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Идёт набор NCT06488807

Treatment of Perioperative Neurocognitive Disorders With Olfactory Enrichment

Без фазы С лечением Perioperative Neurocognitive Disorder

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: Olfactory Enrichment, Sham.
Кому может быть актуально
Состояния в реестре: Perioperative Neurocognitive Disorder. Базовые параметры: от 65 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

Treatment of Perioperative Neurocognitive Disorders With Olfactory Enrichment: Study Protocol for a Randomized Controlled Trial

Обзор

Perioperative neurocognitive disorder (PND) is one of the most common postoperative complications among elderly patients. However, the mechanism and targeted intervention of PND remains unclear. Our previous clinical studies demonstrated the association between olfactory impairment and PND. Moreover, our translational studies showed that anesthesia/surgery induced olfactory impairment and caused cognitive impairment in mice and olfactory enrichment could prevent the anesthesia/surgery-induced cognitive impairment. However, there was no clinical investigation to determine whether olfactory enrichment can mitigate PND in elderly patients. Therefore, we propose determining whether olfactory enrichment can prevent and/or treat PND in elderly patients.

Подробное описание

The study will be a double-blinded, randomized controlled trial. Participants (65 years old or older) undergoing scheduled orthopaedic surgery (≥2 hours, under general anesthesia) will be randomized to either olfactory enrichment group or sham group. Participants in olfactory enrichment group will receive olfactory enrichment with a dispenser twice sessions per day on preoperative day 1-3 and postoperative day 1-3 (30 min per session, 4 odors for each session) while participants in sham group will be equipped with the same pattern except that water will be used in the dispenser. Participants will be assessed twice daily by a research assistant blinded to allocation. The primary outcome will be the incidence of postoperative delirium measured by the Confusion Assessment Method on postoperative days 1, 2 and 3. The secondary outcomes will be the severity of postoperative delirium, cognitive function, plasma Tau-PT217 level, and olfactory function.

Вмешательства

  • Другое Olfactory Enrichment
    Each participant will be equipped with an electrical odor dispenser which allowed to distribute 8 odors (grapefruit, lavender, lemon, peppermint, menthol, tangerine, green tea, and bergamot). The choice of odors was guided by (1) pleasantness of the odors, (2) presence of slight trigeminal activation in some of the odors, e.g., peppermint, (3) evaporation characteristics, so that the odors would last for the duration of the experiment, (4) technical issues mostly in terms of compatibility with t
  • Другое Sham
    The containers provided to the sham group will be odorless. The odor containers and labels will appear identical to those used in the olfactory enrichment group.

Первичные конечные точки

  • Incidence of postoperative delirium [Срок оценки: at baseline and postoperative day 1 to 3]
Вторичные конечные точки (1)
  • Incidence of delayed neurocognitive recovery and postoperative neurocognitive disorder [Срок оценки: at baseline, on 21 days and 6 months after anesthesia/surgery]

Критерии участия

Критерии включения

  • Age ≥65 years old.
  • Having a scheduled surgery (≥2 hours, general anesthesia) (e.g., total hip replacement, toal knee replacement, open reduction and internal fixation of hip and lumbar spine).
  • Being able to complete neuropsychological tests, 3D-CAM and CAM-S.
  • Chinese Mandarin as their native language.
  • Edmonton frailty scale (EFS) score ≥ 6.

Критерии исключения

  • Having delirium, assessed by 3D-CAM, before surgery.
  • Having a brain tumour, stroke or mental disorders (eg, major depressive disorder or dementia).
  • Participating in other clinical studies at the time of screening.
  • Unwillingness to comply with the protocol or procedures.

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
Лечение

Центры проведения

Китай · 1 центр
  • Shanghai Tenth People's Hospital — Шанхай

Публикации

  • Mei X, Wang J, Ni Z, Wang Y, Zhao B, Sessler DI, Xie Z, Shen Y. Effects of olfactory enrichment on perioperative neurocognitive disorders in elderly patients undergoing orthopedic surgery: a study protocol of a multi-center randomized controlled trial. Trials. 2025 Sep 26;26(1):363. doi: 10.1186/s13063-025-09109-w. PMID 41013688

Идентификаторы

NCT: NCT06488807 · dsyy008

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗