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临床试验/CTRI/2021/09/036550
CTRI/2021/09/036550已完成不适用

Comparison of effects of cisatracurium and atracurium upon Tryptase, IgE levels and Absolute eosinophil counts in adult patients undergoing general anesthesia for elective surgery.

ABVlMS and Dr RML hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年6月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Patients tryptase levels,IgE levels, absolute eosinophil count, hemodynamic parameters (heart rate and SBP/DBP), cilinical side effects ( flushing of skin, rashes, hypotension, tachycardia, bronchospasm, anaphylaxis, arrhythmias)

研究概览

简要总结

This is a  randomized prospective observational study in which comparison will be done on effects of cisatracurium and atracurium upon trypase levels , Ig E levels and absolute eosinophil counts in adult patients undergoing general anesthesia for elective surgery in Dr RML hospital New Delhi . The outcome measures will be tryptase levels, IgE levels, absolute eosinophil count , hemodynamic parameters and clinical side effects profile of the patients before induction, one and two hours after giving first dose of study drug and at the time of any side effects if any.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Consenting adult patients with ASA Grade 1/2 and modified Mallampati grade 1/2.

排除标准

  • Patients with anticipated difficult airway.
  • Patients with peripheral neuropathy, diabetes mellitus, neuromuscular disorders and myopathies.
  • Patients on antibiotics (e.g., aminoglycosides, tetracyclins, bacitracin, lincomycin, clindamycin, colistin).
  • Patients on drugs like Magnesium sulphate, lithium, procainamide and quinidine.
  • Patients with history of atopy and asthma.
  • Patients with known allergy to any of the drugs involved in study.
  • pregnant patients.

结局指标

主要结局

Patients tryptase levels,IgE levels, absolute eosinophil count, hemodynamic parameters (heart rate and SBP/DBP), cilinical side effects ( flushing of skin, rashes, hypotension, tachycardia, bronchospasm, anaphylaxis, arrhythmias)

时间窗: Blood samples will be taken before induction , one and two hour after giving first dose of study drug and additional sample if and when any side effects occurs.

次要结局

未报告次要终点

研究者

发起方
ABVlMS and Dr RML hospital
申办方类型
Government medical college

研究点 (1)

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