Clinical trial NCT02774096: Cerebral and Spinal Protection of Xenon Post-conditioning in Patients Undergoing Aortic Dissection Repair
Official title: Cerebral and Spinal Protection of Xenon Post-conditioning in Patients Undergoing Aortic Dissection Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Dissection
Keywords: Aortic dissection
Cerebral and Spinal Protection
Post-conditioning
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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


Eligibility criteria: 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

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