Effects of Total Intravenous Anesthesia With Remimazolam vs Propofol on Intraoperative Hypotension in Major Noncardiac Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 65 mmHg.
研究概览
简要总结
Intraoperative hypotension is common during major noncardiac surgery and is associated with adverse postoperative outcomes. Propofol, the most commonly used intravenous anesthetic agent worldwide, is associated with hypotension on induction and maintenance of general anesthesia. Remimazolam is a newly developed short-acting benzodiazepine drug and has been approved for use in procedural sedation and general anesthesia. It was associated with a lower incidence of hypotension during procedural sedation in previous studies. The aim of this study is to tested the primary hypothesis that total intravenous anesthesia with remimazolam reduces the duration and severity of hypotension during major noncardiac surgery 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
- Prevention
- 盲法
- None
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);
- •Need for intraoperative invasive blood pressure monitoring via arterial line;
- •Fulfilling ≥1 of the following criteria (a-k):
- •history of coronary artery disease;
- •history of stroke;
- •history of congestive heart failure;
- •preoperative NT-proBNP >200 pg/mL;
- •preoperative high sensitivity troponin T > 14 ng/L;
- •age ≥70 years;
- •diabetes requiring medical treatment;
- •ASA status 3 or 4;
- •history of chronic kidney disease (preoperative sCr >133μmol/L or 1.5 mg/dL);
- •preoperative serum albumin <30 g/L;
- •preoperative hemoglobin <100 g/L.
排除标准
- •Undergoing organ transplantation, cardiac, neurological, or adrenal gland surgery;
- •Planned intraoperative MAP higher or lower than 65 mmHg;
- •Severe untreated or uncontrolled hypertension (preoperative SBP >180 mmHg and/or DBP >110 mmHg);
- •End-stage renal disease requiring renal-replacement therapy;
- •ASA score ≥5;
- •Preoperative requirement of vasopressor infusion;
- •Unable to receive bispectral index monitoring;
- •Known allergy to benzodiazepines, propofol, opioids or cisatracurium;
- •Current participation in another interventional study;
- •Previous participation in this study;
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Remimazolam TIVA
Induction: Remimazolam, sufentanil, cisatracurium. Maintenance: Remimazolam, remifentanil, cisatracurium.
干预措施: Remimazolam (Drug)
Propofol TIVA
Induction: Propofol, sufentanil, cisatracurium. Maintenance: Propofol, remifentanil, cisatracurium.
干预措施: Propofol (Drug)
结局指标
主要结局
Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 65 mmHg.
时间窗: MAP measurements are recorded every minute from of anesthesia induction to end of wound closure.
TWA-MAP under 65 mmHg for each patient is derived by dividing area under the curve (AUC)-MAP under 65 mmHg by the time interval between the first and the last MAP measurements.
次要结局
- AUC-MAP under 65 mmHg.(From of anesthesia induction to end of wound closure.)
- Duration of MAP under 65 mmHg.(From of anesthesia induction to end of wound closure.)
- Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 70 mmHg.(From of anesthesia induction to end of wound closure.)
- AUC-MAP under 70 mmHg.(From of anesthesia induction to end of wound closure.)
- Duration of MAP under 70 mmHg.(From of anesthesia induction to end of wound closure.)
- Duration of MAP under 60 mmHg.(From of anesthesia induction to end of wound closure.)
- Time-weighted average (TWA) intraoperative mean arterial pressure (MAP) under 60 mmHg.(From of anesthesia induction to end of wound closure.)
- Postoperative complications.(From end of surgery to 30 days after surgery.)
- Days alive and at home.(From end of surgery to 30 days after surgery.)
- AUC-MAP under 60 mmHg.(From of anesthesia induction to end of wound closure.)
- Postoperative quality of recovery.(At postoperative day 1.)