MInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES)
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: Dexmedetomidine, Placebo.
- Кому может быть актуально
- Состояния в реестре: Major Abdominal Surgery, Postoperative Delirium (POD), Sleep Disturbances, Intranasal Dexmedetomidine. Базовые параметры: 65 лет — 90 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
- Список центров уточняется — проверьте первичный протокол.
- 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
Minimizing Delirium With Nasal Dexmedetomidine-Induced Sleep in Older Patients Undergoing Major Abdominal Surgery: : a Randomized, Double-blind, Placebo-controlled Trial
Обзор
This study aims to determine whether, compared with placebo, the nighttime self-administration of a nasal dexmedetomidine is effective at inducing sleep and preventing postoperative delirium in high-risk patients.
Подробное описание
Delirium is an acute, short-term brain dysfunction characterized by fluctuating consciousness, cognitive decline, inattention, and sleep-wake cycle disruption. Postoperative delirium (POD), occurring predominantly within the first postoperative week (especially days 3-5 in elderly patients), affects 11-45% of older adults after major surgery. POD prolongs hospitalization, increases morbidity and mortality 5,65,6, yet its pathophysiology remains unclear, and evidence-based pharmacological prevention is lacking. Thus, effective POD prevention strategies are urgently needed.
Preoperative anxiety, a modifiable risk factor for POD, affects 11-80% of surgical patients. It contributes to sleep disturbances (e.g., insomnia, early awakening), which may exacerbate POD via neuroendocrine and immune dysregulation. However, benzodiazepines (e.g., lorazepam, diazepam, midazolam), though effective anxiolytics, increase delirium risk and are contraindicated preoperatively per current guidelines.
Dexmedetomidine (DEX), a selective α2-adrenoceptor agonist, induces physiological non-REM sleep without respiratory depression or hemodynamic instability. Its nasal formulation offers high bioavailability (82%), ease of administration, and is approved in China for preoperative sedation/anxiety. While intravenous (IV) DEX reduces POD in predominant ICU settings, its use in general wards remains unexplored. Preclinical studies suggest DEX enhances glymphatic clearance and exerts anti-inflammatory effects, potentially mitigating the development of POD. This study thus hypothesize that a nasal dexmedetomidine is effective at inducing sleep and preventing postoperative delirium in high-risk patient population. We set to demonstrate that to determine whether, compared with placebo, the nighttime self-administration of a nasal dexmedetomidine is effective at inducing sleep and preventing postoperative delirium in older patients undergoing major abdominal surgery.
Вмешательства
- Препарат Dexmedetomidine
Intranasal dexmedetomidine (100 µg total: 4 sprays, 25 µg/spray; Hengrui Medicine, China) self-administered preoperatively (\~9 PM) and optionally on the night of surgery (patient decides dose: 0, 2 sprays, or 4 sprays). - Препарат Placebo
Intranasal water for injection (4 sprays, identical volume as nasal dexmedetomidine; Hengrui Medicine, China) self-administered preoperatively (\~9 PM) and optionally on the night of surgery (patient decides dose: 0, 2 sprays, or 4 sprays).
Первичные конечные точки
- Incidence of postoperative delirium [Срок оценки: Up to postoperative day (POD) 7 or discharge (whichever first).]
Вторичные конечные точки (10)
- Delirium severity [Срок оценки: Up to postoperative day (POD) 7 or discharge (whichever first)]
- Physical activity [Срок оценки: Up to postoperative day (POD) 3]
- Sleep quality [Срок оценки: Up to postoperative day (POD) 3]
- Anxiety [Срок оценки: Up to postoperative day (POD) 3]
- Pain intensity [Срок оценки: Up to postoperative day (POD) 3]
- Opioid consumption [Срок оценки: Up to postoperative day (POD) 3]
- Health related quality of life [Срок оценки: On postoperative day (POD) 3 and 30]
- Quality of Recovery [Срок оценки: Up to postoperative day (POD) 3]
- Postoperative Nausea and Vomiting [Срок оценки: Up to postoperative day (POD) 3]
- Post-anesthesia Care Unit (PACU) length of stay [Срок оценки: Up to postoperative day (POD) 1]
Критерии участия
Критерии включения
- Aged 65-90 years
- Scheduled for a major abdominal surgery with estimated surgery time ≥ 2 hours
Критерии исключения
- Blind, deafness or the inability to speak mandarin
- Allergy to dexmedetomidine.
- Renal and liver failure requiring dialysis or Child-Pugh score > 5
- Follow-up difficulties (i.e. active substance abuse, psychotic disorder, homelessness)
- Previous major abdominal or cardiac surgery within 1 year of surgical procedure
- Chronic therapy with benzodiazepines and/or antipsychotics. Severe deficit due to structural or anoxic brain damage
- Body weight < 35 kg
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
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07538284 · 2025ZSLYEC-227