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临床试验/CTRI/2024/10/075432
CTRI/2024/10/075432尚未招募Phase 3 4

Comparison of Ropivacaine with Lignocaine by Nebulization for hemodynamic stress response during Extubation in patients undergoing surgeries under General Anaesthesia

Dr Haramritpal Kaur1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月11日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To study effect of ropivacaine by nebulization on hemodynamic stress response during extubation in patients undergoing surgeries under general anaesthesia

研究概览

简要总结

Hemodynamic changes such as increase in Blood Pressure, Heart Rate during airway management is common and can be associated with severe cardiovascular and neurological complications in some patients. Intravenous Lignocaine is commonly used to attenuate this response. Nebulization with local anaesthetics is also an alternative.

The techniques to suppress hemodynamic stress response include topical anaesthesia of oropharynx (viscous lignocaine) laryngotracheal instillation of lignocaine just prior to intubation, intravenous lignocaine, adrenergic blocking drugs (either alpha or beta blockers), vasodilators like hydrallazine, sodium nitroprusside, nitroglycerine, deep inhalational anaesthesia, intravenous opioids etc. However, no single agent has been established as the most appropriate for this purpose

In present study, we propose to evaluate and compare two local anaesthetic nebulization that is Lignocaine (2%) and Ropivacaine (0.75%) for their effect on extubation stress response. We hypothesized that Ropivacaine being longer acting should be able to suppress the extubation response better than Lignocaine.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • Mallampati grade I and II American Society of Anaesthesiologist grade I and II.

排除标准

  • Patients with a history of allergy to local anaesthetics/study drugs Patients in whom intubation time exceeded 15 seconds or in those where second attempt for intubation was needed Surgery duration more than 3 hrs.

结局指标

主要结局

To study effect of ropivacaine by nebulization on hemodynamic stress response during extubation in patients undergoing surgeries under general anaesthesia

时间窗: Till 15 mins of extubation

To study effect of lignocaine by nebulization on hemodynamic stress response during extubation in patients undergoing surgeries under general anaesthesia

时间窗: Till 15 mins of extubation

次要结局

  • To compare the effects of ropivacaine and lignocaine by nebulization on hemodynamic stress response during extubation in patients undergoing surgeries under general anaesthesia(Till 15 mins of extubation)
  • To compare the effects of ropivacaine and lignocaine by nebulization on postoperative sore throat in patients undergoing surgeries under general anaesthesia(Till 24 hours postoperative)
  • To compare the effects of ropivacaine and lignocaine by nebulization on postoperative cough in patients undergoing surgeries under general anaesthesia(Till 24 hours postoperative)

研究者

发起方
Dr Haramritpal Kaur
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Haramritpal Kaur

GGSMCH, Faridkot

研究点 (1)

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