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Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery

25 août 2022 mis à jour par: Maha Mostafa Ahmad, MD, Kasr El Aini Hospital

The Use of Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Cesarean Delivery: a Randomized Controlled Dose-finding Trial

Maternal hypotension after spinal block is a common complication after subarachnoid block in this population. The incidence of maternal hypotension is nearly 60% when prophylactic vasopressors are not used. Therefore, it is highly recommended to use vasopressors, preferably as continuous infusion, for prophylaxis rather than delaying their use until hypotension occurs.

Phenylephrine (PE) is the recommended drug for prophylaxis against hypotension during cesarean delivery; however, the use of PE is commonly associated with decreased heart rate and probably cardiac output because PE is a pure alpha adrenoreceptor agonist. Introduction of NE in obstetric practice had shown favorable maternal and neonatal outcomes and was associated with higher heart rate and cardiac output compared to PE. However, there is still some mothers who develop bradycardia and diminished cardiac output with the use of NE. The most desired scenario during hemodynamic management of mothers during cesarean delivery would achieve the least possible incidences of maternal hypotension, bradycardia and reactive hypertension. Therefore, it is warranted to reach a vasopressor regimen with the most stable hemodynamic profile.

In the last year, epinephrine was reported for the first time in obstetric practice with acceptable safety on the mother and the fetus. However, there is still lack of data about the most appropriate dose for infusion during cesarean delivery. This study aims to compare three prophylactic infusion rates for epinephrine during cesarean delivery.

Aperçu de l'étude

Description détaillée

Upon arrival to the operating room, the patient will be in supine position with left uterine displacement using a wedge below the right buttock. Routine monitoring will be applied (electrocardiography, pulse oximetry, and non-invasive blood pressure monitor). An 18G-cannula will be inserted, and the patients will receive 10 mg metoclopramide. Baseline heart rate and systolic blood pressure will be recorded as the average of three consecutive readings with 2-minutes interval.

Lactated Ringer's solution will be infused at rate of 15 mL/Kg over 10 minutes as a co-load; spinal anesthesia will be achieved by injecting 10 mg of hyperbaric bupivacaine and 20 mcg fentanyl into the subarachnoid space at L3-L4 or L4-L5 interspace using 25G spinal needle.

After subarachnoid block, mothers will be placed in supine position with left-lateral tilt and the vasopressor infusion will be started.

  • 0.01 mcg group
  • 0.02 mcg group
  • 0.03 mcg group The vasopressor infusion will be through the same line as the fluid a three-way stopcock. The vasopressor infusion will be stopped if heart rate became ≥130% of baseline or systolic blood pressure ≥120% of baseline, otherwise the infusion will be stopped 5 minutes after delivery of the baby.

Block success will be assessed after 5 minutes from intrathecal injection of local anesthetic; and will be confirmed if sensory block level is at T4.

Post-spinal hypotension (defined as systolic blood pressure ≤80% of the baseline reading during the period from intrathecal injection to delivery of the fetus) will be managed by administration of 9 mg of ephedrine Severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading during the period from intrathecal injection to delivery of the fetus) will be managed by administration IV ephedrine 15 mg.

Reactive hypertension (defined as systolic blood pressure ≥120% of the baseline reading) will be managed by stoppage of the infusion till the next systolic blood pressure reading. The infusion will be then re-started at the half of the initial rate, when systolic blood pressure decreases to be within 20% of the baseline reading.

Intraoperative bradycardia (defined as heart rate less than 55 bpm) will be managed by IV atropine bolus (0.5 mg) will be administered.

Fluid administration will be continued up to a maximum of 1.5 liters. An oxytocin bolus (0.5 IU) will be delivered over five seconds after delivery the infused at a rate of 2.5 IU/hour.

Type d'étude

Interventionnel

Inscription (Anticipé)

276

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

      • Cairo, Egypte, 11562
        • Recrutement
        • Kasr Alaini Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 40 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • full-term singleton pregnant women
  • American society of anesthesiologist-physical status I or II,
  • scheduled for elective cesarean delivery

Exclusion Criteria:

  • Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction < 50%, heart block, and arrhythmias),
  • hypertensive disorders of pregnancy,
  • peripartum bleeding,
  • coagulation disorders (patients with INR >1.4 and or platelet count < 80000 /dL) or
  • any contraindication to regional anesthesia,
  • and baseline systolic blood pressure (SBP) < 100 mmHg

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 0.03 mcg group
epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby
epinephrine infusion rate of 0.03 mcg/kg/min
Autres noms:
  • adrénaline
Comparateur actif: 0.02 mcg group
epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby
epinephrine infusion rate of 0.02 mcg/kg/min
Autres noms:
  • adrénaline
Comparateur actif: 0.01 mcg group
epinephrine infusion will be started after subarachnoid block until 5 minutes after delivery of the baby
epinephrine infusion rate of 0.01 mcg/kg/min
Autres noms:
  • adrénaline

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
incidence of postspinal hypotension
Délai: 1 minute after subarachnoid injection till 5 minutes after baby delivery
systolic blood pressure ≤80% of the baseline reading
1 minute after subarachnoid injection till 5 minutes after baby delivery

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
incidence of tachycardia
Délai: 1 minute after subarachnoid injection till 5 minutes after baby delivery
heart rate > 130% of baseline
1 minute after subarachnoid injection till 5 minutes after baby delivery
incidence of hypertension
Délai: 1 minute after subarachnoid injection till 5 minutes after baby delivery
systolic blood pressure >120% of baseline
1 minute after subarachnoid injection till 5 minutes after baby delivery
incidence of severe hypotension
Délai: 1 minute after subarachnoid injection till 5 minutes after baby delivery
systolic blood pressure ≤60% of the baseline reading
1 minute after subarachnoid injection till 5 minutes after baby delivery
mean heart rate
Délai: 1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
beat per minute
1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
mean systolic blood pressure
Délai: 1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
mmHg
1 minute after subarachnoid injection, every 2 minutes during procedure, till 5 minutes after baby delivery
total ephedrine requirement
Délai: 1 minute after subarachnoid injection till 5 minutes after baby delivery
mg
1 minute after subarachnoid injection till 5 minutes after baby delivery
total atropine requirement
Délai: 1 minute after subarachnoid injection till 5 minutes after baby delivery
mg
1 minute after subarachnoid injection till 5 minutes after baby delivery
Apgar score
Délai: 5 minutes after delivery
Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition
5 minutes after delivery
umbilical blood pH
Délai: 5 minutes after delivery
pH
5 minutes after delivery
umbilical blood PCO2
Délai: 5 minutes after delivery
mmHg
5 minutes after delivery
umbilical blood PO2
Délai: 5 minutes after delivery
mmHg
5 minutes after delivery
umbilical blood HCO3
Délai: 5 minutes after delivery
mmol/L
5 minutes after delivery

Collaborateurs et enquêteurs

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Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

21 mars 2022

Achèvement primaire (Anticipé)

1 août 2022

Achèvement de l'étude (Anticipé)

1 août 2022

Dates d'inscription aux études

Première soumission

23 février 2022

Première soumission répondant aux critères de contrôle qualité

4 mars 2022

Première publication (Réel)

15 mars 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 août 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 août 2022

Dernière vérification

1 août 2022

Plus d'information

Termes liés à cette étude

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Informations sur les médicaments et les dispositifs, documents d'étude

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Étudie un produit d'appareil réglementé par la FDA américaine

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