Effect of Remimazolam and Propofol on Hemodynamic Stability During Anesthesia Induction in Patients Undergoing Coronary Artery Bypass Grafting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- MAP-time integral
研究概览
简要总结
Remimazolam is a novel ultra-short-acting benzodiazepine. Several studies demonstrated that its efficacy as a sedative hypnotics for general anesthesia is non-inferior to propofol. However, evidence on the hemodynamic stability of remimazolam for the anesthesia induction in patients undergoing coronary artery bypass grafting is lacking. This prospective randomized trial aims to compare hemodynamic stability during anesthesia induction between remimazolam and propofol in patients undergoing coronary artery bypass grafting.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (aged 19 years or older) who scheduled for elective coronary artery bypass grafting
排除标准
- •Patients who refuse to participate
- •Concomitant heart valve surgery or thoracic aorta surgery
- •Emergent surgery
- •Preoperative sedation
- •Intubated state
- •Patients with mechanical circulatory assist device
- •Preoperative use of inotropes or vasopressors
- •History of allergy or adverse reaction to study drugs
- •Rapid sequence intubation
- •Lactose intolerance
- •Peanut allergy
研究组 & 干预措施
Propofol
干预措施: Sufentanil (Drug)
Remimazolam
干预措施: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO] (Drug)
Remimazolam
干预措施: Rocuronium (Drug)
Remimazolam
干预措施: Sufentanil (Drug)
Propofol
干预措施: Propofol (Drug)
Propofol
干预措施: Rocuronium (Drug)
结局指标
主要结局
MAP-time integral
时间窗: During 10 minute from the administration of the study drug
The area under the baseline MAP (sec \* mmHg). Baseline MAP was defined as the mean MAP over the 3 min period immediately before induction.
次要结局
- Time to loss of consciousness(During 10 minute from the administration of the study drug)
- Phenylephrine dose(During 10 minute from the administration of the study drug)
- Study drug dose(During 10 minute from the administration of the study drug)
- Ephedrine dose(During 10 minute from the administration of the study drug)
- Vasopressin dose(During 10 minute from the administration of the study drug)
- Regional cerebral oxygen saturation(During 10 minute from the administration of the study drug)
- Cardiac output(During 10 minute from the administration of the study drug)
- Sufentanil dose(During 10 minute from the administration of the study drug)
- Heart rate(During 10 minute from the administration of remimazolam or propofol)
- Crystalloid(During 10 minute from the administration of the study drug)
- Mean blood pressure(During 10 minute from the administration of the study drug)
- Number of vasopressor administration(During 10 minute from the administration of the study drug)
- Norepinephrine dose(During 10 minute from the administration of the study drug)
研究者
Yunseok Jeon
Professor
Seoul National University Hospital