Pilot Study on the Pharmacodynamics of Sugammadex in Morbidly Obese Patients: Reversal of Deep Neuromuscular Blockade
试验速览
- 阶段
- 3 期
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 50% TOF-recovery 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?
To study the pharmacodynamics of sugammadex in morbidly obese patients by comparing 1 mg/kg IBW versus 1 mg/kg TBW versus placebo.
详细描述
Background of the study:
Morbidly obese patients selected for elective bariatric surgery have major anesthetic concerns. The risks include a difficult airway, difficult mask ventilation, hypoxemia, pre-existent restrictive and obstructive lung disease and residual anesthetics postoperatively due to their body habitus. In this research the investigators will focus on reversal of neuromuscular blockade to give the patient full muscle strength. Sugammadex is a A-cyclodextrin designed to encapsulate rocuronium bromide, a frequently used non-depolarizing neuromuscular blocking agent. Sugammadex provides rapid reversal of neuromuscular blockade by this encapsulation. Based on the available literature, it can be concluded that limited information is available on the use of sugammadex in morbidly obese patients. While the degree of obesity varies within the available studies, in general, the studied patients are less obese compared to the population that is currently undergoing bariatric surgery. The pharmaceutical company that produces sugammadex states that it should be dosed based on the total body weight (TBW) in all adults, regardless of the presence of obesity. However, rocuronium bromide in morbidly obese patients is dosed on ideal body weight (IBW). Therefore, the investigators hypothesize that sugammadex can be dosed based on ideal body weight instead of total body weight in morbidly obese patients. This is also relevant in economic perspective since the costs of sugammadex are high.
Objective of the study:
To study the pharmacodynamics of sugammadex in morbidly obese patients by comparing 1 mg/kg IBW versus 1 mg/kg TBW versus placebo
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- 是
入选标准
- •must have a Body Mass Index > 40 kg/m2
- •must be between 18-65 years old
- •must have an American Society of Anesthesiologists (ASA) physical status II to III
排除标准
- •Must not have Renal insufficiency identified by GFR < 60 ml/min/1.73m2
- •Sevoflurane must not be used since this can enhance neuromuscular blockade
- •No previous succinylcholine must be used in the last 24 hours
- •No use of other medication that can enhance neuromuscular blockade such as aminoglycoside- and polypeptide-antibiotics, lincosamide, acylamino-penicillin-antibiotics, tetracycline, high dose of metronidazol, M.A.O.-inhibitors, kinidine, magnesium, calcium channel blockers, lithium.
- •No use of other medication that can decrease the neuromuscular blockade such as neostigmine, edrofonium, pyridostigmine, aminopyridine derivates, chronic use of corticosteroids, phenytoïne or carbamazepine, noradrenaline, azathioprine, theophylline, calcium chloride, kaliumchloride.
- •hypersensitivity (allergic) to sugammadex or any of the preservatives.
- •an ejection fraction of less than 35%
- •Liver failure
- •Pregnancy or breastfeeding
研究组 & 干预措施
Sugammadex total body weight
1 mg/kg total body weight
干预措施: Sugammadex (Drug)
Sugammadex ideal body weight
1 mg /kg ideal body weight
干预措施: Sugammadex (Drug)
placebo
placebo 0,9% NaCl
干预措施: Placebo (Drug)
结局指标
主要结局
50% TOF-recovery after sugammadex
时间窗: 0-30 minutes
• Time to Train-of-four 50%
次要结局
- Time to TOF 5% and 25%(0-30 minutes)