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Набор скоро начнётся NCT07109362

ERP-Based Research on the Modulation of Remimazolam on Working Memory and Brain Network Mechanisms in Glioma Patients

Без фазы С лечением Remimazolam Mild Sedation Healthy Brain and Glioma Brain

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: mild sedation.
Кому может быть актуально
Состояния в реестре: Remimazolam Mild Sedation, Healthy Brain and Glioma Brain. Базовые параметры: 18 лет — 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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Обзор

Remimazolam is a novel ultra-short-acting benzodiazepine with extensive evidence supporting its safety and efficacy in clinical anesthesia and sedation. Its perioperative use in patients with glioma is becoming increasingly common. Glioma is the most common primary intracranial tumor and is often associated with neurocognitive impairment, with memory being the most frequently affected domain. Working memory, which integrates temporary storage and information processing, serves as a cognitive workspace. Currently, the impact of anesthetics on neurocognitive function during the perioperative period in glioma patients remains underexplored. This study aims to investigate the effects of remimazolam-induced mild sedation on working memory in healthy subjects and patients with supratentorial glioma by combining behavioral and electrophysiological measurements, focusing on the relationship with the P3b event-related potential amplitude. Furthermore, it explores how remimazolam sedation influences brain network functional connectivity during the encoding, maintenance, and retrieval phases of memory in healthy individuals and patients with supratentorial glioma.

Вмешательства

  • Препарат mild sedation
    In this experiment, all subjects were administered remimazolam via a TCI pump until they reached a state of mild sedation, as indicated by a MOAA/S score of 4.

Первичные конечные точки

  • behavioral results, including reaction time and accuracy rate [Срок оценки: All participants completed the working memory test one day before the surgery.]
  • P3b event-related potential (ERP) [Срок оценки: All participants completed the working memory test one day before the surgery, with simultaneous collection of 64-channel scalp electroencephalogram (EEG).]

Критерии участия

Критерии включения

A. Healthy brain group:

  • Aged 18-65 years;
  • Native speakers of Chinese;
  • Right-handed; ④ Normal vision or corrected vision; ⑤ Healthy brain patient population scheduled for non-neurosurgical operations and anesthesia B. Glioma brain group
  • Aged 18-65 years old;
  • Native speakers of Chinese;
  • Right-handed; ④ ASA physical status I-II;
  • Normal vision or corrected vision;
  • Patients with supratentorial glioma who have primary unilateral space-occupying lesions confirmed by CT/MRI and require surgery and anesthesia.

Критерии исключения

A. Healthy brain group:

  • Allergic to remimazolam or with contraindications to remimazolam (myasthenia gravis, schizophrenia, severe depressive state);
  • History of drug abuse or alcoholism;
  • History of mental or neurological diseases that prevent cooperation in completing the trial; ④ Pregnant or lactating women;
  • Score of mini-mental state examination (MMSE) < 27; ⑥ Past history of intracranial diseases or intracranial surgery

B. Glioma brain group:

  • Receiving sedative treatment within 72 hours prior to the study;
  • Destruction of cerebral structural integrity such as open head injury or cerebral parenchyma resection;
  • Preoperative elevated intracranial pressure requiring mannitol or other intracranial pressure-lowering treatments, or preoperative radiotherapy and chemotherapy;
  • History of drug abuse or alcoholism;
  • Pregnant or lactating women; ⑥ Mini-Mental State Examination (MMSE) score < 27; ⑦ History of allergic reaction to remimazolam or having contraindications to remimazolam. Remimazolam is a national controlled drug with addictive properties and must be used under the guidance of a doctor; ⑧ Those with other mental or neurological diseases who are unable to cooperate in completing the trial; ⑨ Unsuitable for participating in this study due to other reasons.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Китай · 1 центр
  • Beijing Tiantan Hospital — Пекин

Идентификаторы

NCT: NCT07109362 · RM20250717

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗