Propofol vs Sevoflurane in Cardiac Surgery: a Randomized Clinical Trial During the Peroperative and Postoperative Phase
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- determine the relationship between myocardial protection and type of anesthesia
研究概览
简要总结
The hypothesis of our study: presence of a relationship between the type of anesthesia and complications after cardiac surgery. The aim is to assess the benefit of using intravenous or inhaled anesthesia on the patients' stay and its complications.
详细描述
Cardiac surgery presents unique challenges for anesthesiologists as they are responsible for amnesia, analgesia, muscle relaxation, and maintenance of organ functions in the context of CPB-induced pathophysiological changes. Postoperative complications are vast and varied, leading to a prolonged stay in cardiac intensive care. However, the question of the superiority of one anesthesia protocol over another in cardiac surgery is debated.
The AHA (American Heart Association) recommended the use of inhalation anesthesia to reduce the risk of perioperative myocardial ischemia and infarction in 2011. However, in 2019, this recommendation lost a step in its level of proof and therefore the debate is still open.
Indeed, a "MYRIAD" study carried out on five continents determined that the administration of a halogenated volatile agent provided clinical benefit to patients undergoing coronary revascularization surgery. The study was randomized, single-blind, multicenter, carried out on patients scheduled for coronary bypass surgery with or without extracorporeal circulation (ECB).
Volatile halogenated agents (AVH) have cardioprotective properties via a pre- and post-conditioning phenomenon. Several meta-analyses have shown a benefit from the use of AVH during coronary surgery and in particular a reduction in mortality.
Note that the choice of type of anesthesia is made according to the habits of the department and the anesthetist and is in no way linked to the patient's condition or the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients above 18 yeras old that will undergo a cardiac surgery
排除标准
- •below 18 yeras old
研究组 & 干预措施
sedation using propofol
this group will include all patients who will receive propofol during the cardiac surgery and afterwards in the intensive care unit during the post operative phase
干预措施: sedation using propofol (Drug)
sedation using sevoflurane
this group will include all patients who will receive sevoflurance druing the cardiac surgery and afterwards in the intensive care unit during the postoperative phase
干预措施: sedation using sevoflurane (Drug)
结局指标
主要结局
determine the relationship between myocardial protection and type of anesthesia
时间窗: 48 hours after the surgery
troponin T dosage
次要结局
- Association between the type of anesthesia and the speed of awakening(48 hours after the surgery)
- Association between the length of stay in intensive care and the type of anesthesia(72 hours after the surgery)
- Determine a relationship between the type of anesthesia and the hemodynamic profile(48 hours after the surgery)
- Association between the type of anesthesia and pulmonary complications(72 hours after the surgery)
- Association between the type of anesthesia and neurological complications(72 hours after the surgery)