Effect of Propofol Administration Time on the Incidence and Severity of Intrathecal Morphine-induced Pruritus in Parturient Undergoing Elective Cesarean Delivaries
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: Morphine intrathecal, propofol, propofol.
- Кому может быть актуально
- Состояния в реестре: Cesarean Section. Базовые параметры: 18 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
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Effect of Propofol Administration Time on the Incidence and Severity of Intrathecal Morphine-induced Pruritus in Parturient Undergoing Elective Cesarean Delivaries: A Prospective, Randomized, Comparative Controlled Study
Обзор
Our hypothesis suggests that Administration time of intravenous propofol may affect Pruritus incidence and severity that occur after intrathecal morphine in parturient undergoing elective cesarean section (CS). the aim of the study is to investigate effect of prophylactic administration of intravenous sub-hypnotic dose of propofol before intrathecal morphine compared with the administration after intrathecal morphine on intrathecal morphine-induced pruritus incidence and severity in parturient undergoing elective cesarean delivaries.
Подробное описание
Neuraxial Anaesthesia is a frequent anaesthetic approach for cesarean delivery and other lower abdominal and lower limb anaesthetic procedures. Neuraxial morphine addition to local anaesthetic provides an effective and prolonged postoperative analgesia, but has been associated with a frequent incidence of pruritus and postoperative nausea and vomiting (PONV).
Neuraxial opioids are thought to act on central nervous system pathways to cause pruritus. Although precise mechanisms are incompletely understood, Numerous interventions have been investigated to prevent opioid-induced pruritus in the peripartum period as: Opioid receptor agonist-antagonists, Serotonin receptor antagonists.
There is dense concentration of opioid receptors and 5-HT3 receptors in the dorsal part of the spinal cord and nucleus of the spinal tract of the trigeminal nerve in the medulla. Activation of these receptors by neuraxial opioid administration or by circulating estrogen in parturient results in pruritus which is usually localized to face, neck, or upper thorax.
Propofol exerts its antipruritic action through inhibition of the posterior horn transmission in spinal cord. Series of clinical trials have reported that a sub-hypnotic dose of propofol is equally effective in reducing the incidence of pruritus following intrathecal morphine. however these studies have limited information about dose and timing of administration of propofol.
Вмешательства
- Препарат Morphine intrathecal
patients intrathecal anaesthesia with morphine - Препарат propofol
patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection 15 min before the end of surgery - Препарат propofol
patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection just before intrathecal anaesthesia
Первичные конечные точки
- severity of pruritus that occurs after intrathecal morphine in parturient undergoing elective cesarean section (CS) by pruritus Grading system. [Срок оценки: 24 hours]
Критерии участия
Критерии включения
- Parturient of American Society of Anaesthesiologists (ASA) class I or II physical status.
- Age: 20-40 years.
- At term gestation (≥ 37 weeks) with a singleton uncomplicated pregnancy.
- Elective cesarean delivery under intrathecal anaesthesia
Критерии исключения
- Parturient refusal.
- Significant organ dysfunctions (e.g., cardiac, respiratory, renal, or liver disorders).
- Morbid obesity (BMI >35).
- Parturient with known hypersensitivity to propofol, morphine or amide local anaesthetics.
- Parturient with pruritogenic systemic disease.
- A coexisting skin disorder or preexisting pregnancy induced pruritus.
- Parturient with any contraindication for intrathecal anaesthesia, e.g. coagulopathy.
- Emergency cesarean section.
- Failed or unsatisfactory intrathecal block.
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
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Публикации
- Kumar K, Singh SI. Neuraxial opioid-induced pruritus: An update. J Anaesthesiol Clin Pharmacol. 2013 Jul;29(3):303-7. doi: 10.4103/0970-9185.117045. PMID 24106351
- Singh PM, Sultan P, O'Carroll J, Blake L, Carvalho B, Singh NP, Monks DT. Pharmacological agents for prevention of pruritus in women undergoing Caesarean delivery with neuraxial morphine: a systematic review and Bayesian network meta-analysis. Br J Anaesth. 2023 Sep;131(3):556-571. doi: 10.1016/j.bja.2023.05.028. Epub 2023 Jul 14. PMID 37455197
- Kampo S, Afful AP, Mohammed S, Ntim M, Buunaaim ADB, Anabah TW. Sub-hypnotic dose of propofol as antiemetic prophylaxis attenuates intrathecal morphine-induced postoperative nausea and vomiting, and pruritus in parturient undergoing cesarean section - a randomized control trial. BMC Anesthesiol. 2019 Sep 14;19(1):177. doi: 10.1186/s12871-019-0847-y. PMID 31521119
Идентификаторы
NCT: NCT06715657 · propofol pruritus incidence CS