Study on Pharmacokinetics of Single Injection of Ciprofol in Patients With Moderate to Severe Hypoproteinemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Blood concentrations at different time points after a single injection
研究概览
简要总结
Blood concentrations of Ciprofol were measured at different time points after single injection in patients with hypoproteinemia
详细描述
This study was a single-center, interventional clinical study. Patients with different plasma albumin levels were selected before surgery and induced by a single injection of Ciprofol at a depth of 0.3 mg/kg. 2ml of venous blood was collected before and 0.5, 1, 2, 3, 5, 8, 15, 30min, 1h, 2h and 4h after administration. The pharmacokinetics of Ciprofol were studied by measuring the concentration of Ciprofol in blood.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with moderate to severe hypoproteinemia (albumin < 30g/L, protein detection time uniformly within three days before surgery）
- •Weight greater than 45kg, BMI20-24
- •The ASA rating is Class I or Class II
排除标准
- •Severe liver dysfunction
- •Severe renal dysfunction
- •Patients with ASA grade III and above
- •Known allergy to eggs, soy products, opioids and their relief drugs, propofol
- •Emergency surgery
研究组 & 干预措施
Severe Hypoproteinemia
Blood albumin concentration≤30g/L
干预措施: ciprofol (Drug)
Moderate Hypoproteinemia
Blood albumin concentration 30g/L-40g/L
干预措施: ciprofol (Drug)
Normal plasma albumin
Blood albumin concentration >40g/L
干预措施: ciprofol (Drug)
结局指标
主要结局
Blood concentrations at different time points after a single injection
时间窗: Before administration, after administration 0.5 minute, 1 minute, 2 minutes, 3 minutes, 5 minutes, 8 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours
Blood concentration of ciprofol
次要结局
- Onset time of ciprofol in patients with hypoproteinemia(Day 1)
- Effect time of ciprofol in patients with hypoproteinemia(Day 1)
研究者
Xie Kangjie
Clinical Professor
Zhejiang Cancer Hospital