Cerebral and Spinal Protection of Xenon Post-conditioning in Patients Undergoing Aortic Dissection Repair
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 主要终点
- CSF IL-10
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Xenon Post-conditioning
undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair
干预措施: xenon (Drug)
结局指标
主要结局
CSF IL-10
时间窗: the 3rd day after surgery
mini mental state examination
时间窗: 18h before the surgery
days in hospital
时间窗: 15 days after leaving hospital
plasma S100β
时间窗: the 7th day after the surgery
Cerebrospinal fluid(CSF) S100β
时间窗: immediately after anesthesia induction
CSF IL-2
时间窗: the 3rd day after surgery
height
时间窗: 18h before the surgery
duration of cardiopulmonary bypass (CPB)
时间窗: 1h after the surgery
the lowest nasopharyngeal temperature
时间窗: 1h after the surgery
duration of extubation from the end of the surgery
时间窗: 3 days after the surgery
pulmonary infection
时间窗: 15 days after the surgery
plasma neuron specific enolase,
时间窗: the 7th day after the surgery
plasma glial fibrillary acidic protein (GFAP)
时间窗: immediately after anesthesia induction
somatosensory evoked potential(SEP)
时间窗: immediately after anesthesia induction
CSF S100β
时间窗: the 3rd day after the surgery
CSF neuron specific enolase,
时间窗: the 3rd day after the surgery
males
时间窗: 18h before the surgery
History of Hypertension
时间窗: 18h before the surgery
duration of Aortic cross-clamping
时间窗: 1h after the surgery
duration of recovering of consciousness from the end of the surgery
时间窗: 3 days after the surgery
duration in the ICU
时间窗: 15 days after the surgery
CSF IL-6
时间窗: the 3rd day after surgery
plasma GFAP
时间窗: the 7th day after the surgery
NIHSS's score
时间窗: the 3rd day after the surgery
ASIA impairment scale（ASIA's score ）
时间窗: 18h before the surgery
History of Diabetes Mellitus
时间窗: 18h before the surgery
New York Heart Association Heart function score
时间窗: 18h before the surgery
duration of stopping the circulation
时间窗: 1h after the surgery
the lowest rectal temperature
时间窗: 1h after the surgery
duration of surgery
时间窗: 1h after the surgery
age
时间窗: 18h before the surgery
weight
时间窗: 18h before the surgery
History of Smoking
时间窗: 18h before the surgery
duration of low flow in CPB
时间窗: 1h after the surgery
plasma myelin basic protein(MBP)
时间窗: immediately after anesthesia induction
CSF GFAP
时间窗: the 3rd day after the surgery
MEP
时间窗: the 4th hour after back to ICU
Mini mental state ex amination
时间窗: the 7th day after the surgery
CSF TNF-α
时间窗: the 3rd day after the surgery
plasma MBP
时间窗: the 7th day after the surgery
ASIA's score
时间窗: the 3rd day after the surgery
CSF neuron specific enolase(NSE),
时间窗: immediately after anesthesia induction
CSF MBP
时间窗: the 3rd day after the surgery
CSF Tumor Necrosis Factor-α(TNF-α)
时间窗: immediately after anesthesia induction
CSF interleukin-10 (IL-10)
时间窗: immediately after anesthesia induction
SEP
时间窗: the 4th hour after back to ICU
次要结局
未报告次要终点
研究者
WeiPing Cheng
Professor；Chief Physician
Beijing Anzhen Hospital