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

12 maggio 2016 aggiornato da: 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

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Anticipato)

120

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 60 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Control group（Ascending aorta）
undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair
Sperimentale: Xenon Post-conditioning
undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair
Droga: xenon

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
mini mental state examination
Lasso di tempo: 18h before the surgery
18h before the surgery
NIHSS's score
Lasso di tempo: the 1st day after the surgery
the 1st day after the surgery
ASIA impairment scale（ASIA's score ）
Lasso di tempo: 18h before the surgery
18h before the surgery
males
Lasso di tempo: 18h before the surgery
18h before the surgery
age
Lasso di tempo: 18h before the surgery
18h before the surgery
height
Lasso di tempo: 18h before the surgery
18h before the surgery
weight
Lasso di tempo: 18h before the surgery
18h before the surgery
History of Smoking
Lasso di tempo: 18h before the surgery
18h before the surgery
History of Hypertension
Lasso di tempo: 18h before the surgery
18h before the surgery
History of Diabetes Mellitus
Lasso di tempo: 18h before the surgery
18h before the surgery
New York Heart Association Heart function score
Lasso di tempo: 18h before the surgery
18h before the surgery
duration of cardiopulmonary bypass (CPB)
Lasso di tempo: 1h after the surgery
1h after the surgery
duration of Aortic cross-clamping
Lasso di tempo: 1h after the surgery
1h after the surgery
duration of low flow in CPB
Lasso di tempo: 1h after the surgery
1h after the surgery
duration of stopping the circulation
Lasso di tempo: 1h after the surgery
1h after the surgery
the lowest nasopharyngeal temperature
Lasso di tempo: 1h after the surgery
1h after the surgery
the lowest rectal temperature
Lasso di tempo: 1h after the surgery
1h after the surgery
duration of surgery
Lasso di tempo: 1h after the surgery
1h after the surgery
duration of recovering of consciousness from the end of the surgery
Lasso di tempo: 3 days after the surgery
3 days after the surgery
duration of extubation from the end of the surgery
Lasso di tempo: 3 days after the surgery
3 days after the surgery
duration in the ICU
Lasso di tempo: 15 days after the surgery
15 days after the surgery
days in hospital
Lasso di tempo: 15 days after leaving hospital
15 days after leaving hospital
pulmonary infection
Lasso di tempo: 15 days after the surgery
15 days after the surgery
plasma S100β
Lasso di tempo: immediately after anesthesia induction
immediately after anesthesia induction
plasma neuron specific enolase,
Lasso di tempo: immediately after anesthesia induction
immediately after anesthesia induction
plasma myelin basic protein(MBP)
Lasso di tempo: immediately after anesthesia induction
immediately after anesthesia induction
plasma glial fibrillary acidic protein (GFAP)
Lasso di tempo: immediately after anesthesia induction
immediately after anesthesia induction
Cerebrospinal fluid(CSF) S100β
Lasso di tempo: immediately after anesthesia induction
immediately after anesthesia induction
CSF neuron specific enolase(NSE),
Lasso di tempo: immediately after anesthesia induction
immediately after anesthesia induction
CSF MBP
Lasso di tempo: immediately after anesthesia induction
immediately after anesthesia induction
CSF GFAP
Lasso di tempo: immediately after anesthesia induction
immediately after anesthesia induction
CSF Tumor Necrosis Factor-α(TNF-α)
Lasso di tempo: immediately after anesthesia induction
immediately after anesthesia induction
CSF interleukin-10 (IL-10)
Lasso di tempo: immediately after anesthesia induction
immediately after anesthesia induction
CSF IL-6
Lasso di tempo: immediately after anesthesia induction
immediately after anesthesia induction
CSF IL-2
Lasso di tempo: immediately after anesthesia induction
immediately after anesthesia induction
somatosensory evoked potential(SEP)
Lasso di tempo: immediately after anesthesia induction
immediately after anesthesia induction
MEP
Lasso di tempo: immediately after anesthesia induction
immediately after anesthesia induction
Mini mental state ex amination
Lasso di tempo: the 7th day after the surgery
the 7th day after the surgery
NIHSS's score
Lasso di tempo: the 2nd day after the surgery
the 2nd day after the surgery
NIHSS's score
Lasso di tempo: the 3rd day after the surgery
the 3rd day after the surgery
ASIA's score
Lasso di tempo: the 1st day after the surgery
the 1st day after the surgery
ASIA's score
Lasso di tempo: the 2nd day after the surgery
the 2nd day after the surgery
ASIA's score
Lasso di tempo: the 3rd day after the surgery
the 3rd day after the surgery
plasma S100β
Lasso di tempo: immediately the end of surgery
immediately the end of surgery
plasma S100β
Lasso di tempo: the 1st day after the surgery
the 1st day after the surgery
plasma S100β
Lasso di tempo: the 3rd day after the surgery
the 3rd day after the surgery
plasma S100β
Lasso di tempo: the 7th day after the surgery
the 7th day after the surgery
plasma neuron specific enolase,
Lasso di tempo: immediately the end of surgery
immediately the end of surgery
plasma neuron specific enolase,
Lasso di tempo: the 1st day after the surgery
the 1st day after the surgery
plasma neuron specific enolase,
Lasso di tempo: the 3rd day after the surgery
the 3rd day after the surgery
plasma neuron specific enolase,
Lasso di tempo: the 7th day after the surgery
the 7th day after the surgery
plasma MBP
Lasso di tempo: immediately the end of surgery
immediately the end of surgery
plasma MBP
Lasso di tempo: the 1st day after the surgery
the 1st day after the surgery
plasma MBP
Lasso di tempo: the 3rd day after the surgery
the 3rd day after the surgery
plasma MBP
Lasso di tempo: the 7th day after the surgery
the 7th day after the surgery
plasma GFAP
Lasso di tempo: immediately the end of surgery
immediately the end of surgery
plasma GFAP
Lasso di tempo: the 1st day after the surgery
the 1st day after the surgery
plasma GFAP
Lasso di tempo: the 3rd day after the surgery
the 3rd day after the surgery
plasma GFAP
Lasso di tempo: the 7th day after the surgery
the 7th day after the surgery
CSF S100β
Lasso di tempo: immediately the end of surgery
immediately the end of surgery
CSF S100β
Lasso di tempo: the 1st day after the surgery
the 1st day after the surgery
CSF S100β
Lasso di tempo: the 2nd day after the surgery
the 2nd day after the surgery
CSF S100β
Lasso di tempo: the 3rd day after the surgery
the 3rd day after the surgery
CSF neuron specific enolase,
Lasso di tempo: immediately the end of surgery
immediately the end of surgery
CSF neuron specific enolase,
Lasso di tempo: the 1st day after the surgery
the 1st day after the surgery
CSF neuron specific enolase,
Lasso di tempo: the 2nd day after the surgery
the 2nd day after the surgery
CSF neuron specific enolase,
Lasso di tempo: the 3rd day after the surgery
the 3rd day after the surgery
CSF MBP
Lasso di tempo: immediately the end of surgery
immediately the end of surgery
CSF MBP
Lasso di tempo: the 1st day after the surgery
the 1st day after the surgery
CSF MBP
Lasso di tempo: the 2nd day after the surgery
the 2nd day after the surgery
CSF MBP
Lasso di tempo: the 3rd day after the surgery
the 3rd day after the surgery
CSF GFAP
Lasso di tempo: immediately the end of surgery
immediately the end of surgery
CSF GFAP
Lasso di tempo: the 1st day after the surgery
the 1st day after the surgery
CSF GFAP
Lasso di tempo: the 2nd day after the surgery
the 2nd day after the surgery
CSF GFAP
Lasso di tempo: the 3rd day after the surgery
the 3rd day after the surgery
CSF TNF-α
Lasso di tempo: immediately the end of surgery
immediately the end of surgery
CSF TNF-α
Lasso di tempo: the 1st day after the surgery
the 1st day after the surgery
CSF TNF-α
Lasso di tempo: the 2nd day after the surgery
the 2nd day after the surgery
CSF TNF-α
Lasso di tempo: the 3rd day after the surgery
the 3rd day after the surgery
CSF IL-10
Lasso di tempo: immediately the end of surgery
immediately the end of surgery
CSF IL-10
Lasso di tempo: the 1st day after surgery
the 1st day after surgery
CSF IL-10
Lasso di tempo: the 2nd day after surgery
the 2nd day after surgery
CSF IL-10
Lasso di tempo: the 3rd day after surgery
the 3rd day after surgery
CSF IL-6
Lasso di tempo: immediately the end of surgery
immediately the end of surgery
CSF IL-6
Lasso di tempo: the 1st day after surgery
the 1st day after surgery
CSF IL-6
Lasso di tempo: the 2nd day after surgery
the 2nd day after surgery
CSF IL-6
Lasso di tempo: the 3rd day after surgery
the 3rd day after surgery
CSF IL-2
Lasso di tempo: immediately the end of surgery
immediately the end of surgery
CSF IL-2
Lasso di tempo: the 1st day after surgery
the 1st day after surgery
CSF IL-2
Lasso di tempo: the 2nd day after surgery
the 2nd day after surgery
CSF IL-2
Lasso di tempo: the 3rd day after surgery
the 3rd day after surgery
SEP
Lasso di tempo: immediately after blocking the aorta
immediately after blocking the aorta
SEP
Lasso di tempo: immediately after opening the aorta
immediately after opening the aorta
SEP
Lasso di tempo: immediately the end of the surgery
immediately the end of the surgery
SEP
Lasso di tempo: the 4th hour after back to ICU
the 4th hour after back to ICU
MEP
Lasso di tempo: immediately after blocking the aorta
immediately after blocking the aorta
MEP
Lasso di tempo: immediately after opening the aorta
immediately after opening the aorta
MEP
Lasso di tempo: immediately the end of the surgery
immediately the end of the surgery
MEP
Lasso di tempo: the 4th hour after back to ICU
the 4th hour after back to ICU

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Beijing Anzhen Hospital

Investigatori

  • Investigatore principale: WeiPing Cheng, master, Chief Physician，Professor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2016

Completamento primario (Anticipato)

1 luglio 2018

Completamento dello studio (Anticipato)

1 settembre 2018

Date di iscrizione allo studio

Primo inviato

25 aprile 2016

Primo inviato che soddisfa i criteri di controllo qualità

12 maggio 2016

Primo Inserito (Stima)

17 maggio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

17 maggio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 maggio 2016

Ultimo verificato

1 maggio 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • WCheng 2014-8-24

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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