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临床试验/CTRI/2023/12/060488
CTRI/2023/12/060488尚未招募不适用

A comparative analysis of the effect of single dose esmolol and lidocaine on Middle cerebral artery velocity(MCA) during emergence from anaesthesia

Department of Anaesthesiology and Critical Care Jawaharlal Nehru Medical college AMU Aligarh1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年12月30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
90
试验地点
1
主要终点
Effect of esmolol and lidocaine on Middle cerebral artery velocity during emergence from anaesthesia

研究概览

简要总结

Tracheal intubation and extubation are critical steps during anaesthetic care where cardiovascular and respiratory decompensation can occur such as tachycardia, hypertension, arrythmias, myocardial ischaemia, bradycardia or laryngospasm.

These potentially fatal complications related to extubation result from stimulation of the larynx, trachea and bronchi which increase the release of catecholamine concentration.

Cerebral hyperaemia occur during extubation which is demonstrated by concomitant increase in cerebral blood flow velocity(CBFV).

A possible mechanism of hyperaemia and increasd CBFV is the sympathetic stimulation associated with emergence.

Pharmacological strategies such as local anaesthesia, N-Methyl - D -aspartate(NMDA) antagonist , alpha -2- agonist and beta- blocker can significantly blunt the sympathetic overactivity and reduce the rate of serious outcome relate to emergence.

We hypothesize that blunting the sympathetic overactivity will decrease CBFV and cerebral hyperaemia at emergence from anaesthesia

Therefore, we planned this prospective, randomised, double blind, placebo controlled study to comparatively analyse the effect of single dose esmolol and lidocaine on MCA velocity during emergence from anaesthesia.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator 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

  • Physical status of ASA I & II 2) Mallampati score class I & II.

排除标准

  • Physical status of ASA III & IV 2) Those with significant systemic disorder 3) Those with uncontrolled hypertension and cerebrovascular disease 4) Those with co-morbid disease 5) Allergy to local anaesthetic and those on beta- blocker therapy Pregnant female.

结局指标

主要结局

Effect of esmolol and lidocaine on Middle cerebral artery velocity during emergence from anaesthesia

时间窗: 1) T0- During anaesthesia | 2) T1- before administration of drugs (when train of four response is more than 90%) | 3) T2- After two minute of administration of drug | 4) T3- After three minutes of extubation

次要结局

  • 1. To analyse and compare the effect of esmolol and lidocaine on hemodynamic parameters e.g systolic blood pressure(SBP), heart rate(HR) during emergence from anaesthesia(2. To correlate the change in hemodynamic parameters (SBP, HR) with MCA velocity during emergence from anaesthesia)

研究者

发起方
Department of Anaesthesiology and Critical Care Jawaharlal Nehru Medical college AMU Aligarh
申办方类型
Government medical college

研究点 (1)

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