Cerebral and Spinal Protection of Xenon Post-conditioning in Patients Undergoing Aortic Dissection Repair

Study Overview
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Brief Summary
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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

Official Title
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Cerebral and Spinal Protection of Xenon Post-conditioning in Patients Undergoing Aortic Dissection Repair

Conditions
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Aortic Dissection

Intervention / Treatment
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* Drug: xenon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group（Ascending aorta）<br>undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair | |
| Experimental: Xenon Post-conditioning<br>undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair | Drug: xenon<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mini mental state examination |  | 18h before the surgery | 
| NIHSS's score |  | the 1st day after the surgery | 
| ASIA impairment scale（ASIA's score ） |  | 18h before the surgery | 
| males |  | 18h before the surgery | 
| age |  | 18h before the surgery | 
| height |  | 18h before the surgery | 
| weight |  | 18h before the surgery | 
| History of Smoking |  | 18h before the surgery | 
| History of Hypertension |  | 18h before the surgery | 
| History of Diabetes Mellitus |  | 18h before the surgery | 
| New York Heart Association Heart function score |  | 18h before the surgery | 
| duration of cardiopulmonary bypass (CPB) |  | 1h after the surgery | 
| duration of Aortic cross-clamping |  | 1h after the surgery | 
| duration of low flow in CPB |  | 1h after the surgery | 
| duration of stopping the circulation |  | 1h after the surgery | 
| the lowest nasopharyngeal temperature |  | 1h after the surgery | 
| the lowest rectal temperature |  | 1h after the surgery | 
| duration of surgery |  | 1h after the surgery | 
| duration of recovering of consciousness from the end of the surgery |  | 3 days after the surgery | 
| duration of extubation from the end of the surgery |  | 3 days after the surgery | 
| duration in the ICU |  | 15 days after the surgery | 
| days in hospital |  | 15 days after leaving hospital | 
| pulmonary infection |  | 15 days after the surgery | 
| plasma S100β |  | immediately after anesthesia induction | 
| plasma neuron specific enolase, |  | immediately after anesthesia induction | 
| plasma myelin basic protein(MBP) |  | immediately after anesthesia induction | 
| plasma glial fibrillary acidic protein (GFAP) |  | immediately after anesthesia induction | 
| Cerebrospinal fluid(CSF) S100β |  | immediately after anesthesia induction | 
| CSF neuron specific enolase(NSE), |  | immediately after anesthesia induction | 
| CSF MBP |  | immediately after anesthesia induction | 
| CSF GFAP |  | immediately after anesthesia induction | 
| CSF Tumor Necrosis Factor-α(TNF-α) |  | immediately after anesthesia induction | 
| CSF interleukin-10 (IL-10) |  | immediately after anesthesia induction | 
| CSF IL-6 |  | immediately after anesthesia induction | 
| CSF IL-2 |  | immediately after anesthesia induction | 
| somatosensory evoked potential(SEP) |  | immediately after anesthesia induction | 
| MEP |  | immediately after anesthesia induction | 
| Mini mental state ex amination |  | the 7th day after the surgery | 
| NIHSS's score |  | the 2nd day after the surgery | 
| NIHSS's score |  | the 3rd day after the surgery | 
| ASIA's score |  | the 1st day after the surgery | 
| ASIA's score |  | the 2nd day after the surgery | 
| ASIA's score |  | the 3rd day after the surgery | 
| plasma S100β |  | immediately the end of surgery | 
| plasma S100β |  | the 1st day after the surgery | 
| plasma S100β |  | the 3rd day after the surgery | 
| plasma S100β |  | the 7th day after the surgery | 
| plasma neuron specific enolase, |  | immediately the end of surgery | 
| plasma neuron specific enolase, |  | the 1st day after the surgery | 
| plasma neuron specific enolase, |  | the 3rd day after the surgery | 
| plasma neuron specific enolase, |  | the 7th day after the surgery | 
| plasma MBP |  | immediately the end of surgery | 
| plasma MBP |  | the 1st day after the surgery | 
| plasma MBP |  | the 3rd day after the surgery | 
| plasma MBP |  | the 7th day after the surgery | 
| plasma GFAP |  | immediately the end of surgery | 
| plasma GFAP |  | the 1st day after the surgery | 
| plasma GFAP |  | the 3rd day after the surgery | 
| plasma GFAP |  | the 7th day after the surgery | 
| CSF S100β |  | immediately the end of surgery | 
| CSF S100β |  | the 1st day after the surgery | 
| CSF S100β |  | the 2nd day after the surgery | 
| CSF S100β |  | the 3rd day after the surgery | 
| CSF neuron specific enolase, |  | immediately the end of surgery | 
| CSF neuron specific enolase, |  | the 1st day after the surgery | 
| CSF neuron specific enolase, |  | the 2nd day after the surgery | 
| CSF neuron specific enolase, |  | the 3rd day after the surgery | 
| CSF MBP |  | immediately the end of surgery | 
| CSF MBP |  | the 1st day after the surgery | 
| CSF MBP |  | the 2nd day after the surgery | 
| CSF MBP |  | the 3rd day after the surgery | 
| CSF GFAP |  | immediately the end of surgery | 
| CSF GFAP |  | the 1st day after the surgery | 
| CSF GFAP |  | the 2nd day after the surgery | 
| CSF GFAP |  | the 3rd day after the surgery | 
| CSF TNF-α |  | immediately the end of surgery | 
| CSF TNF-α |  | the 1st day after the surgery | 
| CSF TNF-α |  | the 2nd day after the surgery | 
| CSF TNF-α |  | the 3rd day after the surgery | 
| CSF IL-10 |  | immediately the end of surgery | 
| CSF IL-10 |  | the 1st day after surgery | 
| CSF IL-10 |  | the 2nd day after surgery | 
| CSF IL-10 |  | the 3rd day after surgery | 
| CSF IL-6 |  | immediately the end of surgery | 
| CSF IL-6 |  | the 1st day after surgery | 
| CSF IL-6 |  | the 2nd day after surgery | 
| CSF IL-6 |  | the 3rd day after surgery | 
| CSF IL-2 |  | immediately the end of surgery | 
| CSF IL-2 |  | the 1st day after surgery | 
| CSF IL-2 |  | the 2nd day after surgery | 
| CSF IL-2 |  | the 3rd day after surgery | 
| SEP |  | immediately after blocking the aorta | 
| SEP |  | immediately after opening the aorta | 
| SEP |  | immediately the end of the surgery | 
| SEP |  | the 4th hour after back to ICU | 
| MEP |  | immediately after blocking the aorta | 
| MEP |  | immediately after opening the aorta | 
| MEP |  | immediately the end of the surgery | 
| MEP |  | the 4th hour after back to ICU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic dissection, Cerebral and Spinal Protection, Post-conditioning