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Идёт набор NCT06386354

Residual Neuromuscular Block in the Post-Anesthetic Unit and Postoperative Complications

— Наблюдательное Postoperative Neuromuscular Block Postoperative Complications

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: Train-of-four.
Кому может быть актуально
Состояния в реестре: Postoperative Neuromuscular Block, Postoperative Complications. 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
Испания
Следующий шаг
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Обзор

The use of neuromuscular blockers (NMB) is essential to optimize surgical conditions, ensure patient immobility during the intervention and prevent complications derived from involuntary movements. Intraoperative monitoring of neuromuscular relaxation allows the depth of neuromuscular blockade to be accurately evaluated, guaranteeing ideal conditions for the surgical team. Residual neuromuscular blockade (RNMB) is the persistence of muscle paralysis after the administration of NMB during a surgical intervention. The appearance of RNMB poses substantial challenges in the postoperative period, as it has negative repercussions for the safety and well-being of the patient.

Подробное описание

The use of neuromuscular blockers (NMB) is essential to optimize surgical conditions, ensure patient immobility during the intervention and prevent complications derived from involuntary movements. Intraoperative monitoring of neuromuscular relaxation allows the depth of neuromuscular blockade to be accurately evaluated, guaranteeing ideal conditions for the surgical team. Residual neuromuscular blockade (RNMB) is the persistence of muscle paralysis after the administration of NMB during a surgical intervention. The appearance of RNMB poses substantial challenges in the postoperative period, as it has negative repercussions for the safety and well-being of the patient. In this prospective observational study, all patients who underwent general anesthesia with neuromuscular blockade were studied consecutively to evaluate the presence of residual neuromuscular blockade and its potential consequences during hospital admission.Considering that the percentage of residual curarization is 19% (PORCzero study), with a 95% confidence interval and a 3% error margin, 236 patients are needed to accurately estimate the prevalence of residual curarization in the study population. With an expected loss proportion of 20%, the chosen sample size is 296 patients.

Вмешательства

  • Диагностический тест Train-of-four
    Patients submitted to general anesthesia with neuromuscular block will be monitored at their arrival to the Post-Anesthesia Care Unit to assess the presence of residual neuromuscular block.

Первичные конечные точки

  • Residual Neuromuscular Block [Срок оценки: 5 minutes postoperatively]
  • Residual Neuromuscular Block [Срок оценки: 8 minutes postoperatively]
Вторичные конечные точки (1)
  • Postoperative complications [Срок оценки: 30 days postoperatively]

Критерии участия

Критерии включения

  • Patient undergoing surgical intervention under general anesthesia that requires the use of neuromuscular block during the study time and that required hospital admission.
  • Informed consent signature.

Критерии исключения

  • Neuromuscular disease
  • Not having received neuromuscular block during the intervention
  • Admission to the outpatient surgery unit
  • Admission to the postoperative intensive care unit
  • Patients who signed informed consent, but postoperative data could not be collected upon arrival at the PACU.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Испания · 2 центра
  • Hospital Universitario de Gran Canaria Doctor Negrín — Las Palmas de Gran Canaria
  • Ángel Becerra — Las Palmas de Gran Canaria

Идентификаторы

NCT: NCT06386354 · 2023-464-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗