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临床试验/CTRI/2025/04/085989
CTRI/2025/04/085989尚未招募4 期

Comparison between Nitroglycerine and Lignocaine spray for attenuation of pressor response during laryngoscopy and endotracheal intubation in patients undergoing elective surgery under general anaesthesia

Narayana Hrudayalaya hospital1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2025年10月5日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
78
试验地点
1
主要终点
To compare the systolic blood pressure variation between the two groups at baseline , at the time of intubation and till 15 mins post intubation.

研究概览

简要总结

Laryngoscopy and intubation are painful stimuli which leads to tachycardia , hypertension and arrhythmias. This hemodynamic stress response to airway instrumentation is due to the activation of sympatho-adrenergic response causing increase in the circulating catecholamines causing increase in heart rate and blood pressure .

While these changes are tolerated by a normal healthy patient ,these may be fatal in patients with coronary artery disease , Hypertension,  intracranial aneurysm , cerebrovascular disease and may cause MI , arrhythmias , left ventricular failure and rupture of aneurysm.

NITROGLYCERINE causes vascular smooth muscle dilatation through cGMP activated pathways leading to the desired vasodilatory effect.

LIGNOCAINE causes hypotension through two mechanisms- the first is the dose dependant negative inotropic action by blocking calcium influx in the heart. Second by blurting the airway reflexes.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor 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

  • Patients of American Society of Anesthesiologists (ASA) physical status grade I and II undergoing elective surgery under general anesthesia.

排除标准

  • Patient refusal ,patients with ischemic /Valvular heart disease , Renal and liver dysfunction and patients with known hypersensitivity to Lignocaine and Nitroglycerine are excluded.

结局指标

主要结局

To compare the systolic blood pressure variation between the two groups at baseline , at the time of intubation and till 15 mins post intubation.

时间窗: To compare the systolic blood pressure variation between the two groups at baseline , at the time of intubation and till 15 mins post intubation.

次要结局

  • To compare the heart rate , diastolic blood pressure & mean arterial pressure between the two groups at baseline , at the time of intubation andtill 15 mins post intubation.(To compare the heart rate , diastolic blood pressure & mean arterial pressure between the two groups at baseline , at the time of intubation & till 15 mins post intubation.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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