Pharmacokinetics and Pharmacodynamics of Sugammadex Dosed by Corrected Body Weight for Reversal of Vecuronium in Obese Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Plasma Concentration of Sugammadex
研究概览
简要总结
The purpose of this study is to illustrate pharmacokinetics of sugammadex in reversal of vecuronium-induced neuromuscular blockade in patients during laparoscopic surgery
详细描述
48 patients undergoing laparoscopic surgery were divided into 3 groups according to body mass index (BMI), including normal weight group(A group,n=16,18.5kg/m² ≤ BMI ≤ 24.9kg/m²),obese group (B group, n=16, 25≤BMI≤39.9kg/m²) and morbidly obese group (C group, n=16, BMI≥40kg/m²).
Vecuronium was continuous infusing to maintain moderate neuromuscular blockade during the laparoscopic surgery and stopped infusing after the laparoscopic procedure. A single dose administration of sugammadex (Sug) 2.0mg/kg according to ideal body weight (IBW) was given at the reappearance of the second twitch of the train-of-four (TOF) response.
On one hand, venous blood samples were obtained before administration of Sug and at 2, 3, 5, 10, 15, 20, 30, 60 minutes and 2, 4, 6, 8 hours after administration of Sug to determine plasma concentration of Sug using HPLC-MS. On the other hand, time from start of administration of Sug to recovery of TOF ratio to 0.9 and other clinical indicators were also recorded.
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
- 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
- 否
入选标准
- •BMI≥25kg/m²
- •Patients receiving bariatric surgery.
排除标准
- •Pregnant or lactating women
- •Neuromuscular diseases
- •Malignant hyperthermia or allergic history during general anesthesia
- •Drugs that react with rocuronium and vecuronium were taken
研究组 & 干预措施
Normal Weight group
n=16, 18.5kg/m² ≤ BMI ≤ 24.9kg/m²
干预措施: Sugammadex (Drug)
Morbidly Obese group
n=16, BMI≥40kg/m²
干预措施: Sugammadex (Drug)
Obese group
n=16, 25≤BMI≤39.9kg/m²
干预措施: Sugammadex (Drug)
结局指标
主要结局
Plasma Concentration of Sugammadex
时间窗: 0, 2, 3, 5, 10, 15, 20, 30, 60 minutes and 2, 4, 6, 8 hours
venous blood samples were obtained
TOF ratio of Recovery Time
时间窗: TOF ratio at 30, 60, 90, 120, 150 seconds after administration
time from start of administration of Sug to recovery of TOF ratio to 0.9 and other indicators
次要结局
未报告次要终点
研究者
bo xu
Clinical Professor
Guangzhou General Hospital of Guangzhou Military Command