Comparison of Sugammadex versus Neostigmine for the reversal of Rocuronium induced neuromuscular blockade under general anaesthesia:A randomised controlled study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the time taken for neuromuscular recovery between Sugammadex reversal and Neostigmine reversal for Rocuronium induced neuromuscular blockade as indicated by TOF monitoring
研究概览
简要总结
- General Anaesthesia relies on neuromuscular blockade to improve airway management and surgical conditions. However, residual neuromuscular blockade has been linked to an increased risk of pulmonary complications after surgery. The introduction of quantitative neuromuscular monitoring devices in the 1970s rendered subjective clinical parameters for monitoring neuromuscular blockade nearly become obsolete.
2)Deep neuromuscular blockade can enhance surgical conditions during major abdominal procedures and reduce insufflation pressures in laparoscopic surgeries. However, it is important to note that deep neuromuscular blockade has been associated with potential complications such as prolonged postoperative muscle paralysis, residual neuromuscular blockade, hypoxemia, and atelectasis.
3)Non-depolarizing neuromuscular blockers like Rocuronium are frequently used to relax muscles during surgery and to aid ventilate the lungs in emergency and elective cases. It is one of the several non-depolarizing neuromuscular blockers that are employed, but it stands out for being reversible and fast-acting.
4)Traditionally, acetylcholinesterase inhibitors were commonly used to reverse the effects of nondepolarizing neuromuscular blocking agents. However, these inhibitors were not effective enough in reversing deep blockade and can cause residual neuromuscular blockade with some undesirable effects. A new reversal agent called Sugammadex has been developed, which works by encapsulating and reversing the effects of Rocuronium. This study is planned to assess the efficacy and safety of Sugammadex to reverse the effect of Rocuronium induced neuromuscular blockade in comparison with standard Neostigmine reversal for the same.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient willing to participate with written informed consent.
- •Patients belonging to ASA grade I and 2 of either sex.
- •Patient with age group between 18 to 70 years posted for elective surgeries under General Anaesthesia.
排除标准
- •Known allergy to any of study drugs 2)Pregnancy and Lactation 3)Patients with history of high dose steroid intake 4)Patients with known Cardiac disorders/Respiratory illnesses/Endocrine disorders 5)Patients with known history of Renal dysfunction/Hepatic dysfunction 6)Patients who are suspected to have Neuromuscular disorders.
结局指标
主要结局
To compare the time taken for neuromuscular recovery between Sugammadex reversal and Neostigmine reversal for Rocuronium induced neuromuscular blockade as indicated by TOF monitoring
时间窗: Time taken for the reversal till TOF ratio of 0.9 is achieved.
次要结局
- To study hemodynamic changes between two groups of patients.(Intraoperatively and After extubation patient was monitered for any hemodynamic variability)