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Идёт набор NCT06575530

Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation

Фаза IV С лечением Effect of Drug Adverse Drug Event Mechanical Ventilation Complication Critical Illness

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: Remimazolam Besylate, Dexmedetomidine Hydrochloride.
Кому может быть актуально
Состояния в реестре: Effect of Drug, Adverse Drug Event, Mechanical Ventilation Complication, Critical Illness. Базовые параметры: 18 лет — 64 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
Китай
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

Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation: A Randomized Controlled Trial

Обзор

A multi-center, prospective, randomized, double-blind, active-controlled, no-inferiority clinical trial conducted across 5 tertiary medical centers in China. The objective of this RCT is to evaluate the sedative efficacy and safety profile of remimazolam besylate compared with dexmedetomidine in patients requiring mechanical ventilation following non-cardiac surgery. The study hypothesized that remimazolam besylate is non-inferior to dexmedetomidine regarding the primary efficacy outcome.

Вмешательства

  • Препарат Remimazolam Besylate
    patients will be sedated with remimazolam via intravenous pump on the day of ICU admission, the dosage will titrate with the depth of sedation evaluated with RASS. If the target sedation depth could not to achieved within the prespecified maximum dose range of remimazolam, a standardized rescue sedation protocol will intiated as follows: an intravenous bolus of propofol at 0.2mg/kg will administered. Sedation depth will evaluated 5 minutes post-injection. The identical dose of propofol bolus wil
  • Препарат Dexmedetomidine Hydrochloride
    patients will be sedated with dexmedetomidine hydrochloride via intravenous pump on the day of ICU admission, the dosage will titrate with the depth of sedation evaluated with RASS. If the target sedation depth could not to achieved within the prespecified maximum dose range of remimazolam, a standardized rescue sedation protocol will intiated as follows: an intravenous bolus of propofol at 0.2mg/kg will administered. Sedation depth will evaluated 5 minutes post-injection. The identical dose of

Первичные конечные точки

  • Percentage of time in optimal sedation [Срок оценки: Through the useage of sedative drugs in the ICU, an average of 3 days]
Вторичные конечные точки (12)
  • Ventilation free days [Срок оценки: Through the initiation of enrollment to 28 days, an average of 1 day]
  • Dosage of rescue sedatives [Срок оценки: Through the useage of sedative drugs in the ICU, an average of 3 days]
  • Frequency of rescue sedatives [Срок оценки: Through the useage of sedative drugs in the ICU, an average of 3 days]
  • Delirium incidence [Срок оценки: Through the ICU stay, an average of 3 days]
  • post-sedation extubation time [Срок оценки: From ICU admission to extubation, an average of 3 days]
  • Re-mechanical ventilation incidence after weaning and extubation [Срок оценки: Through the ICU stay, an average of 3 days]
  • Proportion of different oxygen therapies post-extubation [Срок оценки: Through the ICU stay, an average of 3 days]
  • Pain scores during the first 3 postoperative days [Срок оценки: The first 3 days of ICU stay, an average of 3 days]
  • Sleep quality scores on the day of ICU discharge [Срок оценки: The day transfer out of ICU, an average of 1day]
  • Cognitive assessment scores on postoperative day 60 [Срок оценки: Day 60 after surgery, an average of 1 day]
  • Sleep quality scores on postoperative day 60 [Срок оценки: Day 60 after surgery, an average of 1 day]
  • ICU LOS [Срок оценки: The day the patient transfer out of ICU, an average of 1 day]

Критерии участия

Критерии включения

  • Aged between 18 and 64 years
  • Scheduled to undergo elective non-cardiac surgery
  • Planned for general anesthesia
  • With or without combined regional nerve blockade
  • Admitted to the ICU with endotracheal intubation post-surgery
  • With an anticipated duration of postoperative mechanical ventilation greater than 24 hours
  • Clinically requiring light sedation( target RASS score 0 to -2)

Критерии исключения

  • Undergoing intracranial surgery, or having a history of severe neurological or spinal cord diseases
  • Pre-existing history of schizophrenia, epilepsy, or Parkinson's disease
  • Inability to communicate preoperatively due to coma, severe dementia, or language barriers
  • Preoperative .cardiac insufficiency or severe cardiac arrhythmias
  • Severe hepatic impariment( Child-Pugh class C)
  • Severe renal impariment
  • Preoperative( within 24 hours prior to surgery) or intraoperative administration of dexmedetomidine or remimazolam
  • Pregnancy or lactation
  • Participation in any clinical trial involving investigational drugs within 30 days prior to enrollment
  • Any other conditions deemed by the investigators to render the patient unsuitable for study participation
  • Refusal to provide written informed consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Beijing Shijitan Hospital.CMU — Пекин

Идентификаторы

NCT: NCT06575530 · IIT2024-001-002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗