Safety and Effectiveness of Ciprofol in Cardiac Surgery Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean arterial pressure
研究概览
简要总结
Ciprofol, a novel intravenous general anesthetic with a chemical structure akin to propofol, boasts significantly enhanced potency. It offers a rapid onset, reduced incidence of injection pain, and minor impact on the cardiovascular system. However, clinical research regarding ciprofol's use for anesthesia induction in cardiac surgery remains limited. The investigators want to assesse the safety and effectiveness of ciprofol in cardiac surgery 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective surgery patients
- •Aged 55 to 75
- •New York Heart Association class II or III cardiac functions
- •Median sternotomy approach for coronary artery bypass grafting or heart valve replacement procedures.
排除标准
- •With a history of benzodiazepine allergy
- •Significant liver or kidney insufficiency
- •Coagulation dysfunction
- •Neurological or psychiatric disorders
- •Undergone major surgery within the past three months.
研究组 & 干预措施
ciprofol
干预措施: ciprofol injection (Drug)
propofol
干预措施: Propofol injection (Drug)
结局指标
主要结局
Mean arterial pressure
时间窗: 5 minutes after tracheal intubation (T4)
an average blood pressure in an individual during a single cardiac cycle
Heart beats
时间窗: 5 minutes after tracheal intubation (T4).
the number of times each minute that heart beats
次要结局
- Oxygenation index(10 minutes after tracheal intubation (T5).)
- Injection pain(During procedure (When injecting the drug, ask the subject if the injection site is painful))
研究者
Le Yu
Clinicians
Shanghai East Hospital of Tongji University