Caffeine and Prophylactic Noradrenaline Requirement During Cesarean Delivery
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: Caffeine (200 mg), Placebo.
- Кому может быть актуально
- Состояния в реестре: Spinal Hypotension, Vasopressor. Базовые параметры: 20 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effect of Preoperative Oral Caffeine on Prophylactic Noradrenaline Requirement During Cesarean Delivery: A Double-blind Placebo-controlled Trial
Обзор
Spinal anesthesia is the preferred regional technique in obstetric practice because it provides high maternal satisfaction and eliminates the need for airway manipulation. Despite these advantages, it is frequently complicated by spinal anesthesia-induced hypotension , defined as a reduction in systolic blood pressure of more than 20% from baseline or an absolute SBP below 100 mmHg. Spinal hypotension can have serious consequences, including maternal hypoperfusion that may lead to neurological or renal dysfunction, as well as fetal acidosis and bradycardia, which can compromise neonatal outcomes. The present study aims to evaluate the effect of preoperative caffeine administration on noradrenaline requirements during spinal anesthesia in obstetric patients. Specifically, the objectives are to compare noradrenaline requirements between the study groups and to assess the incidence of hypotension in both groups.
Подробное описание
Spinal anesthesia is considered the technique of choice in obstetric practice because it provides excellent maternal comfort and avoids the risks associated with airway manipulation during general anesthesia. Nevertheless, its use is often complicated by a significant drop in blood pressure, which can reduce blood flow to vital organs and impair maternal brain and kidney function. More importantly, decreased uteroplacental perfusion may compromise fetal oxygenation, leading to acidosis and slowing of the heart rate, both of which can negatively affect neonatal outcomes. These risks make it essential to explore preventive strategies that can stabilize blood pressure during spinal anesthesia. Caffeine, a widely available and inexpensive stimulant, enhances sympathetic nervous system activity and may counteract the vasodilation that contributes to low blood pressure. This study therefore investigates whether giving caffeine before anesthesia can reduce the need for noradrenaline, a commonly used vasopressor, and whether it can lower the incidence of hypotension. By examining these outcomes, the research aims to determine if caffeine could serve as a simple intervention to improve both maternal safety and neonatal wellbeing.
Вмешательства
- Препарат Caffeine (200 mg)
Patients will receive 200 mg oral caffeine 30 minutes before spinal anesthesia - Препарат Placebo
Patient will receive placebo capsule
Первичные конечные точки
- Average noradrenaline requirement [Срок оценки: After spinal anesthesia till delivery]
Вторичные конечные точки (3)
- Incidence of spinal hypotension [Срок оценки: After spinal anesthesia till end of delivery]
- Time to first hypotensive episode [Срок оценки: After spinal anesthesia till delivery of the baby]
- APGAR score [Срок оценки: at 10 minutes of delivery]
Критерии участия
Критерии включения
- Full-term singleton pregnant (>37 weeks)
- ASA II
- undergoing elective cesarean section.
Критерии исключения
- Patient refusal
- SBP < 100 mmHg
- Allergy to local anesthetics or caffeine
- Coagulopathy (INR>1.4 or platelets <75.000)
- Preeclampsia
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
- Четверное слепое
- Основная цель
- Профилактика
Центры проведения
Египет · 1 центр
- Cairo University Hospitals — Cairo
Публикации
- Helmy MA, Helmy KA, Darandly WME, Awad HH, Morsy F, Kaddah RA, Shamma MA, Milad LM. Prediction of spinal anesthesia-induced hypotension during cesarean delivery: a narrative review. J Anesth Analg Crit Care. 2026 Apr 11;6(1):61. doi: 10.1186/s44158-026-00382-y. PMID 41964042
- Helmy MA, Helmy KA, Kaddah RA, Shamma MA, Ali MA, Milad LM. Femoral artery Doppler as a novel predictor of spinal hypotension in elective cesarean delivery cases: a prospective observational study. Int J Obstet Anesth. 2025 Aug;63:104706. doi: 10.1016/j.ijoa.2025.104706. Epub 2025 Jun 18. PMID 40550198
- Helmy MA, Helmy KA, Zaki RM, Khatab SA, Embaby SA, Kaddah RA, Shamma MA, Milad LM. Caffeine before cesarean delivery: a novel preventive strategy against spinal hypotension, a double blind placebo-controlled trial. J Anesth Analg Crit Care. 2026 Jan 15;6(1):12. doi: 10.1186/s44158-025-00333-z. PMID 41535923
Идентификаторы
NCT: NCT07655245 · Caffeine and noradrenaline