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临床试验/CTRI/2025/02/081425
CTRI/2025/02/081425尚未招募4 期

Effect of Oral Melatonin, Oral Clonidine and Oral Pregabalin Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation

Sardar Patel Medical College Bikaner1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年11月3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
75
试验地点
1
主要终点
To Compare Effect of Oral Melatonin, Oral Clonidine and Oral Pregabalin Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation.

研究概览

简要总结

Laryngoscopy and endotracheal intubation are essential procedures required in elective case as well as emergency resuscitative settings. It is required to secure patients airway as well as to provide oxygenation and ventilation. Despite being a critical part of anaesthesia, it is still not free from hazard. These two are considered as noxious stimuli. Laryngoscopy alone generates same pressor response as can be seen by laryngoscopy followed by intubation. Hemodynamic stress response from airway instrumentation are due to sympathetic adrenergic response caused by epi pharyngeal and para pharyngeal stimulation leading to significant rise in the catecholamine level. This leads to various responses in various physiological systems of the body such as tachycardia, hypertension, arrhythmia, bronchospasm, increased intracranial pressure, elevation in intraocular pressure, etc. These hemodynamic changes usually peak at 1 to 2 min following laryngoscopy and tracheal intubation, and persist for 5–10 mins. Various methods to attenuate sympathetic response to laryngoscopy and tracheal intubation are being used and research for better drug is going on. All the above mentioned drugs have shown beneficial effects of blunting hemodynamic responses to laryngoscopy and tracheal intubation.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
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

  • Elective surgery under general endotracheal anesthesia.

排除标准

  • Anticipated difficult intubation.
  • Modified Mallampati grade III/IV.
  • Patient’s refusal to participate in the study.
  • Patient receiving treatment with either of the study drug i.e., Melatonin or Clonidine; or having any known allergy to these drugs.
  • Patients receiving treatment for any cardiac illness, pregnancy, renal disease, liver disease, morbid obesity, bleeding disorder, thyroid disorder, etc.
  • Patients on anti-hypertensives, oral hypoglycemic, anti-depressants, anti-convulsant, anti-psychotics, thyroid medications, and birth control pills.
  • Pregnant and lactating females.
  • Patients with prolonged laryngoscopy time (more than 30 s).

结局指标

主要结局

To Compare Effect of Oral Melatonin, Oral Clonidine and Oral Pregabalin Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation.

时间窗: At baseline

Hemodynamic changes like HR, SBP, DBP and MBP

时间窗: At baseline

次要结局

  • Requirement of intraoperative rescue Propofol doses and need for antihypertensive drug.

研究者

发起方
Sardar Patel Medical College Bikaner
申办方类型
Government medical college

研究点 (1)

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