Идёт набор NCT06717490

Magnesium Sulfate and Postoperative Hypercoagulability in Laparoscopic Gynecological Surgeries

Без фазы С лечением Magnesium Sulfate Thromboelastometry

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 sulphate, Placebo Drug.
Кому может быть актуально: Состояния в реестре: Magnesium Sulfate, Thromboelastometry. 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: Греция
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 Magnesium Sulfate on Postoperative Hypercoagulability Using Thromboelastometry in Laparoscopic Gynecological Surgeries

Обзор

This will be a prospective randomized, double-blind study, aiming at investigating the effects of magnesium sulfate on postoperative hypercoagulability in patients undergoing laparoscopic gynecological surgeries under general anesthesia

Подробное описание

This randomized, double-blind, controlled study investigates the effects of magnesium sulfate on postoperative hypercoagulability in patients undergoing laparoscopic gynecological surgeries under general anesthesia. Using thromboelastometry, the study aims to assess the impact of magnesium sulfate on blood coagulation parameters. Patients are divided into two groups, with one group receiving magnesium sulfate and the other receiving normal saline. Both patients and investigators are blinded to the treatment allocation. The study will analyze clotting time, clot formation, and coagulation markers to evaluate the therapeutic potential of magnesium sulfate in reducing postoperative hypercoagulability.

Вмешательства

Препарат Magnesium sulphate
In patients allocated to the MS group, a fixed dose of magnesium sulfate diluted in a fixed volume of natural saline will be administered intravenously. Thromboelastometry will be performed pre and post magnesium administration.
Другое Placebo Drug
In patients allocated to the NS group, a fixed dose of natural saline will be administered intravenously, through a fixed volume of solution. Thromboelastometry will be performed pre and post magnesium administration.

Первичные конечные точки

Clotting Time [CT] (in seconds, measured using ROTEM) [Срок оценки: Up to six hours (first thromboelastometry will be performed immediately before magnesium administration intraoperatively, and the second thromboelastometry will be performed at the post-anesthesia care unit)]
Clot Formation Time [CFT] (in seconds, measured using ROTEM) [Срок оценки: Up to six hours (first thromboelastometry will be performed immediately before magnesium administration intraoperatively, and the second thromboelastometry will be performed at the post-anesthesia care unit)]
Maximum Clot Firmness [MCF] (in mm, measured using ROTEM) [Срок оценки: Up to six hours (first thromboelastometry will be performed immediately before magnesium administration intraoperatively, and the second thromboelastometry will be performed at the post-anesthesia care unit)]
a-angle (in degrees, measured using ROTEM) [Срок оценки: Up to six hours (first thromboelastometry will be performed immediately before magnesium administration intraoperatively, and the second thromboelastometry will be performed at the post-anesthesia care unit)]

Вторичные конечные точки (8)

Train of Four (TOF) [Срок оценки: 4 minutes (time point 0 will be at neuromuscular blocking agent administration)]
Area Under the Curve (AUC) for Nociception Index Level (NOL) [Срок оценки: Intraoperative]
Changes in INR Before and After Magnesium Administration [Срок оценки: Up to six hours (first assessment will be performed before surgery and the second assessment will be performed at the post-anesthesia care unit)]
Changes in aPTT Before and After Magnesium Administration [Срок оценки: Up to six hours (first assessment will be performed before surgery and the second assessment will be performed at the post-anesthesia care unit)]
Changes in PT Before and After Magnesium Administration [Срок оценки: Up to six hours (first assessment will be performed before surgery and the second assessment will be performed at the post-anesthesia care unit)]
Changes in Platelet Count Before and After Magnesium Administration [Срок оценки: Up to six hours (first assessment will be performed before surgery and the second assessment will be performed at the post-anesthesia care unit)]
Changes in Fibrinogen Levels Before and After Magnesium Administration [Срок оценки: Up to six hours (first assessment will be performed before surgery and the second assessment will be performed at the post-anesthesia care unit)]
Clinical thrombosis symptoms [Срок оценки: 24 hours (first assessment will be performed immediately before surgery, and the final assessment will be performed 24 hours postoperatively)]

Критерии участия

Критерии включения

ASA I and II patients
Laparoscopic gynecological surgeries
age >18 years
Patients receiving prophylactic anticoagulant therapy 12 hours before surgery based on the Caprini score
Patients receiving prophylactic anticoagulant therapy 12 hours postoperatively based on the Caprini score.