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临床试验/CTRI/2017/10/010254
CTRI/2017/10/010254已完成不适用

Comparison of effect of airway nebulisation with lignocaine 2% vs ropivacaine 0.25% on intubation and extubation response in patients undergoing surgery under general anaesthesia, A Randomised double blind clinical trial

Dr Ramyavel1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年11月30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
60
试验地点
1
主要终点
Hemodynamic parameters ( Heart rate, Mearn arterial Pressure and saturation) at the time of intubation and extubation.

研究概览

简要总结

Both intubation and extubation is associated with hemodynamic changes . To reduce this response we aimed at using local anaesthetics i.e. ropivacaine 0.25% and lignocaine 2% topically .Both the drugs will be given via nebulisation prior to induction. After IEC approval 60 patients of age group 18 to 60 years belonging to ASA 1 and ASA 2 undergoing surgery under general anaesthesia will be enrolled in the double blind study.About 20 min before induction, patients will be given either of the drug via nebulisation. Anaesthesia induction and intubation  and extubation will be according to standard protocol. Hemodynamic parameters ie HR, MAP and spo2 will be recorded at various time points. Severity  of cough and time to extubation will also be recorded.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator 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 1 and ASA 2 Patients posted for surgery under general anaesthesia.

排除标准

  • duration of surgery >3 hours.
  • surgery involving the airway.
  • patients with history of respiratory disease or LRI.
  • >3 attempts at laryngoscopy or intubation.

结局指标

主要结局

Hemodynamic parameters ( Heart rate, Mearn arterial Pressure and saturation) at the time of intubation and extubation.

时间窗: MAP, HR, and Spo2 at; | A)Baseline (T1) | B)Upon tracheal intubation (T2) | C)Upon anaesthetic withdrawal (T3) | D)Upon eye opening on verbal commands (T4) | E)Upon tracheal extubation (T5) | F)2 min after extubation (T6)

次要结局

  • 1) severity of cough at extubation(2) time to extubation)

研究者

发起方
Dr Ramyavel
申办方类型
Other [primary investigator]

研究点 (1)

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