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临床试验/CTRI/2018/11/016361
CTRI/2018/11/016361已完成2 期

Comparison of efficacy of Atracurium versus Cisatracurium in patients undergoing surgeries under General Anaesthesia

DrAswani Baskaran1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年11月26日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Onset and duration of action of neuromuscular blocking drug

研究概览

简要总结

This study is a randomized  double blinded parallel group trial comparing the efficacy of atracurium and cisatracurium in patients undergoing surgeries under general anesthesia. The loading dose (2*ED95) of ATRACURIUM is 0.5mg/kg iv and maintenance dose of ATRACURIUM is 0.1mg/kg iv.The loading dose92*ED95) of Cistracurium is 0.1mg/kg iv and maintenance dose of CISATRACURIUM is 0.02mg/kg iv. The study is conducted for a period of one year in Chettinad Hospital and research Institute. The primary outcome of the study is onset and duration of action of the neuromuscular blocking drug. The secondary outcomes are the hemodynamic variability, histamine release and condition on intubation.

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

  • ASA I ASA II ASAIII Both elective and emergency procedures.

排除标准

  • ASAIV Pregnant patients Patients with Bronchial asthma Patients with history of cardiovascular disorders Patients with history of hepatic and renal disorders Patients on medications known to interact with neuromuscular blocking drugs.

结局指标

主要结局

Onset and duration of action of neuromuscular blocking drug

时间窗: Onset of action : time from the administration of drug till TOF0. Duration of action is time from administration of drug till TOF1

次要结局

  • Haemodynamic variability ( HR SBP DBP SPO2 ) Histamine release laryngoscopy(10min 20min 30min 45min 60min 75min 90min 105min 120min)

研究者

发起方
DrAswani Baskaran
申办方类型
Other [self]

研究点 (1)

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