Comparison of Three Different Doses Sugammadex Based on Ideal Body Weight for Reversal of Moderate Rocuronium-induced Neuromuscular Blockade in Laparoscopic Bariatric Surgery.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- sugammadex time following a dose of 1.5 mg / kg of sugammadex according to IBW in comparison to 2, and 4 mg / kg,
研究概览
简要总结
the investigators aimed to compare the efficacy and safety of sugammadex at doses of 1.5, 2, and 4 mg/ kg for the reversal of moderate rocuronium-induced neuromuscular blockade in laparoscopic bariatric surgery.
详细描述
Patients were randomly assigned using a randomization-computer program into three groups according to the dose of sugammadex administrated (according to the IBW after T2 of TOF):
Group I: patients were given 1.5 mg / kg. Group II: patients were given 2 mg / kg. Group III: patients were given 4 mg / kg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
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
- •morbidly obese patients of both sex (BMI > 40 kg.m-2)
- •scheduled for elective laparoscopic bariatric surgery (gastric bypass or sleeve surgery) under general anesthesia using rocuronium for tracheal intubation and maintenance of NMB
- •aged between 18 and 60 years and classified as ASA II - III
排除标准
- •liver and renal dysfunction,
- •disabling neuropsychiatric disorders,
- •history of stroke, brain trauma in the last 12 months
- •hypersensitivity to anesthetics, history of myocardial infarction, congestive heart failure
- •difficult tracheal intubation, and known or suspected disorder affecting NMB.
研究组 & 干预措施
group 1
patients were given 1.5 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)
干预措施: sugammadex reversal of neuromuscular blockade (Drug)
group II
patients were given 2 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)
干预措施: sugammadex reversal of neuromuscular blockade (Drug)
group III
patients were given 4 mg / kg. of sugammadex administrated (according to the IBW after T2 of TOF)
干预措施: sugammadex reversal of neuromuscular blockade (Drug)
结局指标
主要结局
sugammadex time following a dose of 1.5 mg / kg of sugammadex according to IBW in comparison to 2, and 4 mg / kg,
时间窗: 2 hrs
次要结局
- extubation time(2 hrs)
研究者
Fatma Adel El sherif
principal investigator
Assiut University