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Идёт набор NCT07322419

Hemodynamics During Cesarean Delivery Under Spinal Anesthesia With Norepinephrine Versus Ephedrine

Фаза IV С лечением Cesarean Delivery Spinal Anesthesia for Cesarean Section

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Spinal Anesthesia with Bupivacaine and Fentanyl, Crystalloid Coload 1000 mL, Cesarean Delivery, Transthoracic Echocardiography.
Кому может быть актуально
Состояния в реестре: Cesarean Delivery, Spinal Anesthesia for Cesarean Section. Базовые параметры: 19 лет — 40 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Официальное название

Echocardiographic Evaluation of Cardiac Output During Cesarean Delivery Under Spinal Anesthesia Using Norepinephrine Versus Ephedrine: A Randomized Controlled Trial

Обзор

Echocardiography will be used to measure cardiac output and calculate other important hemodynamic variables in healthy patients with full-term singleton pregnancy during cesarean delivery under conventional spinal anesthesia using 2 different vasopressor drugs: norepinephrine in 1 group versus ephedrine in another group.

Вмешательства

  • Процедура Spinal Anesthesia with Bupivacaine and Fentanyl
    Spinal anesthesia using 2.5 mL of 0.5% hyperbaric bupivacaine (12.5 mg) and 15 mcg of fentanyl at the L4-L5 or L3-L4 interspace
  • Препарат Crystalloid Coload 1000 mL
    Ringer acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection
  • Процедура Cesarean Delivery
    Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization
  • Лучевая терапия Transthoracic Echocardiography
    Measurement of cardiac output in supine position with left lateral tilt at baseline, at 1 and 10 minutes after intrathecal injection, and immediately after delivery
  • Препарат Intravenous Norepinephrine Bolus
    Prophylactic IV norepinephrine bolus of 6 mcg will be administered immediately after intrathecal injection, followed by rescue IV norepinephrine boluses of 3, 6, and 9 mcg when systolic blood pressure decreases below 90%, 80%, and 70% of baseline value, respectively
  • Препарат Intravenous Ephedrine Bolus
    Prophylactic IV ephedrine bolus of 6 mg will be administered immediately after intrathecal injection, followed by rescue IV ephedrine boluses of 3, 6, and 9 mg when systolic blood pressure decreases below 90%, 80%, and 70% of baseline value, respectively

Первичные конечные точки

  • Difference between the 2 groups in cardiac output at 10 minutes after intrathecal injection [Срок оценки: From the start of spinal anesthesia until delivery]
Вторичные конечные точки (12)
  • Differences between the 2 groups in cardiac output at 1 minute after intrathecal injection and after delivery [Срок оценки: From the start of spinal anesthesia until delivery]
  • Differences between the 2 groups in stroke volume at 1 and 10 minutes after intrathecal injection, and after delivery [Срок оценки: From the start of spinal anesthesia until delivery]
  • Differences between the 2 groups in heart rate at 1 and 10 minutes after intrathecal injection, and after delivery [Срок оценки: From the start of spinal anesthesia until delivery]
  • Differences between the 2 groups in mean arterial pressure at 1 and 10 minutes after intrathecal injection, and after delivery [Срок оценки: From the start of spinal anesthesia until delivery]
  • Differences between the 2 groups in systemic vascular resistance at 1 and10 minutes after intrathecal injection, and after delivery [Срок оценки: From the start of spinal anesthesia until delivery]
  • Number of patients receiving rescue vasopressor [Срок оценки: From the start of spinal anesthesia until delivery]
  • Incidence of hypotension [Срок оценки: From the start of spinal anesthesia until delivery]
  • Incidence of severe hypotension [Срок оценки: From the start of spinal anesthesia until delivery]
  • Incidence of bradycardia [Срок оценки: From the start of spinal anesthesia until delivery]
  • Incidence of nausea and/or vomiting [Срок оценки: From the start of spinal anesthesia until delivery]
  • Total vasopressor dose [Срок оценки: From the start of spinal anesthesia until delivery]
  • Neonatal Apgar score at 1 and 5 minutes after delivery [Срок оценки: 1 and 5 minutes after delivery]

Критерии участия

Критерии включения

  • American Society of Anesthesiologists physical status II.
  • Singleton, full term pregnancy.
  • Scheduled cesarean delivery under spinal anesthesia.

Критерии исключения

  • Height <150 or >180 cm.
  • Weight <60 or >110 kg.
  • Body mass index (BMI) <18.5 or ≥35 kg/m².
  • Women presenting in labor.
  • Any contraindication to spinal anesthesia: increased intracranial pressure, coagulopathy, or local skin infection.
  • Chronic or pregnancy-induced hypertension.
  • Baseline systolic blood pressure >140 mm Hg.
  • Hemoglobin <10 g/dl.
  • Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease.
  • Polyhydramnios or known significant fetal abnormalities.
  • Current administration of vasoactive drugs such as: beta blockers, salbutamol, or thyroxin.

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Department of Anesthesia and Surgical Critical Care, Mansoura University Hospitals — Al Mansurah

Идентификаторы

NCT: NCT07322419 · MD.25.04.982

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗