Evaluation of efficacy of neostigmine vs sugammadex for reversal of vecuronium induced neuromuscular blockage in patients scheduled for elective surgeries under general anaesthesia: Prospective, double blind randomized controlled study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To compare recovery time from vecuronium-induced neuromuscular blockage in both the groups.
研究概览
简要总结
Evaluation of efficacy of neostigmine vs sugammadex for reversal of vecuronium induced neuromuscular blockage in patients scheduled for elective surgeries under general anaesthesia: Prospective double blind randomized controlled study.
•At the end of the surgery, reversal of the action of neuromuscular blockage drugs(NMBDS) is preformed to accelerate recovery from neuromuscular blockade. At present Acetylcholinesterase inhibitors are used to reverse the action of NMBDs which have unwanted muscarinic side effects, such as bradycardia, hypotension, bronchoconstriction, hypersalivation and nausea-vomiting. To overcome these muscarinic side effect, anticholinergic drugs like glycopyrrolate is used which has its own side effects, like tachycardia, blurred vision, sedation and possible mild confusion. [1]
•Sugammadex, a novel drug, developed which was launched in 2021 in India, has unique property to reverse neuromuscular blockage induced by NMBDs. It encapsulate unbound NMBDs and reducing the free NMBD fraction at the neuromuscular junction and that encapsulated molecule is excreted as unchanged form in urine. [1] [2]
•Study Design: Prospective, double blind randomized controlled study
•Study Setting(Site): Operation theatre Sir-T hospital Bhavnagar.
•Study Population: All patients from 18 to 60 years of age will be operated under general anaesthesia in Sir-T hospital Bhavnagar
•Study Duration : 15 months
•Duration of Data collection: 12 months
•Sample Size : Within one year after permission from EC, all the patients who will be eligible in inclusion criteria are included in this study.
•Sampling method : Convenient sampling
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age : 18-60 years ASA grade I-III.
- •Patient scheduled for a surgical procedure under general anaesthesia in a supine position requiring tracheal intubation.
排除标准
- •Difficult airway Known neuromuscular disorders Significant hepatic and/or renal disorders Known family history of malignant hyperthermia Allergies to drug Administration of any medication interfering with NMBDs Pregnant females or lactating mothers.
结局指标
主要结局
To compare recovery time from vecuronium-induced neuromuscular blockage in both the groups.
时间窗: 15 months
To compare the haemodynamic changes(Blood pressure, Pulse rate and SpO2) in both the groups.
时间窗: 15 months
次要结局
- To compare the side effect and complication, if any in both the groups.
研究者
Dr Swaraj Panchal
Sir-T Hospital Bhavnagar