Comparison of Remimazolam and Propofol Anesthesia on Hemodynamic and Recovery Profile in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- difference in the decreased mean arterial pressure
研究概览
简要总结
Remimazolam is a recently developed ultra-short agonist acting at the benzodiazepine binding site of the gamma-aminobutyric acid (GABA)A receptor. Remimazolam has a combination of the hemodynamic stability of benzodiazepines and the advantages of propofol, such as rapid onset, short duration of action, and improved controllability.
A recent study showed that the efficacy of two induction doses of remimazolam (6 and 12 mg/kg/h) as a sedative for general anesthesia was not inferior to propofol (2.0-2.5 mg/kg), and hemodynamically more stable. On the other hand, a study on the emergence time and quality between propofol and remimazolam showed inconsistent results.
The purpose of this study is to compare remimazolam to propofol on the intraoperative hemodynamic changes and recovery profiles, when used in combination with remifentanil in elderly patients undergoing general anesthesia.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I, II patients over 65 years old undergoing general anesthesia
排除标准
- •cardiac surgery
- •neurosurgery
- •liver surgery
- •uncontrolled hypertension
- •bronchial asthma
- •body mass index ≥ 30 kg/m2
- •severe heart, liver, kidney disease
研究组 & 干预措施
Remimazolam 6
Remimazolam starts at 6 mg/kg/hr until loss of consciousness
干预措施: Remimazolam Besylate 6 mg/kg/hr (Drug)
Remimazolam 12
Remimazolam starts at 12 mg/kg/hr until loss of consciousness
干预措施: Remimazolam Besylate 12 mg/kg/hr (Drug)
Propofol
Propofol starts at a target controlled infusion 4 µg/ml until loss of consciousness.
干预措施: Propofol (Drug)
结局指标
主要结局
difference in the decreased mean arterial pressure
时间窗: from the start of anesthetics (propofol or remimazolam) injection to the 5 minutes after extubation
difference between baseline mean arterial pressure and lowest mean arterial pressure
次要结局
未报告次要终点
研究者
Jong Yeop Kim
Professor
Ajou University School of Medicine