- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01704092
Dexmedetomidine's Cardiac and Cognitive Influence on Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
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Hubei
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Wuhan, Hubei, Čína, 430030
- Nábor
- Department of Anesthesiology ,Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
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Vrchní vyšetřovatel:
- Xin Chen, MD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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 .
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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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Group Control
Dexmedetomidine loading dose and Dexmedetomidine maintenance dose were placed with the same amount of 0.9% saline as placebo
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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cardioprective results represented by serial determination of troponin I (cTnI) cardioprective results represented by serial determination of troponin I (cTnI)
Časové okno: up to 3 days after the surgery
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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
Časové okno: from baseline to the end of the surgery
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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
Časové okno: up to 3 days after the surgery
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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
Časové okno: up to 3 days after the surgical procedure
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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 surgical procedure
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
intraoperative and postoperative urine output (UO), extubation time (ET), length of stay in ICU(LOSICU ) and length of hospital stay (LOS)
Časové okno: participants will be followed for the duration of hospital stay, an expected average of4 weeks
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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
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Mini-mental state examination(MMSE) scoring
Časové okno: up to patients' discharge from hospital
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The study is planned to detect the cognitive performance with this commonly used cognitive evaluation scoring
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up to patients' discharge from hospital
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Ischémie myokardu
- Srdeční choroba
- Kardiovaskulární choroby
- Cévní onemocnění
- Arterioskleróza
- Arteriální okluzivní onemocnění
- Koronární onemocnění
- Ischemická choroba srdeční
- Fyziologické účinky léků
- Adrenergní látky
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Depresiva centrálního nervového systému
- Agenti periferního nervového systému
- Analgetika
- Agenti smyslového systému
- Analgetika, nenarkotika
- Agonisté adrenergních alfa-2 receptorů
- Adrenergní alfa-agonisté
- Adrenergní agonisté
- Hypnotika a sedativa
- Dexmedetomidin
Další identifikační čísla studie
- 2012001
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