A comparative efficacy between Sugammadex and Neostigmine plus Glycopyrronium bromide for the reversal of Vecuronium induced Neuromuscular blockade: A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- 1.To compare the efficacy between Sugammadex and Neostigmine plus Glycopyrronium bromide to time of recovery of TOF ratio to 0.9.
研究概览
简要总结
Introduction: Neuromuscular blocking agents are widely used to facilitate endotracheal intubation, ease mechanical ventilation, and optimize surgical conditions. Neostigmine is a commonly used acetylcholinesterase inhibitor,which competitively antagonizes residual neuromuscular blockade by preventing metabolism of acetylcholine.Sugammadex is a gamma-cyclodextrin drug that reverses non-depolarising neuromuscular blockade, induced Vecuronium.It has been compared with acetyl-cholinesterase inhibitors, mainly Neostigmine. Sugammadex, unlike Neostigmine, does not inhibit acetylcholinesterase, hence co-administration of an antimuscarinic agent is not needed.We propose to undertake this study to compare the time taken to recover from neuromuscular blockade.
Aim and Objectives:
1.To compare the efficacy between Sugammadex and Neostigmine plus Glycopyrronium bromide for reversal of Vecuronium induced neuromuscular blockade.
2.To compare the efficacy of study drug administration to time of recovery of TOFr to 0.9
and clinical signs of recovery after tracheal extubation.
Material and Methods: This will be a double blinded and randomized controlled trial conducted on 84 patients undergoing elective surgery at Christian Medical College & Hospital, Ludhiana. The patients will be divided into two groups of 42 patients each:
Group A: Reversal with Sugammadex
Group B: Reversal with Neostigimine plus Glycopyrronium bromide.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.ASA (American Society of Anaesthesiologists) I and II 2.All men and women.
- •3.Adult 18-60 years.
- •4.Elective General surgeries, Orthopedic, Laproscopic, Gynecological surgeries under general anaesthesia lasting for 2-3 hours.
- •5.Planned use of neuromuscular blocking drugs.
- •6.Planned endotracheal intubation and extubation in operating room.
排除标准
- •1.Anticipation of difficult airway.
- •2.Known or suspected neuromuscular disorder impairing neuromuscular function.
- •3.Allergy to muscle relaxants.
- •4.A personal or family history of malignant hyperthermia.
- •5.Pregnant females, breast feeding mothers, or females in childbearing age using contraceptives.
- •6.Renal impaired patients.
结局指标
主要结局
1.To compare the efficacy between Sugammadex and Neostigmine plus Glycopyrronium bromide to time of recovery of TOF ratio to 0.9.
时间窗: Under minimal block, time taken for extubation is recorded at intervals of 5 mins, 10mins,15mins and so on.
次要结局
- Post reversal physiological characteristics- Blood pressure, Heart rate, Spo2, Respiratory rate.(At the interval of 0mins, 10mins, 20mins, 30mins, 60mins, 120mins)