Acceleromyography Versus Electromyography for Neuromuscular Recovery Assessment at the End of Surgery
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: Simultaneous Acceleromyography and Electromyography Monitoring.
- Кому может быть актуально
- Состояния в реестре: Neuromuscular Blockade, Cholecystectomy. Базовые параметры: от 18 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
- Чили
- 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
Concordance Between Acceleromyography and Electromyography for Assessment of Neuromuscular Recovery at the End of Surgery
Обзор
This prospective observational study aims to evaluate the agreement between acceleromyography and electromyography for measuring train-of-four (TOF) ratio at the end of surgery before reversal of neuromuscular blockade. Adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia with non-depolarizing neuromuscular blockade will undergo simultaneous TOF measurements using both monitoring methods. The study will assess the agreement between the two techniques, estimate measurement bias and limits of agreement, and determine the frequency of clinically relevant disagreement that could affect assessment of neuromuscular recovery and safe extubation.
Подробное описание
Quantitative neuromuscular monitoring is recommended to reduce the incidence of residual neuromuscular blockade and its associated postoperative complications. Although electromyography is considered the current clinical reference method for objective neuromuscular monitoring, acceleromyography remains the most commonly used technique in routine clinical practice because of its availability, lower cost, and ease of use. However, acceleromyography may overestimate neuromuscular recovery, particularly when baseline normalization is not performed.
This prospective observational diagnostic agreement study will enroll adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia requiring administration of non-depolarizing neuromuscular blocking agents. At the end of surgery, before administration of neuromuscular blockade reversal agents, simultaneous train-of-four (TOF) ratio measurements will be obtained using acceleromyography and electromyography. Acceleromyography will be performed according to routine clinical practice without baseline normalization, while electromyography will serve as the reference method.
The primary objective is to evaluate the agreement between acceleromyography and electromyography measurements obtained at the end of surgery. Secondary objectives include estimating the mean bias between methods, calculating the 95% limits of agreement using Bland-Altman analysis, evaluating proportional bias, and determining the proportion of patients in whom acceleromyography indicates adequate neuromuscular recovery (TOF ≥0.9) while electromyography demonstrates residual neuromuscular blockade (TOF \<0.9).
Demographic, clinical, and anesthetic variables will also be collected. Approximately 70 participants are expected to be enrolled.
Вмешательства
- Диагностический тест Simultaneous Acceleromyography and Electromyography Monitoring
Simultaneous quantitative neuromuscular monitoring using acceleromyography and electromyography to measure the train-of-four (TOF) ratio at the end of surgery before administration of neuromuscular blockade reversal agents.
Первичные конечные точки
- Agreement Between Acceleromyography and Electromyography Train-of-Four Ratios [Срок оценки: At the end of surgery, before administration of neuromuscular blockade reversal agents]
Вторичные конечные точки (4)
- Mean Bias Between Acceleromyography and Electromyography TOF Ratios [Срок оценки: At the end of surgery, before administration of neuromuscular blockade reversal agents]
- Ninety-Five Percent Limits of Agreement Between TOF Monitoring Methods [Срок оценки: At the end of surgery, before administration of neuromuscular blockade reversal agents]
- Proportional Bias Between Acceleromyography and Electromyography TOF Ratios [Срок оценки: At the end of surgery, before administration of neuromuscular blockade reversal agents]
- Proportion of Participants With False Neuromuscular Recovery Indicated by Acceleromyography [Срок оценки: At the end of surgery, before administration of neuromuscular blockade reversal agents]
Критерии участия
Критерии включения
- Adults aged 18 years or older.
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia.
- Administration of non-depolarizing neuromuscular blocking agents.
- Written informed consent provided.
Критерии исключения
- Pre-existing neuromuscular disease.
- Upper extremity abnormalities preventing neuromuscular monitoring.
- Contraindications to neuromuscular monitoring.
- Refusal or inability to provide informed consent.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Чили · 1 центр
- Clínica Dávila — Santiago
Идентификаторы
NCT: NCT07739862 · CD2026/16