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临床试验/CTRI/2024/12/078705
CTRI/2024/12/078705尚未招募3 期

Comparison of effect of airway nebulization with lignocaine and dexmedetomidine on hemodynamic stress response to laryngoscopy and intubation in patients undergoing elective surgery under general endotracheal anaesthesia – A prospective randomized double blind study

Sri Venkateswara Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年1月10日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
70
试验地点
1
主要终点
To study and compare the hemodynamic stress response Heart rate(HR), systolic blood pressure(SBP), diastolic blood pressure (DBP)and mean arterial pressure(MAP) to laryngoscopy and intubation between 4% lignocaine group and Dexmedetomidine group

研究概览

简要总结

Dexmedetomidine, a selective alpha2-adrenoceptor agonist, is short-acting and has sedative, hypnotic, anxiolytic, analgesic, anti-sialagogue, sympatholytic properties and promotes cardiac, respiratory and neurological stability

Lignocaine is an amino- ethylamide and prototype of amide local anesthetic group. It is the most widely used local anesthetic. Showed that its intravenous use blunted pressure response to intubation. Lignocaine is also used in various routes of administration. Lignocaine is also given in nebulization route. Both these drugs are known to decrease the hemodynamic stress response to intubation.

The present study is undertaken to study and compare the efficacy lignocaine 4% (3mg/kg) and dexmedetomidine (1mcg/kg) nebulization to attenuate the hemodynamic stress response in patients undergoing elective surgeries under general anesthesia

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 68.00 Year(s)(—)
性别
All

入选标准

  • patient aged 18 to 65 years American society of anaesthesiologist status I and II patient scheduled to undergo surgery of less than 3 hours who require endotracheal intubation.

排除标准

  • 1.Patients not willing to give consent.
  • 2.BMI greater than 30 kg/m2 3.Pregnant and lactating women 4.Patients with known allergy to study drugs.
  • 5.Patients with uncontrolled systemic diseases 6.Anticipated difficult intubation 7.Laryngoscopy more than 20 seconds and more than 1 attempt at intubation are excluded retrospectively 8.Patients having a history of preoperative sore throat or recent upper respiratory tract infection.

结局指标

主要结局

To study and compare the hemodynamic stress response Heart rate(HR), systolic blood pressure(SBP), diastolic blood pressure (DBP)and mean arterial pressure(MAP) to laryngoscopy and intubation between 4% lignocaine group and Dexmedetomidine group

时间窗: at baseline (T0), after induction(T1), immediately after intubation(T2), at 1 min(T3), 2 min(T4), 3min(T5) and 5min(T6) after intubation.

次要结局

  • 1.To study the incidence of post operative sedation score using Ramsay sedation score (RSS).(2.To study the incidence of post operative sore throat or cough at 0, 6, 12, 24 hrs after tracheal extubation)

研究者

申办方类型
Other [nil]
责任方
Principal Investigator
主要研究者

Dr Jaisakthivel K S

Sri venkateswara institute of medical sciences

研究点 (1)

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