Randomized Isoflurane and Sevoflurane Comparison in Cardiac Surgery: A Prospective Randomized Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 464
- 试验地点
- 1
- 主要终点
- Composite of: prolonged ICU stay (>= 48 hours) OR death within 30 days of operation
研究概览
简要总结
Anesthesia practice in the 21st century is increasingly outcomes-oriented and evidence-based, but there remain significant gaps in our knowledge, even for commonly-encountered clinical situations. Currently, the two most commonly used drugs used for maintenance of anesthesia in cardiac surgical patients are isoflurane and sevoflurane. There is a belief among many cardiac anesthesiologists that sevoflurane is a better cardiac anesthetic than isoflurane, but there is very little data to support this notion. In fact, very little is known about their comparative effects on important patient outcomes because there has not been a large head-to-head prospective randomized clinical trial. This project will supply the data necessary to critically compare the two anesthetics.
详细描述
Current evidence supports the superiority of sevoflurane for myocardial protection during cardiac surgery when compared to total intravenous anesthesia with propofol. However, there is no evidence to suggest that sevoflurane is superior to isoflurane for myocardial protection during cardiac surgery. Sevoflurane may potentially reduce the rate of post-cardiac surgery atrial fibrillation and the time to tracheal extubation compared to isoflurane, but the literature is equivocal on these two important outcomes. Anesthesiologists still frequently use isoflurane for maintenance of cardiac anesthesia, and this is likely because there is substantial uncertainty about whether or not sevoflurane is superior to isoflurane, given the lack of head-to-head RCTs. A large, prospective, pragmatic RCT can ultimately assist clinicians by providing evidence of the non-inferiority (or, possibly the superiority) of one anesthetic compared to the other on important patient outcomes such as ICU length of stay, mortality, renal dysfunction, time to tracheal extubation after cardiac surgery, rates of clinically-important atrial fibrillation, and myocardial damage.
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 (Outcomes Assessor)
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
- •Patients must be 18 years or over (There is no upper age limit to enrollment)
- •Eligible procedures are: CABG on-pump or off-pump, single valve repair/replacement, or CABG/single valve combined procedures
排除标准
- •Cardiac surgeries that are not one of the included cases
- •Planned extubation in the operating room
- •Patients refusing blood products (vis à vis blood sampling)
- •Pregnant patients
- •Malignant hyperthermia or documented/stated allergy to potent volatile anesthetic agents
研究组 & 干预措施
sevoflurane
These patients will receive sevoflurane as the volatile anesthetic pre-, during-, and post-cardiopulmonary bypass at a targeted dose of 0.5-2.0 MAC.
干预措施: Volatile anesthetic (Drug)
isoflurane
These patients will receive isoflurane as the volatile anesthetic pre-, during-, and post-cardiopulmonary bypass at a targeted dose of 0.5-2.0 MAC.
干预措施: Volatile anesthetic (Drug)
结局指标
主要结局
Composite of: prolonged ICU stay (>= 48 hours) OR death within 30 days of operation
时间窗: 30 days of operation
次要结局
- Postoperative cardiac troponin T(6 hours after admission to ICU)
- Length of stay in the ICU (criteria)(Participants will be followed for the duration of ICU stay, an expected average of 1 day)
- 30-day all-cause mortality(30 days after operation)
- Peak postoperative serum creatinine(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- 1-year all-cause mortality(One year after operation)
- Prolonged inotrope or vasopressor usage in the ICU(Participants will be followed for the duration of ICU stay, an expected average of 1 day)
- New-onset dialysis(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Incidence of intra-aortic balloon pump usage(Participants will be followed for the duration of ICU stay, an expected average of 1 day)
- Length of stay in the ICU (actual)(Participants will be followed for the duration of ICU stay, an expected average of 1 day)
- Perioperative stroke(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Inotrope or vasopressor usage in the ICU(Participants will be followed for the duration of ICU stay, an expected average of 1 day)
- Incidence of new-onset atrial fibrillation(Until end of post-operative day 4)
- Duration of tracheal intubation(Participants will be followed for the duration of ICU stay, an expected average of 1 day)
- Readmission to ICU(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Length of stay in the hospital (actual)(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
研究者
Philip Jones
Principal Investigator
Lawson Health Research Institute