Sugammadex ED90 Dose to Reverse the Rocuronium Blockade in the Obese Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 主要终点
- Sugammadex ED90
研究概览
简要总结
The purpose of this study is to determine the minimum effective dose of sugammadex, an antagonist of neuromuscular blockade used during anesthesia practice, in obese patients, considering that sugammadex is indicated in adults with normal weight at a dose of 2 mg/kg but no studies were found with obese patients.
详细描述
Prospective study with the sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).
The following doses were chosen: 2.0 mg.kg-1, 2.2 mg.kg-1, 2.4 mg.kg-1, 2.6 mg.kg-1, 2.8 mg.kg-1.
The complete reversal of moderate rocuronium-induced neuromuscular blockade (NMB) considered a T4/T1 ratio ≥ 0.9 with the peripheral nerve stimulator and accelerometer (monitor of sequential electric stimuli) "train-of-four" (TOF).
After induction of general anesthesia and the calibration of the peripheral nerve stimulator and accelerometer, rocuronium 0.6 mg.kg-1 was injected.
Continuous intravenous infusion of the anesthetics propofol and remifentanil, and intermittent bolus of rocuronium were offered throughout the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a body mass index ≥ 40 kg/m2
- •bariatric surgery
- •informed consent signed
排除标准
- •history of neuromuscular diseases,
- •use of drugs that could interfere with neuromuscular transmission,
- •allergy to neuromuscular agents of the aminosteroids class,
- •anticipated difficulty in airway management,
- •renal failure
研究组 & 干预措施
sugammadex ED90
Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).
The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.
干预措施: sugammadex ED90 (Drug)
结局指标
主要结局
Sugammadex ED90
时间窗: 8 minutes
Complete reversal of neuromuscular blockade occured when the patient had a TOF T4/T1 ≥ 0.9 within eight minutes of sugammadex infusion. The sequencial design method of up-and-down was applied to determine the minimum effective dose in 90% of patients (ED90). An effective dose is one that achieves complete reversal of neuromuscular blockade that is defined as a measure of TOF equal or higher than 0.9, or a relationship between T4 an T1 measure ≥ 0.9, within eight minutes of sugammadex infusion.
次要结局
未报告次要终点
研究者
Mauro Prado da Silva
MD, Staff
Faculdade de Ciências Médicas da Santa Casa de São Paulo