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Идёт набор NCT05895019

Effects of Propofol on Brain Function in Patients With Parkinson's Disease

— Наблюдательное PD - Parkinson's Disease

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.
Кому может быть актуально
Состояния в реестре: PD - Parkinson's Disease. Базовые параметры: 18 лет — 80 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
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Обзор

Propofol is a short-acting general anesthetic drug commonly used in clinical practice, with rapid clinical onset of action, amnesic, anxiolytic, antiepileptic, and muscle relaxant effects. The lack of natural antioxidants in patients with Parkinson's disease and propofol's ability to protect the brain by inhibiting oxidative stress, its pharmacokinetic and pharmacodynamic properties make propofol a suitable anesthetic drug for functional stereotactic surgery in patients with Parkinson's disease. However, changes in brain functional status during propofol anesthesia in Parkinson's patients are unknown. There is a lack of data from extensive clinical studies to support the need for propofol dosing during induction of anesthesia compared with non-Parkinson patients. This study is a prospective cohort study designed to compare the differences in propofol dosing requirements during induction of propofol anesthesia in patients with PD versus non-PD and to monitor the characteristics of altered brain functional status such as EEG and cerebral blood flow autoregulation capacity in PD versus non-PD patients during the perioperative period.

Вмешательства

  • Препарат Propofol
    Propofol was administered using TCI pump induction with a starting target effect concentration of 1.0ug/ml. The target concentration was increased by 0.2-0.5ug/ml if the patient did not reach unconsciousness after 1 min of stabilization of the target concentration. The propofol concentration recorded at this time was the target concentration the patient was induced to unconsciousness. The state of consciousness was tested every 60 s by the investigator, and clinical trial data were collected for

Первичные конечные точки

  • Propofol Dose [Срок оценки: During the trial(up to 30 minutes for each subject)]
Вторичные конечные точки (4)
  • Feature extraction of EEG Signals [Срок оценки: During the trial(up to 3 hours for each subject)]
  • Feature Extraction of EEG Signals [Срок оценки: During the trial(up to 3 days for each subject)]
  • Cerebral Autoregulation [Срок оценки: During the trial(up to 3hours for each subject)]
  • Patient Satisfaction with Sedation [Срок оценки: During the trial(up to 3 days for each subject)]

Критерии участия

Критерии включения

PD group:

  • age 18-80 years, ASA class I-III, proposed bilateral DBS surgery;
  • primary PD, or hereditary PD, various genotypes of PD, responding well to compounded levodopa;
  • informed consent obtained;

Non-PD group:

  • age 18-80 years, ASA class I-III, proposed non-neurosurgical non-cardiac surgery;
  • no previous clearly diagnosed neurological disease or neurological dysfunction;
  • informed consent obtained.

Критерии исключения

  • Obstructive sleep apnea;
  • BMI > 30kg/m2;
  • Estimated difficult airway;
  • Patients with prior allergy to anesthetic drugs;
  • Serious dysfunction of important organs (i.e. heart failure, renal or liver dysfunction);
  • Patients with craniocerebral trauma or craniocerebral operation history resulting in incomplete skull or brain parenchyma defect;
  • Patients with alcohol or drug addiction.

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Beijing Tiantan Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT05895019 · ywn20220901

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗