Comparative study of Melatonin versus Pregabalin in attenuation of Hemodynamic stress response to Laryngoscopy and Endotracheal intubation in Patients undergoing Laparoscopic Cholecystectomy - A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Reducing stress response during Endotracheal intubation
研究概览
简要总结
Laryngoscopy and intubation are painful stimuli which invoke responses like tachycardia, hypertension and arrythmias. The hemodynamic stress response resulting from airway instrumentation are due to sympatho-adrenergic response caused by epi-pharyngeal and parapharyngeal stimulations which lead to rise in catecholamine level that increases blood pressure and heart rate.
These Hemodynamic responses may be fatal in patients with coronary artery disease, hypertension, intracranial aneurysm, cerebrovascular disease and may cause MI, arrythmias, left ventricle failure and rupture of aneurysm.
MELATONIN (N-acetyl-5-methoxytryptamine) is a endogenous sleep regulating hormone secreted by pineal gland. Exogenous administration of melatonin facilitates sleep and improves quality of sleep. It is different from benzodiazepines and their derivatives in that it produces natural sleep pattern and doesn’t lead impairment of cognitive functions. This drug has been mainly studied as sedative agent in intensive care unit and preoperatively as anxiolytic agent.
PREGABALIN a gabapentinoid compound appears to produce an inhibitory modulation of neuronal excitability particularly neocortex, amygdala, hippocampus of CNS. It binds to the a2d subunit of voltage dependent calcium channels and inhibits the channel. It possesses analgesic, anticonvulsant and anxiolytic activity by reduction of neurotransmitter glutamate, nor-adrenaline, serotonin, dopamine and substance P.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of American society of Anaesthesiologists (ASA) physical status Grade I, II and III.
排除标准
- •Patients with Psychiatric illness,Sleep disorders, Drug allergy, anticipated difficult airway are excluded.
结局指标
主要结局
Reducing stress response during Endotracheal intubation
时间窗: Blood pressure, Heart rate , Mean arterial Pressure, Sedation score are monitored before, at the time and after intubation till 15 minutes and one hour post extubation
次要结局
- Effect on Sedation(Pre operative & Post extubation sedation will be monitored using Ramsay sedation score)
研究者
DR Sukhirtha S
Narayana Health City
