The Efficacy and Safety of Remimazolam Besylate for Cardiac Anesthesia
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 320
- 主要终点
- ratio of successful sedation during the whole surgery
研究概览
简要总结
The evidence on the practice of remimazolam besylate during cardiac anesthesia is scarce. This study investigates the efficacy and safety of remimazolam besylate general induction and maintenance during cardiac surgery.
详细描述
Remimazolam besylate (RB), as a new benzodiazepine sedative agent, has been approved in clinical anesthesia with prominent characteristics of short onset/offset, less depression for cardiovascular or respiratory function and specific antagonist. Some studies have confirmed the comparable anesthesia efficacy of remimazolam for outpatient digestive endoscopy, fiberoptic bronchoscopy, facial plastic and orthopedic surgery as propofol. Currently, the evidence on its application in cardiac anesthesia is insufficient. Our study aims to evaluate the efficacy of remimazolam besylate and propofol and provide an ideal anesthetic agent to achieve the goal of early recovery after cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective cardiac surgery via cardiopulmonary bypass;
- •Aged 18-65 years;
- •American Society of Anesthesiologists (ASA) grade I-III;
- •Body mass index (BMI) 18-28 kg/m2.
排除标准
- •A history of sternotomy for heart disease;
- •Angina or arrhythmia with severe dynamics flutters pre-operation;
- •Respiratory, hepatic or renal dysfunction (oxygenation index<300, alanine transaminase> 2 upper limits of normal value, creatinine > 200 μmol/L);
- •Diagnosed with advanced tumors;
- •Psychiatric or mental disorders;
- •Myasthenia gravis or seizures;
- •Pregnant or lactating females;
- •A history of benzodiazepines administration within 3 months before surgery;
- •Known allergic to benzodiazepines, opioids, propofol and flumazenil;
- •Involved in another interventional clinical trial.
研究组 & 干预措施
remimazolam besylate
Patients received an initial dose of remimazolam (0.3mg/kg) for induction and a continuous infusion rate of 1 mg/kg/h for anesthesia maintenance.
干预措施: remimazolam besylate (Drug)
propofol
Patients received an initial dose of propofol (1.0 mg/kg) and a continuous infusion rate of 1-1.5 mg/kg/h
干预措施: propofol (Drug)
结局指标
主要结局
ratio of successful sedation during the whole surgery
时间窗: Intraoperative period
Sedation success is defined as BIS locating in the range of 40-60 according to the required dosage without additional rescue sedative during the surgical procedures.
次要结局
- time interval for BIS from baseline before induction to 60(Intraoperative period)
研究者
SHI Jia
director of department of Anesthesiology
Chinese Academy of Medical Sciences, Fuwai Hospital