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临床试验/CTRI/2025/01/079632
CTRI/2025/01/079632尚未招募4 期

Comparison of Preoperative Nebulization of Dexmedetomidine Versus Lignocaine in Attenuating Hemodynamic Response to Direct Laryngoscopy and Endotracheal Intubation in Patients Undergoing Elective Laparoscopic Surgeries: A Randomized Double Blinded Clinical Study

BGS Global Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
To evaluate the effects of preoperative nebulized Dexmedetomidine (1mcg per kg) and Nebulized Lignocaine 4% (3mg per kg) on the hemodynamic response to laryngoscopy and intubation by monitoring vitals

研究概览

简要总结

**Direct laryngoscopy and tracheal intubation following induction of anaesthesia are associated with hemodynamic changes due to increased sympathoadrenal activity which may result in hypertension and tachycardia.****Multiple drugs have been used to blunt the hemodynamic response during endotracheal intubation one of them is Dexmedetomidine which is a highly selective alpha 2 agonist which has sympatholytic, sedative analgesic and amnestic properties.****Another drug is Lignocaine which is an amide local anaesthetic which reduces the excitation of airway sensory fibres.**Thus, in this study we compare the effects of pre-operative nebulization of Dexmedetomidine 1mcg/kg and 4% Lignocaine 3mg/kg on the haemodynamic response during endotracheal intubation in Patients Undergoing Elective laparoscopic surgeries.

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 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients willing to give informed written consent
  • American Society of Anaesthesiologists class I and II 3.Patients with normal airway on examination 4.Patients undergoing elective laparoscopic surgeries under general anaesthesia with endotracheal intubation with a duration of 2 to 4 hours are included in the study.

排除标准

  • 1.Individuals with BMI more than 30 kg per meter square 2.Mallampati grading more than 2 3.Anticipated difficult intubation requiring more than 15 seconds for intubation or more than two attempts at laryngoscopy 4.Patients with allergy to Dexmedetomidine and Lignocaine 5.Taking medicines such as Beta blockers, Clonidine, Gabapentin, Pregabalin, Anti-convulsant, Anti-psychotics
  • Pregnant patients are excluded from the study.

结局指标

主要结局

To evaluate the effects of preoperative nebulized Dexmedetomidine (1mcg per kg) and Nebulized Lignocaine 4% (3mg per kg) on the hemodynamic response to laryngoscopy and intubation by monitoring vitals

时间窗: Post Intubation at 1min, 3min, 5min, 10min, 15min, 30min, 45min, 60min, 90min, 120min, 150min, 180min, 210min and 240min.

次要结局

  • Amount of Inj Fentanyl consumed intra-operatively(Post Intubation at 1min, 3min, 5min, 10min, 15min, 30min, 45min, 60min, 90min, 120min, 150min, 180min, 210min and 240min.)

研究者

发起方
BGS Global Institute of Medical Sciences
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Harshith P Gowda

BGS Global Institute of Medical Sciences

研究点 (1)

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