Sugammadex in Patients Undergoing Bariatric Surgery: An Equivalence Trial Comparing Real and Ideal Body Weight-based Dosing
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- 100% TOF-recovery 3 min after sugammadex
研究概览
简要总结
Should the dose of sugammadex in morbid obese patients be calculated on the real body weight or the ideal body weight?
The main objective of the trial is to compare in patients undergoing bariatric surgery the efficacy of sugammadex to obtain a TOF-ratio of 100% within 3 min when dosing is based on real body weight (control intervention) with dosing based on ideal body weight (experimental intervention). The research hypothesis is that both dosing regimens are equivalent
The secondary objective of the trial is to compare the impact of the depth of neuromuscular blockade on the surgical conditions: deep block (TOF-count 1 - 3) will be compared with very deep block (TOF count = 0 and PTC < 5)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients undergoing bariatric surgery according to the respective criteria of the French Medical Authority (HAS) and having given their written informed consent after appropriate information
排除标准
- •not fulfilling the inclusion criteria, known or suspected allergy to any of the drugs used in that study, absence of written informed consent,doubt of pregnancy in women of childbearing age, pregnancy and breast feeding
研究组 & 干预措施
deep block ideal body weight
干预措施: ideal body weight based sugammadex reversal of deep block (Drug)
deep block real body weight
干预措施: real body weight based sugammadex reversal of deep block (Drug)
moderate block ideal body weight
干预措施: ideal BW based sugammadex reversal of moderate block (Drug)
moderate block real body weight
干预措施: real body weight based sugammadex reversal of moderate block (Drug)
结局指标
主要结局
100% TOF-recovery 3 min after sugammadex
时间窗: 3 min
次要结局
- impact of depth of block on surgical conditions(every 15 min during surgery)