Sugammadex Dosage Based on Ideal Body Weight for Profound Rocuronium-induced Neuromuscular Blockade Reversal in Morbidly Obese Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- determine a profound neuromuscular blockade reversal on ideal body weight
研究概览
简要总结
This randomized double blind clinical trial focuses on patients with Body Masse Index ≥ 40 kg/m2, undergoing scheduled surgery. Neuromuscular transmission monitoring at the adductor is performed using. Anaesthesia is induced with anaesthesic and maintained with curare. At the end of the procedure, patients with profound neuromuscular blockade receive either 1 mg/kg, 2 mg/kg or 4 mg/kg Sugammadex based on ideal body weight. A complete reversal failure is defined by a Train Of Four ratio < 0.9 within 10 min after administration of Sugammadex or if recurarization occurs within 15 min after complete reversal success.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General anaesthesia
- •Neuromuscular blockade induce by rocuronium
- •Body Masse Indice ≥ 40 kg/m2
- •informed consent
排除标准
- •Contraindication to rocuronium or sugammadex
- •Pregnant women
- •Severe renal insufficiency
研究组 & 干预措施
Sugammadex 1mg/kg
for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients
干预措施: Sugammadex 1 mg/kg (Drug)
Sugammadex 2mg/kg
for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients
干预措施: Sugammadex 2 mg/kg (Drug)
Sugammadex 4mg/kg
for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients
干预措施: Sugammadex 4 mg/kg (Drug)
结局指标
主要结局
determine a profound neuromuscular blockade reversal on ideal body weight
时间窗: 30 minutes
A complete reversal failure is defined by a Train Of Four ratio \< 0.9 within 10 min after administration of Sugammadex or if recurarization occurs within 15 min after complete reversal success
次要结局
- Compare dosages based on ideal body weight to real body weight(30 minutes)