跳至主要内容
临床试验/CTRI/2024/03/064813
CTRI/2024/03/064813尚未招募不适用

Efficacy of three different doses of Fentanyl Citrate for attenuation of hemodynamic stress response to Laryngoscopy and Endotracheal Intubation in surgeries under General Anaesthesia - A Randomised Comparative Study.

ABVIMS and Dr Ram Manohar Lohia Hospital1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2024年4月3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
111
试验地点
1
主要终点
Hemodynamic parameters to Laryngoscopy and Endotracheal Intubation (HR, SBP, DBP, MAP).

研究概览

简要总结

Securing the airway is an essential component of anaesthesia care for patients undergoing surgeries under General Anaesthesia. Laryngoscopy and Endotracheal Intubation are core integral components of anaesthetic management under General Anaesthesia but these are associated with reflex cardiovascular responses mediated by sympathetic nervous system by stimulating sympathoadrenal receptors releasing catecholamines in the blood thus transiently causing tachycardia, hypertension, arrhythmias and raised intraocular and intracranial       pressures. Such pressor responses are well tolerated in healthy individuals but are hazardous in patients suffering from coronary artery disease, hypertension, valvular heart disease, stroke, intracranial lesions and penetrating eye injuries.

Several measures have been shown for attenuation of hemodynamic stress response to laryngoscopy and Endotracheal intubation including deepening the plane of anaesthesia, limiting the duration of Laryngoscopy for <30 seconds, various pharmacological measures such as Opioids like Fentanyl ,Vasodilators, Beta Blockers( selective and non selective), Calcium channel blockers, Lignocaine , Magnesium Sulphate etc. Among these, Fentanyl belongs to the phenylpiperidine group of synthetic opioids and is a opioid agonist at Âµ1 and Âµ 2 receptors with rapid onset of action peak of about 5 mins and rapid termination of its effects after a single dose and the occurrence of relative cardiovascular stability and has been shown to effectively attenuate hemodynamic stress response to Laryngoscopy and Endotracheal intubation. Fentanyl decreases the heart rate by increasing Vagal tone by stimulating Vagal nuclei in the medulla thereby, preventing hemodynamic stress response to Laryngoscopy and Endotracheal Intubation .

          It also dilates arterial and venous blood vessels through a central mechanism,by primarily slowing down vasomotor centers in the brain. Recent assays in man show no clinically significant histamine release in dosages up to 50mcg/kg. Total moderate dose of Fentanyl Citrate in adults for General anaesthesia is 2-20mcg/kg.

We devised this study to evaluate the efficacy of three different doses of Fentanyl Citrate for

attenuation of hemodynamic stress response to Laryngoscopy and Endotracheal Intubation.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • American Society Of Anaesthesiologists [ASA] physical status I and II patients.
  • Elective surgical procedure of more than 3 hours.

排除标准

  • 1.Known sensitivity to any study drug.
  • 2.Pregnant females.
  • 3.Patient with chronic Hypertension and Diabetes Mellitus.
  • 4.Patient with history of cardiac or respiratory disease.
  • 5.Patient with anticipated difficult airway.
  • 6.Patient with impaired kidney or liver function.

结局指标

主要结局

Hemodynamic parameters to Laryngoscopy and Endotracheal Intubation (HR, SBP, DBP, MAP).

时间窗: Hemodynamic parameters to Laryngoscopy and Endotracheal Intubation (HR, SBP, DBP, MAP) at 1 min, 3 min and 5 mins

次要结局

  • Biochemical markers of stress response ( SERUM CORTISOL AND BLOOD GLUCOSE LEVELS ).(Pre op and 5 mins after intubation)

研究者

发起方
ABVIMS and Dr Ram Manohar Lohia Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Dielle Jade Martins

ABVIMS and Dr Ram Manohar Lohia Hospital

研究点 (1)

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