Efficacy and Safety of Sugammadex (Bridion™) in the Reversal of Profound Rocuronium-induced Neuromuscular Blockade in Patients With End-stage Renal Failure: Comparison With Healthy Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.9
研究概览
简要总结
The purpose of this study is to determine whether sugammadex reverses a profound neuromuscular blockade induced by rocuronium in patients with end-stage renal disease just as effectively and safely as it does in patients with normal renal function.
详细描述
Sugammadex antagonizes rocuronium induced neuromuscular blockade by encapsulating the molecules of this agent in the plasma and originating a complex which is highly stable, and mainly eliminated by the kidneys. In patients with end stage renal disease, this complex remains in the circulation for days. Previous studies have shown that sugammadex adequately reverses the blockade induced by rocuronium in such patients, and no evidence of recurrence was observed after a dosis of 2 mg/Kg administered to reverse a moderate level of blockade. To our knowledge, nothing has been published so far on the reversal of profound blockade by sugammadex in patients with renal failure.
The aim of our study was to evaluate the efficacy and safety of sugammadex in the reversal of profound neuromuscular block (NMB) induced by rocuronium in patients with end-stage renal failure and compare it to patients with normal renal function.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 65 years old
- •end-stage renal disease defined by clearance of creatinine < 30 ml/min
- •normal renal function defined by clearance if creatinine > 90 ml/min
- •candidates to elective surgical procedures (control group) or kidney transplantation (renal group) under general anaesthesia
排除标准
- •pregnant and breastfeeding women
- •patients with known or suspected neuromuscular disorders
- •patients with hepatic disfunction
- •a history of malignant hyperthermia
- •allergy to narcotics, rocuronium or other medication used during general anaesthesia
- •patients receiving medication known to interfere with the action of rocuronium (amino glycoside antibiotics, anticonvulsants, or magnesium)
研究组 & 干预措施
Renal Group
Sugammadex (4mg/Kg) single dose to reverse profound neuromuscular blockade
干预措施: Sugammadex (4 mg/Kg) (Drug)
Control group
Sugammadex (4mg/Kg) single dose to reverse profound neuromuscular blockade
干预措施: Sugammadex (4 mg/Kg) (Drug)
结局指标
主要结局
Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.9
时间窗: 2 hours
次要结局
- Time from administration of sugammadex to recovery of the train-of-four ratio (TOF) to 0.7 and 0.8(2 hours)
研究者
Camila Machado de Souza
MD
Federal University of São Paulo