Effect of Adding a Low-Dose Epinephrine Bolus Prior to Infusion on Maternal Hemodynamic Stability During Cesarean Section

Официальное название

Effect of Adding a Low-Dose Epinephrine Bolus Prior to Infusion on Maternal Hemodynamic Stability During Cesarean Section Under Spinal Anesthesia: A Randomized Clinical Trial

Обзор

In North America, norepinephrine, ephedrine, and epinephrine have been recommended as first-choice vasopressors for the treatment of spinal hypotension during cesarean delivery. However, in international consensus guidelines, epinephrine was recommended for circulatory collapse only. Phenylephrine infusion is an important therapeutic strategy for preventing spinal-induced hypotension (SIH) in cesarean delivery, as it decreases the incidence of hypotension, nausea, and vomiting. However, high doses may reduce maternal heart rate and cardiac output in a dose-dependent manner. Ephedrine, previously considered the first-choice drug, has both α and β receptor agonistic activity and causes norepinephrine release from sympathetic neurons. Its β1 effect increases heart rate and contractility, but may cause undesirable tachycardia. Tachyphylaxis can develop with repeated doses. Norepinephrine, the biosynthetic precursor of epinephrine, has both potent α and weak β agonist effects, tending to cause bradycardia. Despite a lower incidence of hypotension with prophylactic norepinephrine, PSH still occurs in up to 30% of parturients undergoing cesarean section. The administration of a bolus dose of epinephrine prior to continuous infusion is an unusual practice in obstetric anesthesia, but has been reported to be safe in other contexts and in pregnant women when used for hemodynamic support. Epinephrine has both potent α- and β-adrenoceptor agonist activity. Its β effects could offset reflex decreases in maternal HR and CO during spinal anesthesia for cesarean delivery. Although some studies compared epinephrine infusion with phenylephrine, it remains unclear whether adding an initial bolus of epinephrine before infusion offers superior maternal hemodynamic stability compared to infusion alone.

Вмешательства

• Препарат Epinephrine (Adrenaline) bolus then infusion
  A bolus of 4 mcg epinephrine will be given just after spinal anaesthesia followed by 0.03 mcg/kg/min infusion which is equivalent to 1.8 mcg/kg/hr. Epinephrine dose of 3000 mcg will be diluting in 500 mL saline (6 mcg/mL), and the infusion rate will be set on 0.3 mL/kg/hr.
• Препарат Epinephrine (Adrenaline) infusion
  Patients will receive the epinephrine infusion dose of 0.03 mcg/Kg/min (6) immediately without the bolus.

Первичные конечные точки

• Incidence of post-spinal hypotension [Срок оценки: up to 2 hours after spinal anesthesia]

Вторичные конечные точки (9)

• Incidence of severe post-spinal hypotension [Срок оценки: up to 2 hours after spinal anaesthesia]
• Number of hypotensive and severe hypotensive episodes per patient [Срок оценки: up to 2 hours after spinal anaesthesia]
• Incidence of reactive hypertension (systolic blood pressure ≥ 120% of baseline) [Срок оценки: up to 2 hours after spinal anaesthesia]
• Number of reactive hypertension episodes per patient [Срок оценки: up to 2 hours after spinal anaesthesia]
• Incidence of tachycardia (heart rate >130% baseline, not related to hypotension) [Срок оценки: up to 2 hours after spinal anaesthesia]
• Incidence of intraoperative nausea and vomiting [Срок оценки: up to 2 hours after spinal anesthesia]
• Total intraoperative norepinephrine consumption [Срок оценки: up to 2 hours after spinal anaesthesia]
• Fetal outcomes: umbilical artery blood gases [Срок оценки: up to 5 minutes after fetal delivery]
• • Fetal outcomes: Apgar scores [Срок оценки: up to 5 minutes after delivery]

Критерии участия

Критерии включения

• Age: 18 to 35 years.
• American Society of Anesthesiologists (ASA) physical status II.
• Undergoing Elective Lower Segment Cesarean Section under Spinal Anesthesia.

Критерии исключения

• Uncontrolled cardiac morbidities as reduction of ejection fraction< 60%, History (within 3months) of myocardial infarction, cerebrovascular accident, transient ischemic attacks or coronary artery disease/stents
• Poorly controlled Hypertensive disorders of pregnancy
• Peripartum bleeding
• Multiple pregnancies (e.g., twin gestations)
• Coagulation disorders defined as platelet count <100,000/μL, INR >1.4, or known inherited clotting factor deficiency.
• Baseline systolic blood pressure (SBP) < 100 mmHg or >130 mmHg
• Refusal of patients.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Kasr Alaini hospital — Cairo

Идентификаторы

NCT: NCT07480889 · MS-572-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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