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

NCT02774096 | Unknown DMC

• 1 other identifier: WCheng 2014-8-24
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Conditions

Aortic Dissection

Keywords

Aortic dissection; Cerebral and Spinal Protection; Post-conditioning

Outcome Measures

Primary Outcomes (99)

• 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

Study Arms (2)

Control group（Ascending aorta）

NO INTERVENTION

undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair

Xenon Post-conditioning

EXPERIMENTAL

undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair

Drug: xenon

Interventions

xenon DRUG

Xenon Post-conditioning

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

MeSH Terms

Conditions

Aortic Dissection

Interventions

Xenon

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Intervention Hierarchy (Ancestors)

Noble Gases; Elements; Inorganic Chemicals; Gases

Study Officials

• WeiPing Cheng, master

  Chief Physician，Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor；Chief Physician

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: May 17, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: May 17, 2016

Record last verified: 2016-05