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临床试验/CTRI/2018/03/012704
CTRI/2018/03/012704招募中不适用

Evaluation of neuromuscular blockade with Vecuronium during general anesthesia with Oxygen : Nitrous oxide, Isoflurane vs Oxygen : Air, Isoflurane.

Jawaharlal institute of postgraduate education and research1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年12月24日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
Using neuro muscular monitoring,To assess and compare neuromuscular blockade of vecuronium during general anaesthesia with O2,N2O and isoflurane versus O2,air and isoflurane.

研究概览

简要总结

Conventionally balancedanesthesia involves the use of inhalational agents and non depolarizingagents.  Isoflurane is added to nitrousoxide at 66% to act as carrier gas. However as nitrous oxide can causedistension of bowel due to its low solubility, the use of air with oxygen andisoflurane has become common particularly in abdominal and laparoscopicsurgeries. When nitrous oxide is replaced by air, the percentage of isofluraneis kept higher to ensure adequate depth of anesthesia. Inhalational agents havevariable effect on muscle relaxants and by themselves are also known to have aneffect on neuromuscular junction. Nitrous oxide also is known topotentiate neuromuscular blockers . With  varied mixture of gases and isoflurane usedin general anaesthesia ,the exact dosing requirement and time duration ofaction has not been precisely studied with vecuronium when given as bolus as isgiven routinely. Hence this study is undertaken to evaluate and compare  the neuromuscular effect of vecuronium  during anaesthesia with oxygen, nitrous oxide (O2:N2O)  and isoflurane and oxygen,air (O2:air) andisoflurane.

Quantifyingthe character of the block by neuromuscular monitoring by measuring singletwitch, post tetanic count (PTC), and train of four (TOF) can give precision ofthe block and thereby better titration of drugs.

Researchhypothesis (es)****:

The characterof  neuromuscular block with vecuronium will be same with nitrous oxide and without nitrous oxide,when  used with isoflurane.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adult patients undergoing elective surgical procedures of more than one hour duration, requiring general anesthesia with muscle relaxation.

排除标准

  • Patient’s refusal.
  • Patients with hepatic or renal dysfunction.
  • Patients with neuromuscular disorders.
  • Patients on medication that may alter neuromuscular transmission.
  • 5.Pregnant patients and patients above 65 years of age.
  • Contraindication to nitrous oxide, isoflurane or vecuronium.

结局指标

主要结局

Using neuro muscular monitoring,To assess and compare neuromuscular blockade of vecuronium during general anaesthesia with O2,N2O and isoflurane versus O2,air and isoflurane.

时间窗: PTC1-TOF1

次要结局

  • Using neuro muscular monitoring,To assess and compare 1. block onset time of vecuronium in both the groups using the time taken for twitch height depression to become 30% of normal(2. from vecuronium administration to first appearance of PTC 1)

研究者

发起方
Jawaharlal institute of postgraduate education and research
申办方类型
Research institution and hospital

研究点 (1)

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