Overview

This trial is active, not recruiting.

Condition aortic dissection
Treatment xenon
Sponsor Beijing Anzhen Hospital
Start date February 2016
End date July 2018
Trial size 120 participants
Trial identifier NCT02774096, WCheng 2014-8-24

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(No Intervention)
undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair
(Experimental)
undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair
xenon

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Cerebral and Spinal Protection of Xenon Post-conditioning in Patients Undergoing Aortic Dissection Repair
Principal investigator WeiPing Cheng, master
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Beijing Anzhen Hospital.