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临床试验/CTRI/2019/08/020647
CTRI/2019/08/020647尚未招募不适用

Cis-atracurium in different doses vs Rocuronium in Laparoscopic Cholecystectomy Surgery under General Anaesthesia: Prospective, Comparative, Randomised Controlled study

Central Hospital Garden Reach South Eastern Railway1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年11月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
1.To compare Onset time of the Muscle Relaxant among 3 groups.

研究概览

简要总结

cis-atracurium is non-depolarising neuromuscular blocking agents with advantages like being metabolised by Hoffmann elimination and  as a most potent molecule it produces less laudanosine, dose not release histamine in clinical dose ranges .And it is noticed that even  after large doses there is no cardiovascular changes . Inspite of these advantages it is of limited use because of slow onset and unsatisfactory intubating condition compared with equipotent doses of other neuromuscular blocking agents like Rocuronium. But we could not use rocuronium in hepatic and renal compromised patients because it mostly metabolised in liver . In this study we will investigate wheather Cis-atracurium with increasing doses can be near ideal  neuromuscular blocking agents in comparison to rocuronium in producing acceptable intubating condition with relatively safe and short  duration  of muscle paralysis. Assuming p value <0.05 to be significant and considering effect to be two sided, we get Za =1.96; assuming power of the study to be 90% we get Z1- b = 1.28 ; considering an effect size of 95 to be statistically significant we get n =25 in each group. Hence minimum 25 patients will be taken in each group.  

After obtaining approval fro institutional ethical committe & informed written consent will be taken from 25 patients of each group under going general anaesthesia and endotracheal intubation for Laparoscopic Cholecystectomy surgery .All the patients will be put on IV canula & standard monitors (Skanray) including NIBP,ECG,Pulse Oxymetry . Before induction of anaesthesia TOF Scan NMT Monitor probe will be placed on the thumb & monitor will be swiched on. All the patients will receive premedication inj. Fentanyl 2mcg/kg just before induction of anaesthesia. After preoxygenation with 100% oxygen, patient  will be induced with 2mg/kg IV Propofol over 30 sec.After loss of consiousness to facilitate tracheal intubation,neuromuscular blocking agents will be infused either with a single bolus dose of Cisatracurium or Rocuronium . The calculated amount of muscle relaxant will be injected over 5 sec into a rapid infusion of normal saline .Following maximal depression of T1  (onset time) , direct laryngoscopy will be initiated followed by tracheal intubation .The ulner nerve will be stimulated at the wrist with a square wave stimulus set at a current of  50 mA and duration of 0.2 ms each will be delivered in a  train-of-four (TOF) sequence,repeated every 12 sec using TOF Scan NMT Monitor. After intubation ,anaesthesia will be maintained by 65% nitrous oxide and 3.0 volume % Desflurane (inspired) .

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 60.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anaesthesiologist Physical Status(ASA-PS) I & II
  • Age group 18 --- 60 yrs.
  • Laparoscopic Cholecystectomy surgery under general anaesthesia & Endotracheal intubation with minimum one hour surgery duration (1.00 hrs).

排除标准

  • a.ASA class III or IV b.Patients with anticipated difficult intubation (Mallampati score III and more), c.BMI ≥ 30 d.Patient with diseases affecting neuromuscular transmission (myopathies).
  • e.Patients with severe Cardiovascular, respiratory , renal diseases f.
  • Patients on drug & alcohol abuses.
  • g.Gastroesophageal refiux or hiatus hernia.
  • h.Patients posted for emergency surgery.
  • i.H/o allergy to drugs frequently used in anaesthesia j.Patients receiving medication known to interfere with NMBs (anticonvulsants, amino glycosides or polypeptide antibiotics.

结局指标

主要结局

1.To compare Onset time of the Muscle Relaxant among 3 groups.

时间窗: August 2019 to February 2020 i.e. 6 month

Comparison of two different doses of cis-atracurium i.e. (3×ED 95) 0.15 mg/kg &amp; (4×ED 95) 0.20 mg/kg vs Rocuronium(3×ED 95) 0.90 mg/kg in (Total 3 groups i.e. CIS 1,CIS 2,ROC)

时间窗: August 2019 to February 2020 i.e. 6 month

2.To compare Time to intubation among 3 groups .

时间窗: August 2019 to February 2020 i.e. 6 month

3. To compare Intubating condition among 3 groups .

时间窗: August 2019 to February 2020 i.e. 6 month

4. To compare Clinical duration of the Intubating 1st dose or DUR 25 among 3 groups.

时间窗: August 2019 to February 2020 i.e. 6 month

次要结局

  • 1.Haemodynamic changes ( Mean Arterial Pressure, Heart Rate) among the three groups.(2.Any Adverse reaction to drugs (itching, pruritus, anaphylaxis) among the groups .)

研究者

发起方
Central Hospital Garden Reach South Eastern Railway
申办方类型
Research institution and hospital

研究点 (1)

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