prevention of hypotension in the parturient. On the other
      hand, preloading and co-loading of colloids seem to be of equal effectiveness. Literature is
      rather scarce regarding the comparison of colloid preloading and crystalloid co-loading.

      The aim of this randomized study will be to investigate the combination of a norepinephrine
      infusion and colloid preloading versus the combination of a norepinephrine infusion and
      crystalloid co-loading for the prevention of maternal hypotension during elective cesarean
      section.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
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: 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: incidence of bradycardia
time frame: intraoperative
description: any incidence of maternal bradycardia (heart rate<60/min) 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 min
time frame: 1 min post delivery
description: Neonatal Apgar score will be recorded at 1 min 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 min
time frame: 5 min post delivery
description: Neonatal Apgar score will be recorded at 5 min 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 min post delivery
description: fetal cord blood analysis will be performed immediately post-delivery
measure: glucose in neonatal blood
time frame: 1 min post delivery
description: glucose will be measured in the cord blood gas sample taken immediately post-delivery
arm group label: norepinephrine infusion and colloid preloading (NOR-COL)
arm group type: Active Comparator
description: in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive colloid preloading (5 mL/kg)
arm group label: norepinephrine infusion and crystalloid co-loading (NOR-CRYS)
arm group type: Active Comparator
description: in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive crystalloid co-loading (10 mL/kg)
intervention type: Procedure
intervention name: norepinephrine infusion and colloid preloading (NOR-COL)
description: in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 5 mL/kg of colloid infusion prior to the initiation of spinal anesthesia
arm group label: norepinephrine infusion and colloid preloading (NOR-COL)
intervention type: Procedure
intervention name: norepinephrine infusion and crystalloid co-loading (NOR-CRYST)
description: in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 10 mL/kg of crystalloid infusion simultaneously with the initiation of spinal anesthesia
arm group label: norepinephrine infusion and crystalloid co-loading (NOR-CRYS)
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
last name: Emmanouil Stamatakis, PhD
role: Principal Investigator
affiliation: Alexandra General Hospital of Athens
last name: Sofia Hadzilia, MD
role: Principal Investigator
affiliation: Alexandra General Hospital of Athens
last name: Dimitrios Valsamidis, MD
role: Principal Investigator
affiliation: Alexandra General Hospital of Athens
last name: Konstantina Kalopita, MD
role: Principal Investigator
affiliation: Alexandra General Hospital of Athens
facility: 
facility: 
country: Greece
citation: Afolabi BB, Lesi FE. Regional versus general anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Oct 17;10:CD004350. doi: 10.1002/14651858.CD004350.pub3.
PMID: 23076903
citation: Klohr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23.
PMID: 20455872
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: Banerjee A, Stocche RM, Angle P, Halpern SH. Preload or coload for spinal anesthesia for elective Cesarean delivery: a meta-analysis. Can J Anaesth. 2010 Jan;57(1):24-31. doi: 10.1007/s12630-009-9206-7. Epub 2009 Oct 27.
PMID: 19859776
citation: Mercier FJ. Fluid loading for cesarean delivery under spinal anesthesia: have we studied all the options? Anesth Analg. 2011 Oct;113(4):677-80. doi: 10.1213/ANE.0b013e3182245af4. No abstract available.
PMID: 21948275
citation: Li L, Zhang Y, Tan Y, Xu S. Colloid or crystalloid solution on maternal and neonatal hemodynamics for cesarean section: a meta-analysis of randomized controlled trials. J Obstet Gynaecol Res. 2013 May;39(5):932-41. doi: 10.1111/jog.12001. Epub 2013 Feb 4.
PMID: 23379937
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: Norepinephrine
sharing ipd: No