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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02774096
Enrollment
120
Registered
2016-05-17
Start date
2016-02-29
Completion date
2018-09-30
Last updated
2016-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Dissection

Keywords

Aortic dissection, Cerebral and Spinal Protection, Post-conditioning

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

Interventions

DRUGxenon

Sponsors

Beijing Anzhen Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
plasma myelin basic protein(MBP)immediately after anesthesia induction
plasma glial fibrillary acidic protein (GFAP)immediately after anesthesia induction
Cerebrospinal fluid(CSF) S100βimmediately after anesthesia induction
CSF neuron specific enolase(NSE),immediately after anesthesia induction
CSF MBPimmediately after anesthesia induction
mini mental state examination18h before the surgery
NIHSS's scorethe 1st day after the surgery
ASIA impairment scale(ASIA's score )18h before the surgery
males18h before the surgery
age18h before the surgery
height18h before the surgery
weight18h before the surgery
History of Smoking18h before the surgery
History of Hypertension18h before the surgery
History of Diabetes Mellitus18h before the surgery
New York Heart Association Heart function score18h before the surgery
duration of cardiopulmonary bypass (CPB)1h after the surgery
duration of Aortic cross-clamping1h after the surgery
duration of low flow in CPB1h after the surgery
duration of stopping the circulation1h after the surgery
the lowest nasopharyngeal temperature1h after the surgery
the lowest rectal temperature1h after the surgery
duration of surgery1h after the surgery
duration of recovering of consciousness from the end of the surgery3 days after the surgery
duration of extubation from the end of the surgery3 days after the surgery
duration in the ICU15 days after the surgery
days in hospital15 days after leaving hospital
pulmonary infection15 days after the surgery
plasma S100βimmediately after anesthesia induction
plasma neuron specific enolase,immediately after anesthesia induction
CSF GFAPimmediately 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-6immediately after anesthesia induction
CSF IL-2immediately after anesthesia induction
somatosensory evoked potential(SEP)immediately after anesthesia induction
MEPimmediately after anesthesia induction
Mini mental state ex aminationthe 7th day after the surgery
ASIA's scorethe 1st day after the surgery
plasma MBPimmediately the end of surgery
plasma GFAPimmediately the end of surgery
CSF S100βimmediately the end of surgery
CSF neuron specific enolase,immediately the end of surgery
CSF TNF-αimmediately the end of surgery
CSF IL-10immediately the end of surgery
SEPimmediately after blocking the aorta

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026