Effect of Remimazolam-remifentanil Versus Propofol-remifentanil Based General Anesthesia on Intraoperative Hemodynamic Stability in Prone Position for Major Spine Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- the number of hypotensive episode per patient
研究概览
简要总结
Most of the major spinal surgeries are performed in the supine position, which causes a decrease in stroke volume and cardiac index, which leads to the occurrence of hypotension during surgery. Postoperative hypotension causes an imbalance in the supply and demand of oxygen, leading to postoperative myocardial infarction or acute renal damage, and may increase mortality one year after surgery. Propofol, which is most commonly used for total intravenous anesthesia, can further increase the incidence of hypotension during surgery. Therefore, there is a continuing demand for an anesthetic agent that is more hemodynamically stable. Remimazolam, an ultra-short acting benzodiazepine that has a similar structure to midazolam, but whose activity is terminated by esterase hydrolysis, is expected to have less hemodynamic effects than propofol. Therefore, the purpose of this study is to investigate the effect of general anesthesia using remimazolam and general anesthesia using propofol on hemodynamic safety during surgery in patients undergoing major spinal surgery in the supine position.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status: 1-3
- •age: 19-80 years
- •patients who are scheduled to undergo a major spine surgery in the prone position
排除标准
- •patients who refuse to participate
- •body mass index: <15kg/m2 or >35kg/m2
- •patients with uncontrolled hypertension, hyperthyroidism, severe cardiac disease
- •patients who are contraindicated to the use of remimazolam including severe hepatic disease, acute glaucoma, shock, acute alcohol intoxication
- •allergic to propofol and midazolam
- •patients who are judged unsuitable to participate in the study for other reasons by medical staffs
研究组 & 干预措施
remimazolam group
patients who receive remimazolam-remifentanil based total intravenous anesthesia
干预措施: Remimazolam (Drug)
propofol group
patients who receive propofol-remifentanil based total intravenous anesthesia
干预措施: Propofol (Drug)
结局指标
主要结局
the number of hypotensive episode per patient
时间窗: for one hour after turning the patients to the prone position
SAP \< baseline SBP \* 80% or 90mmHg // MAP \< baseline MAP \* 80% or 65mmHg
the number of severe hypotensive episode per patient
时间窗: for one hour after turning the patients to the prone position
SAP \< baseline SBP \* 70% or 80mmHg // MAP \< baseline MAP \* 70% or 55mmHg
次要结局
- heart rate(for one hour after turning the patients to the prone position)
- cardiac output(for one hour after turning the patients to the prone position)
- Total opioid consumption(for one hour after turning the patients to the prone position)
- pleth variability index(for one hour after turning the patients to the prone position)
- stroke volume(for one hour after turning the patients to the prone position)
- cardiac index(for one hour after turning the patients to the prone position)
- stroke volume variation(for one hour after turning the patients to the prone position)
研究者
Hajung Kim
Clinical Assistant Professor
Asan Medical Center