Cerebral and Spinal Protection of Xenon Post-conditioning in Patients Undergoing Aortic Dissection Repair
2016년 5월 12일 업데이트: 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
연구 개요
연구 유형
중재적
등록 (예상)
120
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: Control group（Ascending aorta）
undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair
|
|
|
실험적: Xenon Post-conditioning
undergo ascending aorta Dissection Repair and thoracoabdominal aortic Dissection Repair
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
mini mental state examination
기간: 18h before the surgery
|
18h before the surgery
|
|
NIHSS's score
기간: the 1st day after the surgery
|
the 1st day after the surgery
|
|
ASIA impairment scale（ASIA's score ）
기간: 18h before the surgery
|
18h before the surgery
|
|
males
기간: 18h before the surgery
|
18h before the surgery
|
|
age
기간: 18h before the surgery
|
18h before the surgery
|
|
height
기간: 18h before the surgery
|
18h before the surgery
|
|
weight
기간: 18h before the surgery
|
18h before the surgery
|
|
History of Smoking
기간: 18h before the surgery
|
18h before the surgery
|
|
History of Hypertension
기간: 18h before the surgery
|
18h before the surgery
|
|
History of Diabetes Mellitus
기간: 18h before the surgery
|
18h before the surgery
|
|
New York Heart Association Heart function score
기간: 18h before the surgery
|
18h before the surgery
|
|
duration of cardiopulmonary bypass (CPB)
기간: 1h after the surgery
|
1h after the surgery
|
|
duration of Aortic cross-clamping
기간: 1h after the surgery
|
1h after the surgery
|
|
duration of low flow in CPB
기간: 1h after the surgery
|
1h after the surgery
|
|
duration of stopping the circulation
기간: 1h after the surgery
|
1h after the surgery
|
|
the lowest nasopharyngeal temperature
기간: 1h after the surgery
|
1h after the surgery
|
|
the lowest rectal temperature
기간: 1h after the surgery
|
1h after the surgery
|
|
duration of surgery
기간: 1h after the surgery
|
1h after the surgery
|
|
duration of recovering of consciousness from the end of the surgery
기간: 3 days after the surgery
|
3 days after the surgery
|
|
duration of extubation from the end of the surgery
기간: 3 days after the surgery
|
3 days after the surgery
|
|
duration in the ICU
기간: 15 days after the surgery
|
15 days after the surgery
|
|
days in hospital
기간: 15 days after leaving hospital
|
15 days after leaving hospital
|
|
pulmonary infection
기간: 15 days after the surgery
|
15 days after the surgery
|
|
plasma S100β
기간: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
plasma neuron specific enolase,
기간: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
plasma myelin basic protein(MBP)
기간: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
plasma glial fibrillary acidic protein (GFAP)
기간: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
Cerebrospinal fluid(CSF) S100β
기간: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF neuron specific enolase(NSE),
기간: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF MBP
기간: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF GFAP
기간: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF Tumor Necrosis Factor-α(TNF-α)
기간: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF interleukin-10 (IL-10)
기간: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF IL-6
기간: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
CSF IL-2
기간: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
somatosensory evoked potential(SEP)
기간: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
MEP
기간: immediately after anesthesia induction
|
immediately after anesthesia induction
|
|
Mini mental state ex amination
기간: the 7th day after the surgery
|
the 7th day after the surgery
|
|
NIHSS's score
기간: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
NIHSS's score
기간: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
ASIA's score
기간: the 1st day after the surgery
|
the 1st day after the surgery
|
|
ASIA's score
기간: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
ASIA's score
기간: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma S100β
기간: immediately the end of surgery
|
immediately the end of surgery
|
|
plasma S100β
기간: the 1st day after the surgery
|
the 1st day after the surgery
|
|
plasma S100β
기간: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma S100β
기간: the 7th day after the surgery
|
the 7th day after the surgery
|
|
plasma neuron specific enolase,
기간: immediately the end of surgery
|
immediately the end of surgery
|
|
plasma neuron specific enolase,
기간: the 1st day after the surgery
|
the 1st day after the surgery
|
|
plasma neuron specific enolase,
기간: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma neuron specific enolase,
기간: the 7th day after the surgery
|
the 7th day after the surgery
|
|
plasma MBP
기간: immediately the end of surgery
|
immediately the end of surgery
|
|
plasma MBP
기간: the 1st day after the surgery
|
the 1st day after the surgery
|
|
plasma MBP
기간: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma MBP
기간: the 7th day after the surgery
|
the 7th day after the surgery
|
|
plasma GFAP
기간: immediately the end of surgery
|
immediately the end of surgery
|
|
plasma GFAP
기간: the 1st day after the surgery
|
the 1st day after the surgery
|
|
plasma GFAP
기간: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
plasma GFAP
기간: the 7th day after the surgery
|
the 7th day after the surgery
|
|
CSF S100β
기간: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF S100β
기간: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF S100β
기간: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF S100β
기간: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF neuron specific enolase,
기간: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF neuron specific enolase,
기간: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF neuron specific enolase,
기간: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF neuron specific enolase,
기간: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF MBP
기간: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF MBP
기간: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF MBP
기간: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF MBP
기간: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF GFAP
기간: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF GFAP
기간: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF GFAP
기간: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF GFAP
기간: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF TNF-α
기간: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF TNF-α
기간: the 1st day after the surgery
|
the 1st day after the surgery
|
|
CSF TNF-α
기간: the 2nd day after the surgery
|
the 2nd day after the surgery
|
|
CSF TNF-α
기간: the 3rd day after the surgery
|
the 3rd day after the surgery
|
|
CSF IL-10
기간: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF IL-10
기간: the 1st day after surgery
|
the 1st day after surgery
|
|
CSF IL-10
기간: the 2nd day after surgery
|
the 2nd day after surgery
|
|
CSF IL-10
기간: the 3rd day after surgery
|
the 3rd day after surgery
|
|
CSF IL-6
기간: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF IL-6
기간: the 1st day after surgery
|
the 1st day after surgery
|
|
CSF IL-6
기간: the 2nd day after surgery
|
the 2nd day after surgery
|
|
CSF IL-6
기간: the 3rd day after surgery
|
the 3rd day after surgery
|
|
CSF IL-2
기간: immediately the end of surgery
|
immediately the end of surgery
|
|
CSF IL-2
기간: the 1st day after surgery
|
the 1st day after surgery
|
|
CSF IL-2
기간: the 2nd day after surgery
|
the 2nd day after surgery
|
|
CSF IL-2
기간: the 3rd day after surgery
|
the 3rd day after surgery
|
|
SEP
기간: immediately after blocking the aorta
|
immediately after blocking the aorta
|
|
SEP
기간: immediately after opening the aorta
|
immediately after opening the aorta
|
|
SEP
기간: immediately the end of the surgery
|
immediately the end of the surgery
|
|
SEP
기간: the 4th hour after back to ICU
|
the 4th hour after back to ICU
|
|
MEP
기간: immediately after blocking the aorta
|
immediately after blocking the aorta
|
|
MEP
기간: immediately after opening the aorta
|
immediately after opening the aorta
|
|
MEP
기간: immediately the end of the surgery
|
immediately the end of the surgery
|
|
MEP
기간: the 4th hour after back to ICU
|
the 4th hour after back to ICU
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: WeiPing Cheng, master, Chief Physician，Professor
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2016년 2월 1일
기본 완료 (예상)
2018년 7월 1일
연구 완료 (예상)
2018년 9월 1일
연구 등록 날짜
최초 제출
2016년 4월 25일
QC 기준을 충족하는 최초 제출
2016년 5월 12일
처음 게시됨 (추정)
2016년 5월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 5월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 5월 12일
마지막으로 확인됨
2016년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .