Comparison of Sugammadex vs Neostigmine in Reversal of Vecuronium induced Neuromuscular blockade
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- To assess the time taken for recovery of neuromuscular function (time to train-of-four ratio ≥ 0.9) after administration of Sugammadex versus Neostigmine.
研究概览
简要总结
Neuromuscular blocking drugs (NMBDs) are used extensively for facilitating surgical procedures and tracheal intubation during anaesthesia, concerns have been raised about the risks of postoperative residual neuromuscular blockade.Acetylcholinesterase inhibitors, such as neostigmine and edrophonium, are used for the reversal of nondepolarizing neuromuscular blockade, but they carry a risk of unwanted effects.Sugammadex, a water-soluble, modified γ-cyclodextrin, is a novel drug developed specifically for the rapid reversal of neuromuscular blockade induced by the steroidal NMBD rocuronium. Sugammadex acts by encapsulating unbound rocuronium and, to a lesser extent, also vecuronium molecules, and reducing the free NMBD fraction at the neuromuscular junction.The present study is designed to compare the efficacy and side effects of sugammadex versus neostigmine, for vecuronium-induced neuromuscular blockade in patients scheduled for elective surgery under sevoflurane anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients posted for elective surgery under General anaesthesia.
- •Stable medical condition(ASA grade l and II): Ability to provide informed consent .
排除标准
- •Allergy or contraindication to Sugammadex ,Neostigmine.
- •Unstable medical conditions (ASA grade III and IV) Recent exposure to neuromuscular blocking agents: Pregnancy or breastfeeding.
- •Patients with Neuromuscular disorders Inability to provide informed consent.
- •Participation in other studies.
结局指标
主要结局
To assess the time taken for recovery of neuromuscular function (time to train-of-four ratio ≥ 0.9) after administration of Sugammadex versus Neostigmine.
时间窗: At baseline
To compare the quality of neuromuscular recovery between Sugammadex and Neostigmine, including parameters such as the return of spontaneous ventilation, muscle strength, and reversal completeness.
时间窗: At baseline
次要结局
- To assess the time to extubation after the administration of Sugammadex versus Neostigmine.(To evaluate the incidence of adverse events associated with the use of Sugammadex and Neostigmine, including but not limited to respiratory complications, cardiovascular events, and allergic reactions.)
研究者
Mohit Sharma
Sardar Patel Medical College, Bikaner