90% Effective Dose Study of Fospropofol Disodium in Induction and Maintenance of Anesthesia in Adults of Different Ages
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Sedation score
研究概览
简要总结
Exploring the 90% effective dose (ED90) of fospropofol disodium in induction and maintenance of anesthesia in adults of different ages, providing more clinical evidence for the application of fospropofol disodium in clinical anesthesia
详细描述
As a newly marketed sedative hypnotic agent, fospropofol disodium is currently the only water-soluble precursor drug of propofol in China. It has the characteristics of long duration of action, low incidence of injection pain, respiratory and circulatory system related adverse events, and no lipid metabolism related adverse reactions, providing anesthesiologists with another sedative option during surgery. However, there are currently few clinical observation studies on this drug, and there have been no reports on its effective dosage in different age groups. Therefore, this study aims to observe the 90% effective dose (ED90) in anesthesia induction and maintenance in adults of different ages, providing effective clinical evidence for its application in clinical anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-80 years old, elective surgery under general anesthesia.
- •ASA I-II;
- •Surgical duration>30 minutes;
- •Sign an informed consent form.
排除标准
- •American Society of Anesthesiologists(ASA)≥ III;
- •Body mass index (BMI)<18 kg/m2 or>30 kg/m2;
- •Individuals with a history or potential history of drug abuse or alcohol dependence;
- •Preoperative use of sedative or analgesic drugs;
- •Individuals with severe liver and kidney dysfunction;
- •Individuals who are allergic or potentially allergic to propofol and lipids;
- •The types of surgeries that directly affect hemodynamics, such as large vessel surgery and other surgical procedures;
- •Patients with abnormal coagulation function, endocrine disorders, or other factors affecting hemodynamic status;
- •Participants in other clinical studies within the past 3 months;
- •researchers deemed it inappropriate for participants to participate in this study.
研究组 & 干预措施
Youth group
Youth group (18-45 years old)
干预措施: fospropofol (Drug)
middle-aged group
middle-aged group (46-65 years old)
干预措施: fospropofol (Drug)
elderly group
elderly group (66-80 years old)
干预措施: fospropofol (Drug)
结局指标
主要结局
Sedation score
时间窗: 1 day
Sedation score (MOAA/S)
次要结局
- Postoperative adverse reactions(1 day)