Effect of Laparoscopic Operation on Rocuronium and Cisatracurium: Pharmacokinetic and Pharmacodynamic Analysis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- the blood flow in the right and middle hepatic veins
研究概览
简要总结
The investigators investigated whether laparoscopic versus open surgical approaches affected the pharmacokinetic and pharmacodynamic of a single bolus dose of rocuronium or cisatracurium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology 1-2
- •BMI 18-30 kg.m-2
- •elective gynaecological operations under general anaesthesia
排除标准
- •cirrhosis
- •hepatitis
- •heart failure
- •arrhythmia
- •renal dysfunction
- •electrolyte disturbances
- •acid-base imbalances
- •neuromuscular disorders
研究组 & 干预措施
laparoscopic operation on rocuronium
according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group.
干预措施: rocuronium (Drug)
laparoscopic operation on cisatracurium
according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group.
干预措施: cisatracurium (Drug)
conventional open surgery on rocuronium
according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group.
干预措施: rocuronium (Drug)
conventional open surgery on cisatracurium
according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group.
干预措施: cisatracurium (Drug)
结局指标
主要结局
the blood flow in the right and middle hepatic veins
时间窗: up to 9 months
Measurements of the blood flow in the right and middle hepatic veins were performed at baseline and 1,5, 10, 20, 30min after insufflation of carbon dioxide or incise the skin as well as 1 and 5 min after deflation or close the wound.
次要结局
- the plasma Concentration of rocuronium and cisatracurium(up to 9 months)
研究者
Tingting Wang
Tingting Wang
Fudan University