<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/NCT04450667</url>
  </required_header>
  <id_info>
    <org_study_id>CHUB_MATHYPOTA</org_study_id>
    <nct_id>NCT04450667</nct_id>
  </id_info>
  <brief_title>Post Spinal Anesthesia Hypotension and Preoperative Hydration</brief_title>
  <official_title>Impact of Preoperative Oral Rehydration on the Incidence of Spinal Anesthesia-induced Hypotension for Scheduled Cesarean Section.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brugmann University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brugmann 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>
      Study of the impact of preoperative oral rehydration on the incidence of spinal&#xD;
      anesthesia-induced hypotension for scheduled cesarean section.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      What is already known ? Arterial hypotension is one of the most common complications&#xD;
      following spinal anesthesia (60%). Several measures have been studied to prevent this&#xD;
      hypotension, such as intravenous vascular filling (preloading, coloading), using different&#xD;
      filling fluids (colloids vs crystalloids), preventive administration of vasopressors,&#xD;
      reduction of doses and volumes administered in spinal anesthesia.&#xD;
&#xD;
      Only one study has evaluated the impact of oral rehydration on hypotension after spinal&#xD;
      anesthesia.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      The investigatord wish to demonstrate that an oral rehydration 2 hours before surgery,&#xD;
      reduces by 50% the incidence of hypotension and / or the use of vasopressors, after spinal&#xD;
      anesthesia&#xD;
&#xD;
      Primary outcome:&#xD;
&#xD;
      Decrease in the incidence of hypotension and / or use of vasopressor agents by 50% in the&#xD;
      &quot;rehydration&quot; group compared to the &quot;fasting&quot; group.&#xD;
&#xD;
      Secondary outcomes:&#xD;
&#xD;
      Reduced incidence of nausea / vomiting side effects, effect on umbilical pH, APGAR score,&#xD;
      patient satisfaction&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Interventional clinical study. Monocentric, single-blind, randomized, single-blind,&#xD;
      controlled trial with 2 groups of 50 patients.&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
      Patients ≥ 18 years old Scheduled for a scheduled cesarean, under spinal anesthesia Signature&#xD;
      of informed consent Single pregnancy of ≥ 36 weeks 150 cm &lt;height &lt;180 cm 50 kg &lt;weight &lt;100&#xD;
      kg&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
      Patient's refusal Contraindication to spinal anesthesia Allergy to a product used for&#xD;
      anesthesia Age &lt; 18 Known or pregnancy-related hypertension Gestational diabetes with insulin&#xD;
      or pre-existing diabetes with insulin Total language barrier without possibility of&#xD;
      translation ASA ≥ 3&#xD;
&#xD;
      Purpose of the study:&#xD;
&#xD;
      The purpose of this study is to show that oral rehydration 2 hours before the induction of&#xD;
      anesthesia reduces the incidence of spinal anesthesia-induced hypotension.&#xD;
&#xD;
      The primary hypothesis is that the oral intake of 400 ml of clear liquids (in the form of a&#xD;
      standardized carbohydrate solution, NutriciaPreop®) would reduce the hypovolemia related to&#xD;
      the preoperative fasting period, and thus reduce the risk of hypotension following the&#xD;
      installation of the block.&#xD;
&#xD;
      Primary outcome:&#xD;
&#xD;
      Decrease the incidence of maternal hypotension and / or the use of vasoactive agents in the&#xD;
      &quot;rehydration&quot; group by 50%. The blood pressure will be measured by pneumatic cuff, on the&#xD;
      arm, once per minute from the entrance to the operating room until the umbilical cord is&#xD;
      clamped, then once every 5 minutes until the end of the procedure&#xD;
&#xD;
      Secondary outcomes:&#xD;
&#xD;
      Assess the incidence and severity of nausea / vomiting, umbilical pH, APGAR score, patient&#xD;
      comfort (using a visual analog scale graduated from 1 to 10, as well as a satisfaction score&#xD;
      of 1 at 5)&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      This is a prospective interventional, single-blind, unicentric, randomized controlled study&#xD;
      comprising 2 arms of 50 patients.&#xD;
&#xD;
      An &quot;oral rehydration&quot; arm in which patients will receive 400ml NutriciaPreop to drink 2 hours&#xD;
      before anesthesia, and an &quot;fasting&quot; arm in which patients will be fasting since midnight the&#xD;
      day before the intervention. As part of the study, the NutriciaPreop solution is provided&#xD;
      free to patients.&#xD;
&#xD;
      Duration of the study Including 1 patient per working day, the study will last 6 months. We&#xD;
      are considering to set the duration of the study at 9 months.&#xD;
&#xD;
      Materials and methods After recruitment at the anesthesia consultation and signing of the&#xD;
      consent, the randomization is carried out by a member of the medical team not involved in the&#xD;
      planned cesarean section.&#xD;
&#xD;
      Randomization is done by a sealed, opaque envelope containing the group and the instructions&#xD;
      which will be sent to the midwives of the patient's hospital unit.&#xD;
&#xD;
      &quot;Rehydration&quot; arm: 2 boxes of 200 ml Nutricia PreOp to drink 2 hours before anesthesia&#xD;
      &quot;Fasting&quot; arm: patient fasting since midnight the day before the intervention Identical&#xD;
      premedication in the 2 groups: metoclopramide 10mg + ranitidine 50 mg in 50 ml of 0.9% NaCl&#xD;
      IV, as well as 30 ml of sodium citrate per os, on call in the operating room.&#xD;
&#xD;
      Patients will be equipped with 18G venous catheters with obturators to avoid receiving any&#xD;
      maintenance fluid before anesthesia (except premedication) Upon arrival in the operating&#xD;
      room, the team performs the usual safety checklist.&#xD;
&#xD;
      Patient monitoring with ECG scope, PNI cuff, Sp02 The anesthesiologist performs the&#xD;
      standardized spinal anesthesia: 2.2 ml of hyperbaric bupivacaine 0.5% + 0.5 ml of sufentanil&#xD;
      concentration 5 micrograms / ml + 100 microgram of morphine (0.1 ml), for a total volume of&#xD;
      2.8 ml, injected in 30-60 seconds, after reflux of CSF into the L3 / L4 space, previously&#xD;
      identified by ultrasound.&#xD;
&#xD;
      At the start of the injection, the anesthesiologist's assistant loads the venous catheter&#xD;
      with a coloading of 10 ml / kg (ideal weight) of a Hartmann solution (crystalloid balance&#xD;
      containing lactate), then maintenance of 1 ml / kg / h until the umbilical cord is clamped.&#xD;
&#xD;
      For the spinal anesthesia, the patient is placed in a seated position, legs hanging. After&#xD;
      this has been done, patient is placed in supine position, except for those with a body mass&#xD;
      index greater than 35 kG / m2, which are placed in the &quot;beach chair&quot; position. Patients with&#xD;
      a BMI≥35 are installed on a &quot;troop elevation pillow&quot;. In all cases a tilt of 10 ° to the left&#xD;
      will be applied.&#xD;
&#xD;
      Blood pressure measurement per minute on the cuff. Sensory motor block is tested at 5 and 10&#xD;
      min with cold test (ether) and Pricktest. Finally, the surgeon tests before cutting with a&#xD;
      pair of pliers, on the incision area.&#xD;
&#xD;
      Hypotension is defined by a fall of at least 20% in systolic BP compared to the reference&#xD;
      systolic BP and / or the need to use a vasoactive drug.&#xD;
&#xD;
      Correction of any decrease in systolic BP by boli of 6 micrograms of Noradrenaline in IVD.&#xD;
      Possibility of using another vasoactive drug depending on the clinical situation (choice of&#xD;
      responsible anesthesiologist) The analysis will be performed until the umbilical cord is&#xD;
      clamped, then, the anesthesiologist wiil follow the standard cesarean management protocol.&#xD;
&#xD;
      The umbilical pH as well as the APGAR score of the newborn will be noted. The patient's&#xD;
      nausea / vomiting episodes will also be scored and graded on a scale of 0 to 3 with 0 = no&#xD;
      nausea-vomiting, 1: moderate nausea not requiring treatment, 2: moderate nausea responding to&#xD;
      treatment, 3: nausea not responding to treatment or vomiting.&#xD;
&#xD;
      A digital scale for assessing patient satisfaction and well-being will be used once&#xD;
      preoperatively, after signing the consent, and once postoperatively.&#xD;
&#xD;
      Randomization:&#xD;
&#xD;
      Bloc randomization by bloc of 4.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      Based on our incidence of 60% of hypotension, a power analysis shows that 42 patients will be&#xD;
      needed in each group in order de detect a 50% decrease in the incidence of hypotension; with&#xD;
      a power of 80% and alpha fixed at 0.05. 8 patients will be added to each group to compensate&#xD;
      for possible dropouts.&#xD;
&#xD;
      Analysis will be done as &quot;intention to treat&quot;. Incidence of hypotension will be analyzed by a&#xD;
      Chi-square test and the confidence interval will be reported. Secondary outcomes will be&#xD;
      analysed by Chi-square test or Fisher's exact test for discontinuous variable and t-test or&#xD;
      Mann-Whitney-U test for continuous variables.&#xD;
&#xD;
      A P value &lt; 0.05 will be considered as significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Anticipated">September 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2022</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>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hypotension reduction</measure>
    <time_frame>60 minutes</time_frame>
    <description>We aim for a 50% reduction in the incidence of hypotension following spinal anesthesia for scheduled C-section.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>N+/V+</measure>
    <time_frame>60 minutes</time_frame>
    <description>Incidence of nausea and/or vomiting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Umbilical pH</measure>
    <time_frame>60 minutes</time_frame>
    <description>Umbilical pH</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patients' satisfaction</measure>
    <time_frame>24 hours</time_frame>
    <description>Patients' satisfaction measured by a questionary</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Anesthesia, Spinal</condition>
  <condition>Cesarean Section</condition>
  <arm_group>
    <arm_group_label>Fasting</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patient will be &quot;nil per os&quot; from midnight before their cesarean section</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rehydration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient will receive 400 mL of Nutricia Preop ® 2 hours before their cesarean section</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutricia PreOp</intervention_name>
    <description>Oral rehydration 2 hours before the scheduled cesarean section under spinal anesthesia</description>
    <arm_group_label>Rehydration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ≥ 18 years old&#xD;
&#xD;
          -  Scheduled for a scheduled cesarean, under spinal anesthesia (CSE)&#xD;
&#xD;
          -  Signature of informed consent&#xD;
&#xD;
          -  Single pregnancy of ≥ 36 weeks&#xD;
&#xD;
          -  150 cm &lt;height &lt;180 cm&#xD;
&#xD;
          -  50 kg &lt;weight &lt;100 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient's refusal&#xD;
&#xD;
          -  Contraindication to spinal anesthesia&#xD;
&#xD;
          -  Allergy to a product used for anesthesia&#xD;
&#xD;
          -  Age &lt; 18&#xD;
&#xD;
          -  Known or pregnancy-related hypertension&#xD;
&#xD;
          -  Gestational diabetes with insulin or pre-existing diabetes with insulin&#xD;
&#xD;
          -  Total language barrier without possibility of translation&#xD;
&#xD;
          -  ASA ≥ 3&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Denis Schmartz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Brugmann</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Denis Schmartz, MD</last_name>
    <phone>3224773996</phone>
    <email>denis.schmartz@chu-brugmann.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Philippe Van Der Linden, MD</last_name>
    <phone>3224773996</phone>
    <email>philippe.vanderlinden@chu-brugmann.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU Brugmann</name>
      <address>
        <city>Brussels</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Denis Schmartz, MD</last_name>
      <phone>+3224773996</phone>
      <email>denis.schmartz@chu-brugmann.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Havas F, Orhan Sungur M, Yenigun Y, Karadeniz M, Kilic M, Ozkan Seyhan T. Spinal anesthesia for elective cesarean section is associated with shorter hospital stay compared to general anesthesia. Agri. 2013;25(2):55-63. doi: 10.5505/agri.2013.42204.</citation>
    <PMID>23720079</PMID>
  </reference>
  <reference>
    <citation>American Society of Anesthesiologists Committee. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9. No abstract available.</citation>
    <PMID>21307770</PMID>
  </reference>
  <reference>
    <citation>Itoh S, Arai M, Kuroiwa M, Ando H, Okamoto H. [Effect of Preoperative Oral Rehydration on the Hypotension during Spinal Anesthesia.]. Masui. 2016 Sep;65(8):786-789. Japanese.</citation>
    <PMID>30351587</PMID>
  </reference>
  <reference>
    <citation>Awad S, Varadhan KK, Ljungqvist O, Lobo DN. A meta-analysis of randomised controlled trials on preoperative oral carbohydrate treatment in elective surgery. Clin Nutr. 2013 Feb;32(1):34-44. doi: 10.1016/j.clnu.2012.10.011. Epub 2012 Nov 7.</citation>
    <PMID>23200124</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>Kim J, Adhikari M, Dhamane S, Hagstrom AE, Kourentzi K, Strych U, Willson RC, Conrad JC. Detection of viruses by counting single fluorescent genetically biotinylated reporter immunophage using a lateral flow assay. ACS Appl Mater Interfaces. 2015 Feb 4;7(4):2891-8. doi: 10.1021/am5082556. Epub 2015 Jan 23.</citation>
    <PMID>25581289</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>November 4, 2021</last_update_submitted>
  <last_update_submitted_qc>November 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brugmann University Hospital</investigator_affiliation>
    <investigator_full_name>Denis SCHMARTZ</investigator_full_name>
    <investigator_title>Head of department, 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>
  <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/NCT04450667
org study id: CHUB_MATHYPOTA
nct id: NCT04450667
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study of the impact of preoperative oral rehydration on the incidence of spinal
      anesthesia-induced hypotension for scheduled cesarean section.
What is already known ? Arterial hypotension is one of the most common complications
      following spinal anesthesia (60%). Several measures have been studied to prevent this
      hypotension, such as intravenous vascular filling (preloading, coloading), using different
      filling fluids (colloids vs crystalloids), preventive administration of vasopressors,
      reduction of doses and volumes administered in spinal anesthesia.

      Only one study has evaluated the impact of oral rehydration on hypotension after spinal
      anesthesia.

      Hypothesis:

      The investigatord wish to demonstrate that an oral rehydration 2 hours before surgery,
      reduces by 50% the incidence of hypotension and / or the use of vasopressors, after spinal
      anesthesia

      Primary outcome:

      Decrease in the incidence of hypotension and / or use of vasopressor agents by 50% in the
      "rehydration" group compared to the "fasting" group.

      Secondary outcomes:

      Reduced incidence of nausea / vomiting side effects, effect on umbilical pH, APGAR score,
      patient satisfaction

      Design:

      Interventional clinical study. Monocentric, single-blind, randomized, single-blind,
      controlled trial with 2 groups of 50 patients.

      Inclusion criteria:

      Patients ≥ 18 years old Scheduled for a scheduled cesarean, under spinal anesthesia Signature
      of informed consent Single pregnancy of ≥ 36 weeks 150 cm <height <180 cm 50 kg <weight <100
      kg

      Exclusion criteria:

      Patient's refusal Contraindication to spinal anesthesia Allergy to a product used for
      anesthesia Age < 18 Known or pregnancy-related hypertension Gestational diabetes with insulin
      or pre-existing diabetes with insulin Total language barrier without possibility of
      translation ASA ≥ 3

      Purpose of the study:

      The purpose of this study is to show that oral rehydration 2 hours before the induction of
      anesthesia reduces the incidence of spinal anesthesia-induced hypotension.

      The primary hypothesis is that the oral intake of 400 ml of clear liquids (in the form of a
      standardized carbohydrate solution, NutriciaPreop®) would reduce the hypovolemia related to
      the preoperative fasting period, and thus reduce the risk of hypotension following the
      installation of the block.

      Primary outcome:

      Decrease the incidence of maternal hypotension and / or the use of vasoactive agents in the
      "rehydration" group by 50%. The blood pressure will be measured by pneumatic cuff, on the
      arm, once per minute from the entrance to the operating room until the umbilical cord is
      clamped, then once every 5 minutes until the end of the procedure

      Secondary outcomes:

      Assess the incidence and severity of nausea / vomiting, umbilical pH, APGAR score, patient
      comfort (using a visual analog scale graduated from 1 to 10, as well as a satisfaction score
      of 1 at 5)

      Study design:

      This is a prospective interventional, single-blind, unicentric, randomized controlled study
      comprising 2 arms of 50 patients.

      An "oral rehydration" arm in which patients will receive 400ml NutriciaPreop to drink 2 hours
      before anesthesia, and an "fasting" arm in which patients will be fasting since midnight the
      day before the intervention. As part of the study, the NutriciaPreop solution is provided
      free to patients.

      Duration of the study Including 1 patient per working day, the study will last 6 months. We
      are considering to set the duration of the study at 9 months.

      Materials and methods After recruitment at the anesthesia consultation and signing of the
      consent, the randomization is carried out by a member of the medical team not involved in the
      planned cesarean section.

      Randomization is done by a sealed, opaque envelope containing the group and the instructions
      which will be sent to the midwives of the patient's hospital unit.

      "Rehydration" arm: 2 boxes of 200 ml Nutricia PreOp to drink 2 hours before anesthesia
      "Fasting" arm: patient fasting since midnight the day before the intervention Identical
      premedication in the 2 groups: metoclopramide 10mg + ranitidine 50 mg in 50 ml of 0.9% NaCl
      IV, as well as 30 ml of sodium citrate per os, on call in the operating room.

      Patients will be equipped with 18G venous catheters with obturators to avoid receiving any
      maintenance fluid before anesthesia (except premedication) Upon arrival in the operating
      room, the team performs the usual safety checklist.

      Patient monitoring with ECG scope, PNI cuff, Sp02 The anesthesiologist performs the
      standardized spinal anesthesia: 2.2 ml of hyperbaric bupivacaine 0.5% + 0.5 ml of sufentanil
      concentration 5 micrograms / ml + 100 microgram of morphine (0.1 ml), for a total volume of
      2.8 ml, injected in 30-60 seconds, after reflux of CSF into the L3 / L4 space, previously
      identified by ultrasound.

      At the start of the injection, the anesthesiologist's assistant loads the venous catheter
      with a coloading of 10 ml / kg (ideal weight) of a Hartmann solution (crystalloid balance
      containing lactate), then maintenance of 1 ml / kg / h until the umbilical cord is clamped.

      For the spinal anesthesia, the patient is placed in a seated position, legs hanging. After
      this has been done, patient is placed in supine position, except for those with a body mass
      index greater than 35 kG / m2, which are placed in the "beach chair" position. Patients with
      a BMI≥35 are installed on a "troop elevation pillow". In all cases a tilt of 10 ° to the left
      will be applied.

      Blood pressure measurement per minute on the cuff. Sensory motor block is tested at 5 and 10
      min with cold test (ether) and Pricktest. Finally, the surgeon tests before cutting with a
      pair of pliers, on the incision area.

      Hypotension is defined by a fall of at least 20% in systolic BP compared to the reference
      systolic BP and / or the need to use a vasoactive drug.

      Correction of any decrease in systolic BP by boli of 6 micrograms of Noradrenaline in IVD.
      Possibility of using another vasoactive drug depending on the clinical situation (choice of
      responsible anesthesiologist) The analysis will be performed until the umbilical cord is
      clamped, then, the anesthesiologist wiil follow the standard cesarean management protocol.

      The umbilical pH as well as the APGAR score of the newborn will be noted. The patient's
      nausea / vomiting episodes will also be scored and graded on a scale of 0 to 3 with 0 = no
      nausea-vomiting, 1: moderate nausea not requiring treatment, 2: moderate nausea responding to
      treatment, 3: nausea not responding to treatment or vomiting.

      A digital scale for assessing patient satisfaction and well-being will be used once
      preoperatively, after signing the consent, and once postoperatively.

      Randomization:

      Bloc randomization by bloc of 4.

      Statistical analysis:

      Based on our incidence of 60% of hypotension, a power analysis shows that 42 patients will be
      needed in each group in order de detect a 50% decrease in the incidence of hypotension; with
      a power of 80% and alpha fixed at 0.05. 8 patients will be added to each group to compensate
      for possible dropouts.

      Analysis will be done as "intention to treat". Incidence of hypotension will be analyzed by a
      Chi-square test and the confidence interval will be reported. Secondary outcomes will be
      analysed by Chi-square test or Fisher's exact test for discontinuous variable and t-test or
      Mann-Whitney-U test for continuous variables.

      A P value < 0.05 will be considered as significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Hypotension reduction
time frame: 60 minutes
description: We aim for a 50% reduction in the incidence of hypotension following spinal anesthesia for scheduled C-section.
measure: N+/V+
time frame: 60 minutes
description: Incidence of nausea and/or vomiting
measure: Umbilical pH
time frame: 60 minutes
description: Umbilical pH
measure: Patients' satisfaction
time frame: 24 hours
description: Patients' satisfaction measured by a questionary
arm group label: Fasting
arm group type: No Intervention
description: Patient will be "nil per os" from midnight before their cesarean section
arm group label: Rehydration
arm group type: Active Comparator
description: Patient will receive 400 mL of Nutricia Preop ® 2 hours before their cesarean section
intervention type: Dietary Supplement
intervention name: Nutricia PreOp
description: Oral rehydration 2 hours before the scheduled cesarean section under spinal anesthesia
arm group label: Rehydration
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Denis Schmartz, MD
role: Principal Investigator
affiliation: CHU Brugmann
last name: Denis Schmartz, MD
phone: 3224773996
email: denis.schmartz@chu-brugmann.be
last name: Philippe Van Der Linden, MD
phone: 3224773996
email: philippe.vanderlinden@chu-brugmann.be
facility: 
status: Recruiting
contact: 
country: Belgium
citation: Havas F, Orhan Sungur M, Yenigun Y, Karadeniz M, Kilic M, Ozkan Seyhan T. Spinal anesthesia for elective cesarean section is associated with shorter hospital stay compared to general anesthesia. Agri. 2013;25(2):55-63. doi: 10.5505/agri.2013.42204.
PMID: 23720079
citation: American Society of Anesthesiologists Committee. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9. No abstract available.
PMID: 21307770
citation: Itoh S, Arai M, Kuroiwa M, Ando H, Okamoto H. [Effect of Preoperative Oral Rehydration on the Hypotension during Spinal Anesthesia.]. Masui. 2016 Sep;65(8):786-789. Japanese.
PMID: 30351587
citation: Awad S, Varadhan KK, Ljungqvist O, Lobo DN. A meta-analysis of randomised controlled trials on preoperative oral carbohydrate treatment in elective surgery. Clin Nutr. 2013 Feb;32(1):34-44. doi: 10.1016/j.clnu.2012.10.011. Epub 2012 Nov 7.
PMID: 23200124
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: Kim J, Adhikari M, Dhamane S, Hagstrom AE, Kourentzi K, Strych U, Willson RC, Conrad JC. Detection of viruses by counting single fluorescent genetically biotinylated reporter immunophage using a lateral flow assay. ACS Appl Mater Interfaces. 2015 Feb 4;7(4):2891-8. doi: 10.1021/am5082556. Epub 2015 Jan 23.
PMID: 25581289
responsible party type: Principal Investigator
investigator affiliation: Brugmann University Hospital
investigator full name: Denis SCHMARTZ
investigator title: Head of department, anesthesiology
mesh term: Hypotension
sharing ipd: No