Safety and Efficacy of Remimazolam in Induction and Maintenance of General Anesthesia in OPCAB Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- cardiac index (T4)
研究概览
简要总结
Remimazolam is a novel short-acting benzodiazepine drug that acts on the benzodiazepine binding site of gamma-aminobutryic acid (GABA) A receptor, is metabolized by esterase, and has a context-sensitive half-time of about 6-7 minutes. Looking at some previous studies using Remimazolam, the safety and efficacy as a general anesthetic have been sufficiently proven.
In particular, compared to intravenous anesthetic agents such as propofol, the action time of anesthetics is relatively longer, but the frequency of hypotension is low. However, most studies have been conducted on patients of American Society Anesthesiologist (ASA) class I-II, and studies on patients with high severity have not yet been sufficiently secured.
Therefore, this study aims to compare the efficacy and safety of Remimazolam as an anesthetic with Sevoflurane in terms of hemodynamics in patients with high severity undergoing OPCAB 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
- •Adult patients 19 years of age or older to receive OPCAB surgery
- •Clinical diagnosis of coronary artery obstructive disease
排除标准
- •Ejection fraction < 35% at preoperative ECHO test
- •Mitral regurgitation > grade 2 at preoperative ECHO test
- •Currently using inotropics
- •Currently receiving mechanical support
研究组 & 干预措施
remimazolam group
In the Remimazolam group as an induction dose 6 mg/kg/h of remimazolam with 0.5-1.0 mcg/kg of sufentanil was injected together. If consciousness was lost, rocumerone 1 mg/kg was given intravenously, and endotracheal intubation was performed when sufficient muscle relaxation was achieved 2 minutes later.
Maintenance of anesthesia is achieved by using a programmed infusion pump with remimazolam 1 mg/kg/h (up to 2 mg/kg/h) and sufentanil effect site concentration of 0.4 to 0.5 to reach the appropriate depth of anesthesia. The optimal level of anesthesia is based on maintaining a bispectral index (BIS) of 35-65.
干预措施: Remimazolam Injection [Byfavo] (Drug)
sevoflurane group
After injection of 2-5 mg of midazolam and 0.5-1.0 mcg/kg of sufentanil as an induction dose, 1 mg/kg of rocumerone is given intravenously when consciousness is lost, and endotracheal intubation is performed when sufficient muscle relaxation is achieved 2 minutes later. For maintenance of anesthesia, the concentration of sevoflurane and sufentanil effect site concentration is 0.4 to 0.5 to reach the appropriate depth of anesthesia, and the optimal degree of anesthesia is based on maintaining the BIS 35 to 65.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
cardiac index (T4)
时间窗: 5 minutes before operation
The cardiac index (CI) at that time was measured and compared between the two groups.
cardiac index (T5)
时间窗: 10 minutes after starting left internal mammary artery dissection
The cardiac index (CI) at that time was measured and compared between the two groups.
cardiac index (T6)
时间窗: 10 minutes after starting left anterior descending coronary artery anastomosis
The cardiac index (CI) at that time was measured and compared between the two groups.
cardiac index (T7)
时间窗: 10 minutes after starting Y-graft anastomosis of graft vessels
The cardiac index (CI) at that time was measured and compared between the two groups.
次要结局
- NE dose(During surgery(from induction of anesthesia to end of surgery))
- Incidence of hypotension(During surgery(from induction of anesthesia to end of surgery))
研究者
Jiyoung Yoo
associate professor
Ajou University School of Medicine