Randomized, Parallel-group, Placebo-controlled, Safety-assessor Blinded Trial in Adult Subjects Evaluating the Efficacy and Safety of Sugammadex for Reversal of Pipecuronium-induced Neuromuscular Blockade in Subjects Undergoing Abdominal Surgery Under General Anesthesia
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- time from the start of sugammadex or placebo administration (reappearance of T2) to recovery of the TOF ratio to 0.9
研究概览
简要总结
Primary objectives:
- to investigate the efficacy of sugammadex in dose of 4 mg/kg administered at reappearance of T2 for reversal of pipecuronium-induced neuromuscular blockade in subjects undergoing abdominal surgery under general anesthesia
- to evaluate the safety and tolerability of a single dose of 4 mg/kg sugammadex administered at reappearance of T2 for reversal of pipecuronium-induced neuromuscular blockade
Secondary objectives:
- to evaluate the time from the start of sugammadex or placebo administration to the time of extubation and to the time of recovery of TOF ratio to ≥ 0.9
Exploratory objectives:
- to evaluate the Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay after the end of surgery in subjects with pipecuronium induced neuromuscular blockade reversed by 4.0 mg.kg-1 sugammadex compared to placebo (saline)
- compare the number of patients extubated in the OR after the reversal by sugammadex or placebo, evaluate the TOF ratio at the time of extubation
Clinical hypothesis:
- Sugammadex has to be effective and well tolerated for reversal of pipecuronium-induced blockade
详细描述
Sugammadex is the first selective relaxant binding agent indicated for reversal of rocuronium and vecuronium-induced blockade.
At the same time sugammadex is able to form the complexes with other aminosteroid-based muscle relaxants including long acting NMBAs* such as pancuronium 1,2.
Still there are only limited data on the efficacy of sugammadex with pancuronium and no data on the efficacy of sugammadex with other aminosteroid-based long acting NMBA - pipecuronium which is still widely used in Russia (as well as in the other former Soviet Union Countries and Eastern Europe countries). In the only study evaluating efficacy of sugammadex with pancuronium has been shown that moderate pancuronium-induced blockade is effectively reversed in less than 3 minutes with a sugammadex dose of 4.0 mg/kg 3. In this respect it would be interesting in this study to evaluate the efficacy of sugammadex with pipecuronium.
It is also very well known that the incidence of postoperative residual blockade (and its complications) is higher when the long acting NMBAs such as pancuronium and pipecuronium are used 4,5,6,7. So the possibility to use sugammadex for reversal of pipecuronium-induced blockade could help to reduce the incidence of residual blockade and related complications.
The effectiveness of sugammadex for the reversal of long acting NMBAs such as pipecuronium at the same time would be significant in light of the limitations of cholinesterase inhibitors. These drugs are more often administered after the long acting NMBAs taking into account their prolonged clinical duration of action.
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
- Single (Investigator)
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
- •Subjects of ASA class 1-3
- •Subjects of age ≥ 18 years
- •Subjects undergoing abdominal surgery under general anesthesia who receives succinylcholine for tracheal intubation and pipecuronium for maintenance of neuromuscular blockade
- •Subjects who have given written informed consent
排除标准
- •Subjects in whom a difficult intubation is expected
- •Subjects known or suspected to have neuromuscular disorders affecting NMB
- •Subjects known or suspected to have a significant renal dysfunction or a severe hepatic dysfunction
- •Subjects known or suspected to have (family) history of malignant hyperthermia
- •Subjects known or suspected to have an allergy to opioids, muscle relaxants or other medication used during general anesthesia
- •Female subjects who are pregnant
- •Female subjects who are breast-feeding
研究组 & 干预措施
sugammadex group
4 mg/kg of sugammadex for reversal of pipecuronium-induced neuromuscular blockade
干预措施: sugammadex (Drug)
placebo group
3 ml of saline (placebo) for reversal of pipecuronium-induced neuromuscular blockade
干预措施: placebo (Drug)
结局指标
主要结局
time from the start of sugammadex or placebo administration (reappearance of T2) to recovery of the TOF ratio to 0.9
时间窗: during peri-anesthetic period (after the surgery and until 10 hours after the surgery)
measurement of time from the start of sugammadex or placebo administration (reappearance of T2) to recovery of the TOF ratio to 0.9
次要结局
- time from the start of sugammadex or placebo administration to the time of extubation(during peri-anesthetic period (after the surgery and until 10 hours after the surgery)
研究者
Eduard Nikolaenko
Professor Nikolaenko
Central Clinical Hospital #1 of LLC Russian Railways