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

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 Overview

• Status: Unknown
• Conditions: Aortic Dissection
• Intervention / Treatment: Drug: xenon

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: xenon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Investigators: Principal Investigator: WeiPing Cheng, master, Chief Physician，Professor

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: April 25, 2016
• First Submitted That Met QC Criteria: May 12, 2016
• First Posted (Estimate): May 17, 2016

Study Record Updates

• Last Update Posted (Estimate): May 17, 2016
• Last Update Submitted That Met QC Criteria: May 12, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Aortic dissection; Post-conditioning; Cerebral and Spinal Protection
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Anesthetics, Inhalation; Xenon
• Other Study ID Numbers: WCheng 2014-8-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED