Sugammadex Dose Finding Under Two Years Old
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: Sugammadex.
- Кому может быть актуально
- Состояния в реестре: Neuromuscular Blockade. Базовые параметры: до 23 мес. · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- South Korea
- 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
Reversal of Rocuronium-induced Neuromuscular Blockade by Sugammadex in Children Younger Than 2 Years Old: a Prospective Dose Finding Study
Обзор
This is a prospective dose-finding study of sugammadex for conventional reversal of rocuronium-induced neuromuscular blockade in children under two years of age. This study will explore 50% effective dose and 95% effective dose of sugammadex for reversal of neuromuscular blockade in less than two minutes under biased coin up-and-down method.
Подробное описание
The investigators are planning to enroll 33 patients to obtain data. The starting dose of sugammadex will be 0.5mg/kg. When the dose for a patient was not effective, the dose for next patient will be increased by 0.5mg/kg. When the dose was effective, the dose for next patient will be decreased by 0.5mg/kg or maintained, with a 1:1 of allocation ratio.
The investigators will also monitor incidence of any adverse events including residual blockade to evaluate safety of sugammadex in children younger than two years old.
Вмешательства
- Препарат Sugammadex
The starting dose of sugammadex will be 0.5mg/kg. When the dose for a patient was not effective, the dose for next patient will be increased by 0.5mg/kg. When the dose was effective, the dose for next patient will be decreased by 0.5mg/kg or maintained, with a 1:1 of allocation ratio.
Первичные конечные точки
- 50% effective dose [Срок оценки: From start of sugammadex administration to 2 minute after end of administration]
- 95% effective dose [Срок оценки: From start of sugammadex administration to 2 minute after end of administration]
Вторичные конечные точки (4)
- TOF result [Срок оценки: From start of sugammadex administration to 2 minute after end of administration]
- Residual blockade [Срок оценки: From start of sugammadex administration to 24 hours after end of administration]
- Blood pressure [Срок оценки: From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)]
- Pulse oximetry [Срок оценки: From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)]
Критерии участия
Критерии включения
- Childern younger than 2 years old who are scheduled to undergo surgery under general anesthesia
- American Society of Anesthesiologists Physical Status 1 or 2
Критерии исключения
- History of hypersensitivity to rocuronium or any anesthetics
- Presence of cardiovascular or genitourinary disease
- Presence of severe renal dysfunction or in need of dialysis
- Presence of severe hepatic dysfunction or coagualtion disorder
- Current state of administration of neuromuscular blocking agent on admission to operating room
- Concurrent use of any medications that affect the activity of neuromuscular blocking agents
- History of malignant hyperthermia
- Refusal to enroll in the study by one or more parents
- Presence of any other reasons that investigator regards inappropriate to enroll in the study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Последовательный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
South Korea · 1 центр
- Seoul National University Hospital — Seoul
Публикации
- Gijsenbergh F, Ramael S, Houwing N, van Iersel T. First human exposure of Org 25969, a novel agent to reverse the action of rocuronium bromide. Anesthesiology. 2005 Oct;103(4):695-703. doi: 10.1097/00000542-200510000-00007. PMID 16192761
- Sorgenfrei IF, Norrild K, Larsen PB, Stensballe J, Ostergaard D, Prins ME, Viby-Mogensen J. Reversal of rocuronium-induced neuromuscular block by the selective relaxant binding agent sugammadex: a dose-finding and safety study. Anesthesiology. 2006 Apr;104(4):667-74. doi: 10.1097/00000542-200604000-00009. PMID 16571960
- Plaud B, Meretoja O, Hofmockel R, Raft J, Stoddart PA, van Kuijk JH, Hermens Y, Mirakhur RK. Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. Anesthesiology. 2009 Feb;110(2):284-94. doi: 10.1097/ALN.0b013e318194caaa. PMID 19194156
- Meibohm B, Laer S, Panetta JC, Barrett JS. Population pharmacokinetic studies in pediatrics: issues in design and analysis. AAPS J. 2005 Oct 5;7(2):E475-87. doi: 10.1208/aapsj070248. PMID 16353925
- Olutoye OA, Yu X, Govindan K, Tjia IM, East DL, Spearman R, Garcia PJ, Coulter-Nava C, Needham J, Abrams S, Kozinetz CA, Andropoulos DB, Watcha MF. The effect of obesity on the ED(95) of propofol for loss of consciousness in children and adolescents. Anesth Analg. 2012 Jul;115(1):147-53. doi: 10.1213/ANE.0b013e318256858f. Epub 2012 May 10. PMID 22575569
- Stylianou M, Flournoy N. Dose finding using the biased coin up-and-down design and isotonic regression. Biometrics. 2002 Mar;58(1):171-7. doi: 10.1111/j.0006-341x.2002.00171.x. PMID 11890313
Идентификаторы
NCT: NCT06575036 · 2308-161-1461