Cerebral and Spinal Protection of Xenon Post-conditioning in Patients Undergoing Aortic Dissection Repair
12 мая 2016 г. обновлено: WeiPing Cheng, Beijing Anzhen Hospital
With more and more people developing hypertension and atherosclerosis, the morbidity rate of Acute Aortic Dissection（AAD） has been increasing. Emergency surgery is the main treatment for Acute Aortic Dissection. However the secondary injury caused by reperfusion of spinal cord could lead to Catastrophic complications,such as paraplegia, hemiplegia or even death. So spinal protection is always the hot topic in clinical research.
Xenon is an ideal anesthetic gases with the following features,fast onset of action, stable hemodynamics, clean and non-toxic.The animal researches have showed the protective effects of xenon to alleviate the ischemia-reperfusion injury of the nervous system.Those clues suggest that Xenon may have the potential protection of spinal cord in patients undergoing aortic dissection repair.In order to clarify this hypothesis, the investigators designed this randomized, controlled clinic trial to evaluate the protection of Xenon against spinal cord ischemia-reperfusion injury and the potential mechanisms
Обзор исследования
Тип исследования
Интервенционный
Регистрация (Ожидаемый)
120
Фаза
- Непригодный
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 60 лет (Взрослый)
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Patients doing selective operation of Bentall and Sun's or partial aortic arch replacement
- Patients doing selective operation of the full chest and abdominal aorta replacement
Exclusion Criteria:
- Emergency patient
- Patients with severe mental and neurological dysfunction
- Patients with severe hearing and visual impairment
- Illiteracy or patients can't cooperate with doing the cognitive function score
- Patients with severe cardiac insufficiency
- critically ill or dying patients
- Patients refuse to sign the informed consent
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: Control group（Ascending aorta）
undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair
|
|
|
Экспериментальный: Xenon Post-conditioning
undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
mini mental state examination
Временное ограничение: 18h before the surgery
|
18h before the surgery
|
|
NIHSS's score
Временное ограничение: the 1st day after the surgery
|
the 1st day after the surgery
|
|
ASIA impairment scale（ASIA's score ）
Временное ограничение: 18h before the surgery
|
18h before the surgery
|
|
males
Временное ограничение: 18h before the surgery
|
18h before the surgery
|
|
age
Временное ограничение: 18h before the surgery
|
18h before the surgery
|
|
height
Временное ограничение: 18h before the surgery
|
18h before the surgery
|
|
weight
Временное ограничение: 18h before the surgery
|
18h before the surgery
|
|
History of Smoking
Временное ограничение: 18h before the surgery
|
18h before the surgery
|
|
History of Hypertension
Временное ограничение: 18h before the surgery
|
18h before the surgery
|
|
History of Diabetes Mellitus
Временное ограничение: 18h before the surgery
|
18h before the surgery
|
|
New York Heart Association Heart function score
Временное ограничение: 18h before the surgery
|
18h before the surgery
|
|
duration of cardiopulmonary bypass (CPB)
Временное ограничение: 1h after the surgery
|
1h after the surgery
|
|
duration of Aortic cross-clamping
Временное ограничение: 1h after the surgery
|
1h after the surgery
|
|
duration of low flow in CPB
Временное ограничение: 1h after the surgery
|
1h after the surgery
|
|
duration of stopping the circulation
Временное ограничение: 1h after the surgery
|
1h after the surgery
|
|
the lowest nasopharyngeal temperature
Временное ограничение: 1h after the surgery
|
1h after the surgery
|
|
the lowest rectal temperature
Временное ограничение: 1h after the surgery
|
1h after the surgery
|
|
duration of surgery
Временное ограничение: 1h after the surgery
|
1h after the surgery
|
|
duration of recovering of consciousness from the end of the surgery
Временное ограничение: 3 days after the surgery
|
3 days after the surgery
|
|
duration of extubation from the end of the surgery
Временное ограничение: 3 days after the surgery
|
3 days after the surgery
|
|
duration in the ICU
Временное ограничение: 15 days after the surgery
|
15 days after the surgery
|
|
days in hospital
Временное ограничение: 15 days after leaving hospital
|
15 days after leaving hospital
|
|
pulmonary infection
Временное ограничение: 15 days after the surgery
|
15 days after the surgery
|
|
plasma S100β
Временное ограничение: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
plasma neuron specific enolase,
Временное ограничение: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
plasma myelin basic protein(MBP)
Временное ограничение: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
plasma glial fibrillary acidic protein (GFAP)
Временное ограничение: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
Cerebrospinal fluid(CSF) S100β
Временное ограничение: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF neuron specific enolase(NSE),
Временное ограничение: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF MBP
Временное ограничение: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF GFAP
Временное ограничение: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF Tumor Necrosis Factor-α(TNF-α)
Временное ограничение: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF interleukin-10 (IL-10)
Временное ограничение: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF IL-6
Временное ограничение: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF IL-2
Временное ограничение: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
somatosensory evoked potential(SEP)
Временное ограничение: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
MEP
Временное ограничение: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
Mini mental state ex amination
Временное ограничение: the 7th day after the surgery
|
the 7th day after the surgery
|
|
NIHSS's score
Временное ограничение: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
NIHSS's score
Временное ограничение: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
ASIA's score
Временное ограничение: the 1st day after the surgery
|
the 1st day after the surgery
|
|
ASIA's score
Временное ограничение: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
ASIA's score
Временное ограничение: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma S100β
Временное ограничение: immediately the end of surgery
|
immediately the end of surgery
|
|
plasma S100β
Временное ограничение: the 1st day after the surgery
|
the 1st day after the surgery
|
|
plasma S100β
Временное ограничение: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma S100β
Временное ограничение: the 7th day after the surgery
|
the 7th day after the surgery
|
|
plasma neuron specific enolase,
Временное ограничение: immediately the end of surgery
|
immediately the end of surgery
|
|
plasma neuron specific enolase,
Временное ограничение: the 1st day after the surgery
|
the 1st day after the surgery
|
|
plasma neuron specific enolase,
Временное ограничение: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma neuron specific enolase,
Временное ограничение: the 7th day after the surgery
|
the 7th day after the surgery
|
|
plasma MBP
Временное ограничение: immediately the end of surgery
|
immediately the end of surgery
|
|
plasma MBP
Временное ограничение: the 1st day after the surgery
|
the 1st day after the surgery
|
|
plasma MBP
Временное ограничение: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma MBP
Временное ограничение: the 7th day after the surgery
|
the 7th day after the surgery
|
|
plasma GFAP
Временное ограничение: immediately the end of surgery
|
immediately the end of surgery
|
|
plasma GFAP
Временное ограничение: the 1st day after the surgery
|
the 1st day after the surgery
|
|
plasma GFAP
Временное ограничение: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma GFAP
Временное ограничение: the 7th day after the surgery
|
the 7th day after the surgery
|
|
CSF S100β
Временное ограничение: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF S100β
Временное ограничение: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF S100β
Временное ограничение: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF S100β
Временное ограничение: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF neuron specific enolase,
Временное ограничение: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF neuron specific enolase,
Временное ограничение: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF neuron specific enolase,
Временное ограничение: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF neuron specific enolase,
Временное ограничение: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF MBP
Временное ограничение: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF MBP
Временное ограничение: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF MBP
Временное ограничение: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF MBP
Временное ограничение: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF GFAP
Временное ограничение: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF GFAP
Временное ограничение: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF GFAP
Временное ограничение: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF GFAP
Временное ограничение: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF TNF-α
Временное ограничение: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF TNF-α
Временное ограничение: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF TNF-α
Временное ограничение: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF TNF-α
Временное ограничение: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF IL-10
Временное ограничение: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF IL-10
Временное ограничение: the 1st day after surgery
|
the 1st day after surgery
|
|
CSF IL-10
Временное ограничение: the 2nd day after surgery
|
the 2nd day after surgery
|
|
CSF IL-10
Временное ограничение: the 3rd day after surgery
|
the 3rd day after surgery
|
|
CSF IL-6
Временное ограничение: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF IL-6
Временное ограничение: the 1st day after surgery
|
the 1st day after surgery
|
|
CSF IL-6
Временное ограничение: the 2nd day after surgery
|
the 2nd day after surgery
|
|
CSF IL-6
Временное ограничение: the 3rd day after surgery
|
the 3rd day after surgery
|
|
CSF IL-2
Временное ограничение: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF IL-2
Временное ограничение: the 1st day after surgery
|
the 1st day after surgery
|
|
CSF IL-2
Временное ограничение: the 2nd day after surgery
|
the 2nd day after surgery
|
|
CSF IL-2
Временное ограничение: the 3rd day after surgery
|
the 3rd day after surgery
|
|
SEP
Временное ограничение: immediately after blocking the aorta
|
immediately after blocking the aorta
|
|
SEP
Временное ограничение: immediately after opening the aorta
|
immediately after opening the aorta
|
|
SEP
Временное ограничение: immediately the end of the surgery
|
immediately the end of the surgery
|
|
SEP
Временное ограничение: the 4th hour after back to ICU
|
the 4th hour after back to ICU
|
|
MEP
Временное ограничение: immediately after blocking the aorta
|
immediately after blocking the aorta
|
|
MEP
Временное ограничение: immediately after opening the aorta
|
immediately after opening the aorta
|
|
MEP
Временное ограничение: immediately the end of the surgery
|
immediately the end of the surgery
|
|
MEP
Временное ограничение: the 4th hour after back to ICU
|
the 4th hour after back to ICU
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: WeiPing Cheng, master, Chief Physician，Professor
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 февраля 2016 г.
Первичное завершение (Ожидаемый)
1 июля 2018 г.
Завершение исследования (Ожидаемый)
1 сентября 2018 г.
Даты регистрации исследования
Первый отправленный
25 апреля 2016 г.
Впервые представлено, что соответствует критериям контроля качества
12 мая 2016 г.
Первый опубликованный (Оценивать)
17 мая 2016 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
17 мая 2016 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
12 мая 2016 г.
Последняя проверка
1 мая 2016 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- WCheng 2014-8-24
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕ РЕШЕНО
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования xenon
-
RWTH Aachen UniversityПрекращено