Меню
Набор скоро начнётся NCT06756178

Effect of Remimazolam Versus Dexmedetomidine on the Incidence of Delirium After Elective Cardiac Surgery with Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial

Ранняя фаза I С лечением Delirium - Postoperative

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: Propofol Group 1, Remimazolam Intervention, Dexmedetomidine Intervention.
Кому может быть актуально
Состояния в реестре: Delirium - Postoperative. 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
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

The study aims to improve the post-open heart surgery lifestyle and overall experience, as well as assess the incidence of delirium using Remimazolam and Dexmedetomidine.

Подробное описание

Delirium is an acute brain dysfunction characterized by an acute onset and fluctuating course of disturbance in attention, awareness, and cognition, It is the most common neurocognitive complication following cardiac surgery, with an incidence rate between 11% and 52%.

The occurrence of delirium correlates strongly with various short- and long-term poor outcomes following cardiac surgery, including prolonged ICU stay and hospitalization and increased risk of hospital readmission. Different risk factors contribute to delirium after cardiac surgery, including advanced age, pre-existing cognitive impairment, diabetes, history of stroke, type of surgery, extended CPB duration, and blood transfusion. Dexmedetomidine is a highly and potently selective α2-adrenoceptor agonist with anxiolytic, sedative, and analgesic properties. It has neuroprotective effects by reducing neuroinflammation, apoptosis, and blood-brain barrier injury via central α2A adrenoceptors, but it can cause hypotension and bradycardia.

Remimazolam, a new ultra-short-acting benzodiazepine, also has a faster onset of action and a higher safety profile. It was recently approved for procedural sedation and general anesthesia. Its metabolism is mainly induced by tissue esterase, independent of liver and kidney function, and its metabolites are inactive. In addition, flumazenil reverses the effects of Remimazolam in the event of adverse events, an advantage not available in non-benzodiazepines. The objective of this clinical trial is to evaluate the efficacy of Remimazolam compared with Dexmedetomidine for preventing postoperative delirium after cardiac surgery.

Вмешательства

  • Препарат Propofol Group 1
    Postoperative Use: Bolus: 10-20 mg intravenously as needed for sedation initiation. Continuous infusion: 0.3-0.5 mg/kg/hour to maintain light sedation adjusted based on clinical response.
  • Препарат Remimazolam Intervention
    Postoperative Use: Initial bolus: 5 mg intravenously upon ICU arrival. Continuous infusion: 0.2-0.3 mg/kg/hour to maintain light sedation with a maximum dose of 0.8 mg/kg/hour. Rescue sedation with propofol or midazolam will be allowed if patients become agitated or if Remimazolam is ineffective in maintaining target sedation.
  • Препарат Dexmedetomidine Intervention
    Postoperative Use: Loading dose: 0.5-1 μg/kg over 10-20 minutes after ICU arrival. Continuous infusion: 0.2-0.7 μg/kg/hour for sedation maintenance, adjusted as needed to maintain light sedation. Rescue sedation with propofol or midazolam will be administered if Dexmedetomidine fails to maintain adequate sedation or if patients become agitated.

Первичные конечные точки

  • Postoperative Delirium (POD) [Срок оценки: During the first 5 days after surgery]
Вторичные конечные точки (1)
  • Time of delirium onset and duration ,Sedation level [Срок оценки: During first 5 days after surgery]

Критерии участия

Критерии включения

  • Age ≥18 years.
  • Scheduled for cardiac surgery (CABG and/or valve replacement).
  • Elective surgery

Критерии исключения

  • Patients with known allergies to Remimazolam or Dexmedetomidine
  • Refusal to participate.
  • History of psychiatric or neurological conditions (schizophrenia, epilepsy, severe dementia, etc.).
  • Preoperative inability to communicate (severe visual/auditory dysfunction, language barriers).
  • Severe hepatic or renal dysfunction
  • Cardiopulmonary bypass time not ≥ 120 minutes
  • aortic clamping time not ≥ 90 minutes
  • Emergency surgeries
  • On preoperative mechanical ventilation and long sedation time
  • reoperated patients

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
Двойное слепое
Основная цель
Профилактика

Центры проведения

Египет · 1 центр
  • Assiut University — Asyut

Идентификаторы

NCT: NCT06756178 · Elective cardiac surgery

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗