The Clinical Effect of Sugammadex Sodium (Domestic) for Antagonizing Neuromuscular Blockade After Thoracic Surgery

Официальное название

An Observational Study on the Clinical Effect of Sugammadex Sodium (Domestic) for Antagonizing Neuromuscular Blockade After Thoracic Surgery

Обзор

This study aims to compare the use of sugammadex (domestic) and neostigmine for antagonism after thoracic surgery, and observe the effect of sugammadex (domestic) on neuromuscular blockade antagonism after thoracic surgery, in order to provide a basis for optimizing the use of muscle relaxants and their antagonists during anesthesia.

Подробное описание

All patients were well prepared preoperatively, and vital signs monitoring and accelerated muscle relaxation monitor and TOF monitoring of muscle relaxation were improved after admission. General anaesthesia was induced and maintained by an experienced anaesthesiologist according to the routine drug administration protocol. The neuromuscular blocking drug was limited to rocuronium bromide at an induction dose of 0.6 mg/kg. Anaesthesia was induced with intravenous propofol and maintained with sevoflurane, and rocuronium bromide 0.15 mg/kg. At the end of surgery when the patient's degree of neuromuscular blockade spontaneously recovered to T2 reappearance, the neuromuscular blocking effect of rocuronium bromide was reversed by intravenous rapid injection of sugammadex (domestic) injection or neostigmine within 10 s. The dose of sugammadex (domestic) was 2 mg/kg, and neostigmine 50 μg/kg. Information on dosage and time of neuromuscular blocking medication was recorded, and the patients were recorded at the end of the surgery. Neuromuscular function and clinical performance after reversal with sugammadex (domestic) at the end of the procedure, recording the recovery time of neuromuscular function, extubation time, and time of leaving the room.

Вмешательства

• Препарат SUGAMMADEX SODIUM 100 Mg in 1 mL
  The dose of Sugammadex Sodium 100 Mg in 1 mL is 2mg/kg
• Препарат Neostigmine
  Neostigmine is 50 μg/kg

Первичные конечные точки

• Muscle relaxation recovery time [Срок оценки: Usually from half an hour to several hours（depending on the length of the procedure）]

Критерии участия

Критерии включения

• Patients who undergo elective lung surgery under general anesthesia and require endotracheal intubation;
• Age>18 years old, gender not limited;
• American Society of Anesthesiologists ASA Level I-III;
• Use rocuronium bromide for neuromuscular blockade;
• The patient voluntarily participated in the trial.

Критерии исключения

• The patient explicitly refused to participate in this trial;
• Family history of malignant hyperthermia, patients with allergies to sodium sulbactam, neostigmine ingredients and their excipients, and patients with allergies to drugs used during general anesthesia;
• Patients with tracheal malformations or suspected difficult airways, coagulation dysfunction, severe liver and kidney dysfunction, and severe lung disease;
• Patients who are not extubated and sent to the ward or ICU after surgery;
• The researchers believe that patients with any other unfavorable factors to participate in this trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine — Yiwu

Идентификаторы

NCT: NCT06334562 · KY-2023-112

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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