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临床试验/CTRI/2024/11/076207
CTRI/2024/11/076207已完成不适用

Comparison of Sugammadex vs Neostigmine for reversal of Vecuronium induced Neuromuscular Blockade A Randomised Controlled Study

Department of anaesthesia1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年11月8日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Sugammadex provides significantly Faster Reversal Of Vecuronium Induced Neuromuscular Blockade

研究概览

简要总结

: After surgery, reversal drugs such as Neostigmine are commonly administered to accelerate recovery of neuro muscular function, unfortunately these drugs will not provide fast restoration of neuro muscular function. Although neuromuscular blocking drugs are used extensively for facilitating surgical procedures and tracheal intubation during anaesthesia, concerns have been raised about the risks of post operative residual neuromuscular blockade, which may be associated with airway obstruction, pulmonary complications, hypoxia and increased mortality. Acetylcholine esterase inhibitor as Neostigmine is used for the reversal of non-depolarizing neuro muscular blockade ,but they carry risk of unwanted effects such as bradycardia, hypotension, bronchoconstriction, hypersalivation and nausea and vomiting. Anticholinergic drugs like atropine and glycopyrrolate are therefore co administered to counteract these adverse effects, but they may have their own side effects like tachycardia, blurred vision, sedation and mild confusion Rapid and complete reversal of neuromuscular blockade at the end of surgery is mandatory. Reducing residual neuromuscular block further decreases post op pulmonary complications. Choline esterase inhibitors are ineffective in reversing deep neuromuscular block and less effective when administered with inhalational anesthetics.  Post operative nausea and vomiting is one of the most common complication after general anesthesia that may cause increased morbidity and prolonged hospital stay Risk factors for PONV include: • Duration of anesthesia • Type of surgery • Post op analgesia with opioids • Patient related factors like age,gender,smoking • Previous history of PONV and motion sickness. Peak expiratory flow rate is surrogate marker for respiratory function.  The use of neuromuscular drugs is frequently associated with post op residual neuromuscular blockade ,and increased post operative morbidity and mortality and greater frequency of critical respiratory events and prolonged hospital stay6 Because of these reasons there is need for better reversal drugs with improved side effect profile and number of studies that are conducted to compare efficacy of Sugammadex and Neostigmine are nominal ,hence we are planning to conduct this study in our institution

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patient between 18-65 years of age.
  • Patient belonging to ASA physical status I-â…¢.

排除标准

  • Anticipation of a difficult airway Known or suspected neuromuscular disorders, Significant renal dysfunction Known or suspected family history of malignant hyperthermia Allergies to narcotics, muscle relaxants.

结局指标

主要结局

Sugammadex provides significantly Faster Reversal Of Vecuronium Induced Neuromuscular Blockade

时间窗: 1 minutes

次要结局

  • 1.Sugammadex Provides better recovery of respiratory function following reversal of neuromuscular blockade of general anesthesia(2.Sugammadex as lower incidence of post op nausea and vomiting.)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Chhaya Joshi

Professor

研究点 (1)

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