REmimazolam vs Propofol Total Intravenous Anesthesia on Outcomes After Major Noncardiac SurgEry (REPOSE-2): A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 7,188
- 试验地点
- 44
- 主要终点
- Days alive and out of hospital at day 30
研究概览
简要总结
The goal of this randomized controlled trial is to compare total intravenous anesthesia with remimazolam vs total intravenous anesthesia with propofol in moderate-to-high risk patients undergoing major elective noncardiac surgery under general anesthesia. The primary hypothesis is that total intravenous anesthesia with remimazolam can increase days alive and out of hospital at postoperative day 30 compared with total intravenous anesthesia with propofol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥45 years;
- •Undergoing elective major surgery under general anesthesia (expected surgery time >2 h, expected length of postoperative stay >2 d);
- •Fulfilling ≥1 of the following criteria:
- •history of coronary artery disease;
- •history of stroke;
- •history of congestive heart failure;
- •preoperative NT-proBNP >200 pg/mL or BNP>92 pg/mL;
- •age ≥70 years;
- •diabetes requiring medical treatment;
- •ASA status 3 or 4;
- •history of chronic kidney disease (preoperative sCr >133 μmol/L or 1.5 mg/dL);
- •history of peripheral arterial disease;
- •preoperative serum albumin <30 g/L;
- •preoperative hemoglobin <100 g/L.
排除标准
- •Undergoing organ transplantation, cardiac, craniocerebral, burn or interventional operations;
- •Low risk or minor surgery
- •End-stage renal disease requiring renal-replacement therapy;
- •Hepatic dysfunction (Child B or C);
- •Previous liver or kidney transplantation;
- •Previous allergy to general anesthetics;
- •Unable to receive bispectral index monitoring;
- •ASA score ≥5;
- •Exposure to general anesthesia in prior 30 days or anticipated re-exposure to general anesthesia within 30 days after surgery;
- •Need for prolonged airway protection or mechanical ventilatory support after surgery;
- •Current participation in another interventional study;
- •Previous participation in this study;
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Remimazolam TIVA
Remimazolam is administered at 6-12 mg/kg/h intravenously for anesthesia induction and at 1.0-2.0 mg/kg/h for maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60.
干预措施: Remimazolam (Drug)
Propofol TIVA
Propofol 1.5-2.5mg/kg is administered intravenously for anesthesia induction and propofol at 4-12mg/kg/h is used for maintenance of general anesthesia. The dose is titrated to maintain Bispectral Index value between 40 and 60.
干预措施: Propofol (Drug)
结局指标
主要结局
Days alive and out of hospital at day 30
时间窗: 30 days after randomization
Number of days alive and out of hospital
次要结局
- All-cause 30-day mortality(30 days after randomization)
- Postoperative complications(30 days after randomization)
- Quality of Recovery-15 score on the first day after surgery(Postoperative day 1)
- Length of hospital stay(30 days after randomization)
- Unplanned re-hospitalization(30 days after randomization)