Набор по приглашению NCT07615595

Dexamethasone to Prevent Side Effects of Spinal Anesthesia in Cesarean Delivery

Фаза IV С лечением Hypotension During Cesarean Delivery Postoperative Nausea and Vomiting (PONV) Pain, Postoperative

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: Dexamethasone, Placebo.
Кому может быть актуально: Состояния в реестре: Hypotension During Cesarean Delivery, Postoperative Nausea and Vomiting (PONV), Pain, Postoperative. Базовые параметры: от 18 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: Вьетнам
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

Evaluation of the Effectiveness of Intravenous Dexamethasone in Preventing Adverse Effects of Spinal Anesthesia in Parturients Undergoing Cesarean Delivery

Обзор

The goal of this clinical trial is to evaluate the effectiveness of intravenous dexamethasone in preventing adverse effects of spinal anesthesia and prolonging postoperative analgesia in parturients undergoing elective cesarean delivery. The main questions it aims to answer are: Does intravenous dexamethasone reduce the incidence of post-spinal hypotension? Does intravenous dexamethasone reduce the incidence of postoperative nausea and vomiting (PONV)? Does intravenous dexamethasone prolong the duration of postoperative analgesia? Researchers will compare intravenous dexamethasone (8 mg) to a placebo (0.9% saline) to see if dexamethasone effectively prevents post-spinal hypotension and PONV, and improves postoperative pain relief. Participants will: Receive an intravenous injection of either 8 mg dexamethasone or a placebo (2 mL 0.9% saline) prior to receiving spinal anesthesia. Have their blood pressure recorded frequently (every minute for the first 20 minutes, then every 5 minutes until the completion of surgery). Undergo sensory block assessment (via cold testing) and motor block evaluation (using the Bromage scale). Have maternal glycemia and neonatal safety monitored for potential steroid-related adverse effects.

Вмешательства

Препарат Dexamethasone
Intravenous administration of 8 mg dexamethasone immediately before the induction of spinal anesthesia.
Другое Placebo
Intravenous administration of 2 mL of 0.9% normal saline as a placebo immediately before the induction of spinal anesthesia.

Первичные конечные точки

Incidence of Post-Spinal Hypotension [Срок оценки: From the induction of spinal anesthesia until the completion of surgery]

Вторичные конечные точки (2)

Incidence of Postoperative Nausea and Vomiting (PONV) [Срок оценки: From the induction of spinal anesthesia until discharge from the post-anesthesia care unit (PACU) (estimated up to 6 hours)]
Duration of Postoperative Analgesia [Срок оценки: From the administration of spinal anesthesia until the first request for rescue analgesia (estimated up to 24 hours)]

Критерии участия

Критерии включения

Age ≥ 18 years
Singleton pregnancy
Gestational age ≥ 37 weeks
American Society of Anesthesiologists (ASA) physical status classification of II-III
Planned for elective cesarean delivery under spinal anesthesia