Evaluation of haemodynamic and pharmacodynamic effects of cisatracurium and vecuronium in participants undergoing laproscopic appendicectomy:A prospective randomized parallel group double blind clinical trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1)Time of onset of action
研究概览
简要总结
Neuromuscular blocking agents (NBM’S) both depolarizing and non depolarizing are routinely used to facilitate tracheal intubation during induction of anaesthesia and to maintain satisfactory muscle relaxation during surgery.
Atracurium, a non depolarizing muscle relexant with an intermediate duration of action is independent of hepatic and renal functions to terminate its action and had minimal side effects but it also shows weak histamine releasing properties which contribute to many of its cardiovascular side effects.
Thus newer agent cis-atracurium has no histamine releasing properties, greater haemodynemic stability, hoffmann degradation so elimination of drug is independent of hepatic and renal failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed written consent 2)18 to 50 years of age 3)Patient is of either gender 4)ASA physical status I and II 5)Undergoing elective laproscopic appendicectomy 6)Requiring endotracheal intubation.
排除标准
- •Refusing to give consent 2)Anticipated difficult airway 3)Pre existing liver or renal failure 4)Therapy with drug known to interfere with neuromuscular transmission 5)Antenatal and lactating females 6)Prolonged preoperative bed rest 7)Patient having neuromuscular disorders 8)ASA physical status III and IV.
结局指标
主要结局
1)Time of onset of action
时间窗: 1)Noted when TOF count is reduced to 3 on PNS afer giving loading dose | 2)Noted when no response to TOF on PNS after giving loading dose | 3)Noted when TOF count is more than 2 on PNS after giving loading dose | 4)Noted when TOF count is more than 2 on PNS after giving top up dose of drug | 5)Noted from end of the operation to extubation and TOF count is 4 on PNS
2)Intubation time
时间窗: 1)Noted when TOF count is reduced to 3 on PNS afer giving loading dose | 2)Noted when no response to TOF on PNS after giving loading dose | 3)Noted when TOF count is more than 2 on PNS after giving loading dose | 4)Noted when TOF count is more than 2 on PNS after giving top up dose of drug | 5)Noted from end of the operation to extubation and TOF count is 4 on PNS
3)Time interval between loading and first maintenance dose
时间窗: 1)Noted when TOF count is reduced to 3 on PNS afer giving loading dose | 2)Noted when no response to TOF on PNS after giving loading dose | 3)Noted when TOF count is more than 2 on PNS after giving loading dose | 4)Noted when TOF count is more than 2 on PNS after giving top up dose of drug | 5)Noted from end of the operation to extubation and TOF count is 4 on PNS
4)Time interval between maintenance doses
时间窗: 1)Noted when TOF count is reduced to 3 on PNS afer giving loading dose | 2)Noted when no response to TOF on PNS after giving loading dose | 3)Noted when TOF count is more than 2 on PNS after giving loading dose | 4)Noted when TOF count is more than 2 on PNS after giving top up dose of drug | 5)Noted from end of the operation to extubation and TOF count is 4 on PNS
5)Extubation time
时间窗: 1)Noted when TOF count is reduced to 3 on PNS afer giving loading dose | 2)Noted when no response to TOF on PNS after giving loading dose | 3)Noted when TOF count is more than 2 on PNS after giving loading dose | 4)Noted when TOF count is more than 2 on PNS after giving top up dose of drug | 5)Noted from end of the operation to extubation and TOF count is 4 on PNS
6)Total number of doses required
时间窗: 1)Noted when TOF count is reduced to 3 on PNS afer giving loading dose | 2)Noted when no response to TOF on PNS after giving loading dose | 3)Noted when TOF count is more than 2 on PNS after giving loading dose | 4)Noted when TOF count is more than 2 on PNS after giving top up dose of drug | 5)Noted from end of the operation to extubation and TOF count is 4 on PNS
次要结局
- Haemodynamic effects( pulse, non invasive blood pressure monitoring)(Baseline)