Comparison of Hemodynamic Stability During Anesthesia Using Remimazolam and Sevoflurane in Patients Undergoing Minimally Invasive Aortic Valve Replacement Surgery : A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Total dose of vasopressors and inotropics used.
研究概览
简要总结
Anesthetic agents can cause hypotension, and be especially dangerous in patients with severe aortic stenosis, which can lead to even circulatory collapse. Remimazolam is known for its hemodynamic stability compared to propofol. This study is designed to compare effects of remimazolam vs. sevoflurane anesthesia on intraoperative hemodynamics in patients with severe aortic valve stenosis.
详细描述
Anesthetic agents can cause hypotension due to reduced cardiac contractility and vasodilation. This can be especially dangerous in patients with severe aortic stenosis, which can lead to even circulatory collapse in extreme cases. Remimazolam is a relatively new anesthetic agent and it is a ultra-short acting benzodiazepine with a context sensitive half time of 7.5 minutes. Remimazolam is known for its hemodynamic stability compared to propofol. Previous studies have also shown that remimazolam can be safely used in patients with severe aortic stenosis and in cardiac anesthesia induction and during cardiopulmonary bypass. However, there is no definite data on comparison of hemodynamic variables between remimazolam based total intravenous anesthesia (TIVA) and conventional propofol induction and sevoflurane maintenance anesthesia. Therefore, this study is designed to compare effects of remimazolam vs. sevoflurane anesthesia on intraoperative hemodynamics in patients undergoing minimally invasive aortic valve replacement surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Patients over 19 years old
- •Patients with severe aortic stenosis, undergoing minimally invasive aortic valve replacement surgery
排除标准
- •Patients with known allergy to benzodiazepine, flumazenil, propofol
- •Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •Patients with hypersensitivity to Dextran40
- •Patients who have been taking benzodiazepine for long term
- •Patients with whom heart rate assessment is not accurate, such as atrial fibrillation
- •Patients with end stage renal disease requiring hemodialysis
- •Patients with history of acute angle glaucoma
- •Patients with valve disease severity of grade III or higher, other than aortic valve
- •Emergency operation
研究组 & 干预措施
Remimazolam
Induction dose of 6 mg/kg/h of remimazolam with remifentanil TCI 1~4 nanogram/mL are injected together. When patient loses consciousness, rocuronium 0.8 mg/kg is given and endotracheal intubation is performed after confirming that TOF count is less than one. Anesthesia is maintained by using remimazolam dose of 1mg/kg/h~2mg/kg/h with remifentanil to maintain optimal depth of anesthesia, which will checked by Sedline value between 25 to 50.
干预措施: Remimazolam besylate (Drug)
Propofol/sevoflurane
1% propofol 1-2mg/kg is injected with remifentanil TCI 1~4, and when patient loses consciousness, sevoflurane is started and rocuronium 0.8mg/kg is given. After confirming that TOF count is less than one, intubation is performed and anesthesia is maintained with sevoflurane and remifentanil to keep the Sedline value between 25 and 50.
干预措施: Propofol/ Sevoflurane (Drug)
结局指标
主要结局
Total dose of vasopressors and inotropics used.
时间窗: Start of anesthesia to end of anesthesia
Total dose of vasopressors and inotropics used during anesthesia will be compared between two groups.
次要结局
- Hypotension and bradycardia event duration(Start of anesthesia to end of anesthesia)
- Extubation time(End of anesthesia to extubation)
- Emergence agitation(Arrival of patient at ICU)
研究者
Kim Hee Young
Assistant professor for fund
Pusan National University Yangsan Hospital