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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2018

Interventions

  • Drug: xenon

Arms, Groups and Cohorts

  • No Intervention: Control group(Ascending aorta)
    • undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair
  • Experimental: Xenon Post-conditioning
    • undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Beijing Anzhen Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: WeiPing Cheng, Professor;Chief Physician – Beijing Anzhen Hospital
  • Overall Official(s)
    • WeiPing Cheng, master, Principal Investigator, Chief Physician,Professor

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