Cerebral and Spinal Protection of Xenon Post-conditioning in Patients Undergoing Aortic Dissection Repair
12 maja 2016 zaktualizowane przez: WeiPing Cheng, Beijing Anzhen Hospital
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
Przegląd badań
Typ studiów
Interwencyjne
Zapisy (Oczekiwany)
120
Faza
- Nie dotyczy
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 60 lat (Dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Brak interwencji: Control group（Ascending aorta）
undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair
|
|
|
Eksperymentalny: Xenon Post-conditioning
undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
mini mental state examination
Ramy czasowe: 18h before the surgery
|
18h before the surgery
|
|
NIHSS's score
Ramy czasowe: the 1st day after the surgery
|
the 1st day after the surgery
|
|
ASIA impairment scale（ASIA's score ）
Ramy czasowe: 18h before the surgery
|
18h before the surgery
|
|
males
Ramy czasowe: 18h before the surgery
|
18h before the surgery
|
|
age
Ramy czasowe: 18h before the surgery
|
18h before the surgery
|
|
height
Ramy czasowe: 18h before the surgery
|
18h before the surgery
|
|
weight
Ramy czasowe: 18h before the surgery
|
18h before the surgery
|
|
History of Smoking
Ramy czasowe: 18h before the surgery
|
18h before the surgery
|
|
History of Hypertension
Ramy czasowe: 18h before the surgery
|
18h before the surgery
|
|
History of Diabetes Mellitus
Ramy czasowe: 18h before the surgery
|
18h before the surgery
|
|
New York Heart Association Heart function score
Ramy czasowe: 18h before the surgery
|
18h before the surgery
|
|
duration of cardiopulmonary bypass (CPB)
Ramy czasowe: 1h after the surgery
|
1h after the surgery
|
|
duration of Aortic cross-clamping
Ramy czasowe: 1h after the surgery
|
1h after the surgery
|
|
duration of low flow in CPB
Ramy czasowe: 1h after the surgery
|
1h after the surgery
|
|
duration of stopping the circulation
Ramy czasowe: 1h after the surgery
|
1h after the surgery
|
|
the lowest nasopharyngeal temperature
Ramy czasowe: 1h after the surgery
|
1h after the surgery
|
|
the lowest rectal temperature
Ramy czasowe: 1h after the surgery
|
1h after the surgery
|
|
duration of surgery
Ramy czasowe: 1h after the surgery
|
1h after the surgery
|
|
duration of recovering of consciousness from the end of the surgery
Ramy czasowe: 3 days after the surgery
|
3 days after the surgery
|
|
duration of extubation from the end of the surgery
Ramy czasowe: 3 days after the surgery
|
3 days after the surgery
|
|
duration in the ICU
Ramy czasowe: 15 days after the surgery
|
15 days after the surgery
|
|
days in hospital
Ramy czasowe: 15 days after leaving hospital
|
15 days after leaving hospital
|
|
pulmonary infection
Ramy czasowe: 15 days after the surgery
|
15 days after the surgery
|
|
plasma S100β
Ramy czasowe: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
plasma neuron specific enolase,
Ramy czasowe: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
plasma myelin basic protein(MBP)
Ramy czasowe: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
plasma glial fibrillary acidic protein (GFAP)
Ramy czasowe: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
Cerebrospinal fluid(CSF) S100β
Ramy czasowe: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF neuron specific enolase(NSE),
Ramy czasowe: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF MBP
Ramy czasowe: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF GFAP
Ramy czasowe: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF Tumor Necrosis Factor-α(TNF-α)
Ramy czasowe: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF interleukin-10 (IL-10)
Ramy czasowe: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF IL-6
Ramy czasowe: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF IL-2
Ramy czasowe: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
somatosensory evoked potential(SEP)
Ramy czasowe: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
MEP
Ramy czasowe: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
Mini mental state ex amination
Ramy czasowe: the 7th day after the surgery
|
the 7th day after the surgery
|
|
NIHSS's score
Ramy czasowe: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
NIHSS's score
Ramy czasowe: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
ASIA's score
Ramy czasowe: the 1st day after the surgery
|
the 1st day after the surgery
|
|
ASIA's score
Ramy czasowe: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
ASIA's score
Ramy czasowe: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma S100β
Ramy czasowe: immediately the end of surgery
|
immediately the end of surgery
|
|
plasma S100β
Ramy czasowe: the 1st day after the surgery
|
the 1st day after the surgery
|
|
plasma S100β
Ramy czasowe: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma S100β
Ramy czasowe: the 7th day after the surgery
|
the 7th day after the surgery
|
|
plasma neuron specific enolase,
Ramy czasowe: immediately the end of surgery
|
immediately the end of surgery
|
|
plasma neuron specific enolase,
Ramy czasowe: the 1st day after the surgery
|
the 1st day after the surgery
|
|
plasma neuron specific enolase,
Ramy czasowe: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma neuron specific enolase,
Ramy czasowe: the 7th day after the surgery
|
the 7th day after the surgery
|
|
plasma MBP
Ramy czasowe: immediately the end of surgery
|
immediately the end of surgery
|
|
plasma MBP
Ramy czasowe: the 1st day after the surgery
|
the 1st day after the surgery
|
|
plasma MBP
Ramy czasowe: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma MBP
Ramy czasowe: the 7th day after the surgery
|
the 7th day after the surgery
|
|
plasma GFAP
Ramy czasowe: immediately the end of surgery
|
immediately the end of surgery
|
|
plasma GFAP
Ramy czasowe: the 1st day after the surgery
|
the 1st day after the surgery
|
|
plasma GFAP
Ramy czasowe: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma GFAP
Ramy czasowe: the 7th day after the surgery
|
the 7th day after the surgery
|
|
CSF S100β
Ramy czasowe: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF S100β
Ramy czasowe: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF S100β
Ramy czasowe: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF S100β
Ramy czasowe: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF neuron specific enolase,
Ramy czasowe: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF neuron specific enolase,
Ramy czasowe: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF neuron specific enolase,
Ramy czasowe: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF neuron specific enolase,
Ramy czasowe: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF MBP
Ramy czasowe: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF MBP
Ramy czasowe: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF MBP
Ramy czasowe: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF MBP
Ramy czasowe: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF GFAP
Ramy czasowe: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF GFAP
Ramy czasowe: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF GFAP
Ramy czasowe: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF GFAP
Ramy czasowe: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF TNF-α
Ramy czasowe: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF TNF-α
Ramy czasowe: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF TNF-α
Ramy czasowe: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF TNF-α
Ramy czasowe: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF IL-10
Ramy czasowe: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF IL-10
Ramy czasowe: the 1st day after surgery
|
the 1st day after surgery
|
|
CSF IL-10
Ramy czasowe: the 2nd day after surgery
|
the 2nd day after surgery
|
|
CSF IL-10
Ramy czasowe: the 3rd day after surgery
|
the 3rd day after surgery
|
|
CSF IL-6
Ramy czasowe: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF IL-6
Ramy czasowe: the 1st day after surgery
|
the 1st day after surgery
|
|
CSF IL-6
Ramy czasowe: the 2nd day after surgery
|
the 2nd day after surgery
|
|
CSF IL-6
Ramy czasowe: the 3rd day after surgery
|
the 3rd day after surgery
|
|
CSF IL-2
Ramy czasowe: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF IL-2
Ramy czasowe: the 1st day after surgery
|
the 1st day after surgery
|
|
CSF IL-2
Ramy czasowe: the 2nd day after surgery
|
the 2nd day after surgery
|
|
CSF IL-2
Ramy czasowe: the 3rd day after surgery
|
the 3rd day after surgery
|
|
SEP
Ramy czasowe: immediately after blocking the aorta
|
immediately after blocking the aorta
|
|
SEP
Ramy czasowe: immediately after opening the aorta
|
immediately after opening the aorta
|
|
SEP
Ramy czasowe: immediately the end of the surgery
|
immediately the end of the surgery
|
|
SEP
Ramy czasowe: the 4th hour after back to ICU
|
the 4th hour after back to ICU
|
|
MEP
Ramy czasowe: immediately after blocking the aorta
|
immediately after blocking the aorta
|
|
MEP
Ramy czasowe: immediately after opening the aorta
|
immediately after opening the aorta
|
|
MEP
Ramy czasowe: immediately the end of the surgery
|
immediately the end of the surgery
|
|
MEP
Ramy czasowe: the 4th hour after back to ICU
|
the 4th hour after back to ICU
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: WeiPing Cheng, master, Chief Physician，Professor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 lutego 2016
Zakończenie podstawowe (Oczekiwany)
1 lipca 2018
Ukończenie studiów (Oczekiwany)
1 września 2018
Daty rejestracji na studia
Pierwszy przesłany
25 kwietnia 2016
Pierwszy przesłany, który spełnia kryteria kontroli jakości
12 maja 2016
Pierwszy wysłany (Oszacować)
17 maja 2016
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
17 maja 2016
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
12 maja 2016
Ostatnia weryfikacja
1 maja 2016
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- WCheng 2014-8-24
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .