Идёт набор NCT07655817

Oral Versus Intravenous Magnesium on Emergence Delirium

Фаза II / Фаза III С лечением Magnesium Emergence Delirium Children Adenotonsillectomy

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: Magnesium glycinate, Magnesium sulfate injection, Oral juice and intravenous saline.
Кому может быть актуально: Состояния в реестре: Magnesium, Emergence Delirium, Children, Adenotonsillectomy. Базовые параметры: 4 лет — 7 лет · 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: 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 Oral Versus Intravenous Magnesium on Emergence Delirium in Children Undergoing Adenotonsillectomy: A Two-Center, Randomized, Double-Blind, Placebo-Controlled Study

Обзор

This prospective randomized controlled study will be conducted to compare the effects of preoperative oral magnesium and intraoperative IV magnesium on the incidence and severity of emergence delirium in children undergoing adenotonsillectomy using sevoflurane anesthesia.

Подробное описание

Magnesium is a non-anesthetic N-methyl-D-aspartate receptor antagonist, which is as an anesthetic- and analgesic-sparing medication, with controversial clinical effectiveness.

Regarding its use as a preventive measure against emergence delirium in children, only intraoperative IV route was studied and the results of previous reports were inconsistent.

Oral magnesium syrup is a common drug used for enzyme activation, muscle and bone health, with calming effect and central nervous system supporting value.

In this novel study, we will compare the use of magnesium via two different routes, either oral route before surgery or IV route after sevoflurane induction, regarding their preventive value against the occurrence of emergence delirium in children undergoing adenotonsillectomy. Given the fact that preoperative anxiety and parent separation are predictors for emergence delirium, the calming effect, sleep promoting value of oral magnesium that may be obtained before anesthetic induction together with its peri-operative analgesic effects may suggest a prophylactic benefit against emergence delirium. So, we hypothesize that either oral or IV magnesium therapy may decrease the incidence of emergence delirium in this setting.

Вмешательства

Препарат Magnesium glycinate
cases will receive preoperative oral magnesium dose of 150 mg (10 ml of Magnesium Glycinate Liquid Trace syrup) at two hours before surgery, and will receive intraoperative IV (10 ml) of saline 0.9% over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure.
Препарат Magnesium sulfate injection
cases will receive oral lemon juice (10 ml) at two hours before surgery, and will receive intraoperative IV magnesium sulfate dose of 30 mg/kg (diluted in saline to a total volume of 10 ml) over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure.
Другое Oral juice and intravenous saline
cases will receive oral lemon juice (10 ml) at two hours before surgery and will receive intraoperative IV (10 ml) of saline 0.9% over 10 minutes (1ml/min) after induction of anesthesia and before the start of surgical procedure.

Первичные конечные точки

Incidence of emergence delirium [Срок оценки: Up to 1 hour after surgery.]

Вторичные конечные точки (9)

Severity of emergence delirium [Срок оценки: Up to 1 hour after surgery.]
Postoperative pain [Срок оценки: Up to 1 hour after surgery.]
Parental separation anxiety [Срок оценки: Perioperative]
Mask acceptance [Срок оценки: Perioperative]
The total dose of rescue propofol [Срок оценки: Up to 1 hour after surgery.]
The total dose of rescue fentanyl [Срок оценки: Up to 1 hour after surgery.]
Extubation time [Срок оценки: End of surgery.]
Negative behavior changes [Срок оценки: 24 hours after surgery.]
Side effects [Срок оценки: Up to 1 hour after surgery.]

Критерии участия

Критерии включения

Children aged 4 to 7 years
American Society of Anesthesiologist (ASA) Status I or II
Planned for an adenotonsillectomy procedure under sevoflurane general anesthesia.