- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01704092
Dexmedetomidine's Cardiac and Cognitive Influence on Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
The emergence of off-pump coronary artery bypass grafting (OPCAB) procedure brings up new challenges to anesthesiologists and urges us to contemplate the choice of anesthetics. In face of these challenges Dexmedetomdine with multiple unique traits can readily fit into this situation.
Off-pump coronary artery bypass (OPCAB) procedure is an emerging procedure which might bring benefit to patients in comparison with conventional CABGs although final words about outcomes haven't been reached on the basis of recent literature. However, OPCAB technique definitely requires more involvement of anesthesiologists especially in cases where hemodynamic compromise is usually inevitable during anastomosis of Lcx or PDA and early extubation in the OR is expected1. Thus, the investigators are encountered with more intraoperative challenges caused by OPCAB than routine CABGs. Concerning about challenges the investigators might take on, the investigators shall not only pay more attention to surgeons' manipulation but also review anesthetics that the investigators have selected to find an optimal plan to minimize adverse effects on heart and other important organs. With this perspective, dexmedetomidine come into our sight with its peculiar traits of hemodynamic effects and assumed cardiac protective effects.
Dexmedetomidine as a more selective α2-adrenoreceptor agonist than clonidine has gradually gain popularity in anesthetic and ICU settings for its unique pharmacologic characteristics. Dexmedetomidine provides sufficient sedative effects with minimal respiratory effect and then reduces the consumption of other sedative and antinociceptive drugs.Given specific requirements of OPCAB surgery, dexmedetomidine's may be more suitable in varying aspects. Firstly, dexmedetomine can dramatically diminish the level of serum catecholamine (CA). As the investigators know, the diminished level of catecholamine indicates less stress response to surgical stimuli and lower incidence of cardiac events. Secondly, the relatively slower HR by dexmedetomidine can decrease oxygen consumption of myocardium and consequently improve the perfusion of endangered ischemic area. In addition, the decreased HR which is assumably analogous to effects of esmolol or other β-blockers can reduce the occurrence of tachycardia and minimize the motion of heart when "bypass" procedure is performed on the target vessels. Thirdly, it has been reported that dexmedetomidine can alleviate sufferings of renal function during major thoracic surgery .Thus, it is implied that dexmedetomidine might in the similar way ameliorate the damage to renal system caused by hours of stress response and havoc of SIRS ,and then improve clinical prognosis . In view of assumptions the investigators have proposed on the ground of dexmedetomidine's characteristics and specific requirements of OPCAB surgery, the investigators are expecting that dexmdetomidine can fit the situation where patients' limited capacity of coronary artery and sophisticated pathophysiological courses have to be taken into account.
Тип исследования
Регистрация (Ожидаемый)
Контакты и местонахождение
Места учебы
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Hubei
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Wuhan, Hubei, Китай, 430030
- Рекрутинг
- Department of Anesthesiology ,Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
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Главный следователь:
- Xin Chen, MD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) scores are between classⅡand Ⅲ
- undergo off-pump coronary artery bypass grafting (OPCAB)
Exclusion Criteria:
- left ventricular ejection fraction <40%
- left ventricular aneurysm
- acute myocardial infarction in latest two weeks
- atrial fibrillation
- associated vascular diseases
- severe systemic diseases involving the renal and hepatic systems
- respiratory disease( forced vital capacity less than 50% of predicted values ) preoperative left bundle branch block .
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
Group High-dose
Dexmedetomidine loading dose 1μg/kg Dexmedetomidine maintenance dose 0.6μg/kg/h
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Group Low-dose
Dexmedetomidine loading dose 0.6μg/kg Dexmedetomidine maintenance dose 0.3μg/kg/h
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|
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Group Control
Dexmedetomidine loading dose and Dexmedetomidine maintenance dose were placed with the same amount of 0.9% saline as placebo
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
cardioprective results represented by serial determination of troponin I (cTnI) cardioprective results represented by serial determination of troponin I (cTnI)
Временное ограничение: up to 3 days after the surgery
|
The parameter measured is dynamic so that it is needed to detect the level at different time points
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up to 3 days after the surgery
|
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Hemodynamic values
Временное ограничение: from baseline to the end of the surgery
|
On the basis of our experience, the period from baseline to the end of the surgery is five hours on average and would depend on the complexity of the surgical procedure
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from baseline to the end of the surgery
|
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Serum level of β-amyloid protein
Временное ограничение: up to 3 days after the surgery
|
The study is going to reflect the degree of central nerve system damage by detecting the level of S100 protein in serum.
The serum level of S100 is preferred rather than the CSF sample because the approach of CSF sample obtaining is invasive and costly.
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up to 3 days after the surgery
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Serum level of S100 protein
Временное ограничение: up to 3 days after the surgical procedure
|
The study is going to reflect the degree of central nerve system damage by detecting the level of S100 protein in serum.
The serum level of S100 is preferred rather than the CSF sample because the approach of CSF sample obtaining is invasive and costly.
|
up to 3 days after the surgical procedure
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
intraoperative and postoperative urine output (UO), extubation time (ET), length of stay in ICU(LOSICU ) and length of hospital stay (LOS)
Временное ограничение: participants will be followed for the duration of hospital stay, an expected average of4 weeks
|
The intraoperative and postoperative urine output (UO), extubation time (ET), length of stay in ICU(LOSICU ) are measured in ICU while the length of hospital stay is recorded at the discharge of every patient.
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participants will be followed for the duration of hospital stay, an expected average of4 weeks
|
|
Mini-mental state examination(MMSE) scoring
Временное ограничение: up to patients' discharge from hospital
|
The study is planned to detect the cognitive performance with this commonly used cognitive evaluation scoring
|
up to patients' discharge from hospital
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Ишемия миокарда
- Сердечные заболевания
- Сердечно-сосудистые заболевания
- Сосудистые заболевания
- Артериосклероз
- Артериальные окклюзионные заболевания
- Коронарная болезнь
- Ишемическая болезнь сердца
- Физиологические эффекты лекарств
- Адренергические агенты
- Нейротрансмиттерные агенты
- Молекулярные механизмы фармакологического действия
- Депрессанты центральной нервной системы
- Агенты периферической нервной системы
- Анальгетики
- Агенты сенсорной системы
- Анальгетики, ненаркотические
- Агонисты адренергических альфа-2 рецепторов
- Адренергические альфа-агонисты
- Адренергические агонисты
- Снотворные и седативные средства
- Дексмедетомидин
Другие идентификационные номера исследования
- 2012001
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