Comparison of Neostigmine Vs. Sugammadex for recovery of muscle function after neuromuscular blockade by means of diaphragm ultrasonography in non-cardiac surgery: A randomised control trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- To compare the incidence of PORC defined by diaphragmatic thickening fraction ≤0.36 ,
研究概览
简要总结
| PORC (Postoperative residual curarisation) is a very common complication due to use of muscle relaxants with incidence ranging from 26% to 88% at various studies depending upon use of various definitions, criteria, study populations and type of muscle relaxants. |
PORC can cause Postoperative pulmonary complications (PPC), increase length of hospital stay in postanesthesia care unit (PACU), risk of reintubation, aspiration.
Accleromyography is a commonly used neuromuscular monitoring (NMT) used as a quantitative tool for assessment of PORC, but its distressing to the patients in awake state. Hence diaphragm ultrasonography can be used to assess the PORC by measuring diaphragm thickening fraction [PORC is defined as diaphragm thickening fraction less than or equal to 0.36.
Neostigmine a commonly used reversal agent has many adverse effects such as airway obstruction, bradycardia, hyper salivation, broncho constriction, upper airway obstruction, dysphagia, nausea, vomiting.
Sugammadex, a novel reversal agent, causes full and rapid recovery even from deep neuromuscular blockade. Studies have shown that it reduces the incidence of PORC.
Most of the studies are based on effect Sugammadex on reversal of neuromuscular blockade by Rocuronium but very few studies have been done on effect of Sugammadex on Vecuronium induced neuromuscular blockade.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor 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
- •1.Patients undergoing elective non-cardiac surgery 2.ASA grade I to III 3.AGE- 18- 70 Years.
排除标准
- •1.Emergency surgery 2.Refusal to treatment 3.Allergy to study drug 4.Renal and hepatic failure 5.Pregnant and nursing mother 6.Diaphragmatic palsy 7.Poor image quality.
结局指标
主要结局
To compare the incidence of PORC defined by diaphragmatic thickening fraction ≤0.36 ,
时间窗: We will measure the thickening fraction of diaphragm by ultrasonography at three readings. The baseline will be taken before induction, just before extubation, at 30 minutes after extubation in postop area. | All the outcomes will be assessed for 24 hours for taking the results into account.
between two groups after administration of Neostigmine or Sugammadex assessed by diaphragm USG
时间窗: We will measure the thickening fraction of diaphragm by ultrasonography at three readings. The baseline will be taken before induction, just before extubation, at 30 minutes after extubation in postop area. | All the outcomes will be assessed for 24 hours for taking the results into account.
次要结局
- To compare:(1)Time to achieve TOF ratio ≥ 0.9 or four twitches since administration of last dose of muscle relaxant (whichever is later))