To compare safety and efficacy of 1mg/kg sugammadex combining with neostigmine 50µg/kg versus 2mg/kg sugammadex for reversal of vecuronium induced shallow neromuscular block in abdominal surgeries under general anaesthesia-A Randomised control study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- To compare time required for adeqaute reversal of neuromuscular blockade .
研究概览
简要总结
Elective abdominal surgeries are planned procedures, and can include procedures like appendectomy, cholecystectomy, hernia repair, and colorectal surgery, often performed laparoscopically for better recovery.
Laparoscopic surgery is now widely established. Benefits include reduced postoperative pain, improved cosmetic results and patient satisfaction, and reduced hospital stays. The range of surgical techniques is increasing in complexity and now includes cholecystectomy, adrenalectomy, nephrectomy, fundoplication, hernia repair, bowel resection and gynaeco logical procedures,where general anaesthesia is preferred.
Sugammadex is a new reversal agent that works differently than cholinesterase inhibitor neostigmine .It binds with high affinity to vecuronium and rocuronium in blood decreasing its plasma concentration and creating a gradient between the plasma and the neuromuscular junction, This process results in removing the non depolarizing agent from there receptors as it follows the concentration gradient towards the blood.
A dose of 4mg/kg and 2 mg/kg has been established for reversal of deep and shallow neuromuscular block induced by rocuronium and vecuronium.[4]However the high cost of this drug is prohibitive and is a significant limitation for its routine use in many institutions, especially when higher doses are required.Few studies have suggested that a dose of 0.22 mcg/kg Sugammadex and 34mcg/kg neostigmine accelerates recovery from TOF ratio of 0.5 to a ratio of at least 0.9 in an average of 2 min .
We hypothesize that the combination of neostigmine with half dose sugammadex (1mg/kg) would be non inferior to 2mg/kg recommended dose in reversing vecuronium induced shallow NMB.Given the high cost of Sugammadex this multimodal approach would be an effective cost reducing method ,while preserving the advantage of this novel agent .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
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 to 65yr
- •Patient willing to give informed consent.
- •Patients undergoing elective abdominal surgery under general aneasthesia.
排除标准
- •1 Age more than 65years 2 ASA 3 3 patients undergoing emergency surgery 4 patients having allergy to drugs.
结局指标
主要结局
To compare time required for adeqaute reversal of neuromuscular blockade .
时间窗: To compare time required for adeqaute reversal of neuromuscular blockade . | recovery of the patient observed every 20 seconds until 1 hour post surgery
recovery of the patient observed every 20 seconds for 1 hour post surgery
时间窗: To compare time required for adeqaute reversal of neuromuscular blockade . | recovery of the patient observed every 20 seconds until 1 hour post surgery
次要结局
- to know the side effects(observed until 1 hour post surgery)
研究者
Dr Yathish S K
Bangalore medical college and research institute Bangalore
