Effects of Oral Melatonin Premedication on Attenuation of Haemodynamic Response to Intubation and Anaesthetic Requirements in Geriatric Patients: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- compare the effect of oral melatonin premedication versus placebo on changes in Systolic Blood Pressure following intubation.
研究概览
简要总结
We aim to evaluate the effects of oral melatonin (6 mg) on hemodynamic responses to intubation and anesthetic requirements in geriatric patients undergoing laparoscopic cholecystectomy.
Background & Rationale:
Intubation triggers sympathetic activation, leading to increased heart rate and blood pressure, which can be harmful to elderly patients with cardiovascular conditions.
Commonly used drugs (opioids, beta-blockers, benzodiazepines) can cause adverse effects like hypotension, respiratory depression, and bradycardia.
Melatonin, a naturally occurring hormone, has sedative, anxiolytic, and hemodynamic stabilizing properties with minimal side effects.
The hemodynamic responses are noted at various times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 65.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •This prospective, randomized, double-blind study will be conducted on 70 patients undergoing laparoscopic cholecystectomy under general anaesthesia.
排除标准
- •1.Patient not consenting 2.Known or anticipated difficult airway 3.Morbid Obesity 4.History of mental illness 5.Known Allergy to the study drug 6.History of GERD 7.Patient on Antipsychotic, Sedatives, Anxiolytics, Antiepileptics 8.Patient having History of Sleep Disorders.
结局指标
主要结局
compare the effect of oral melatonin premedication versus placebo on changes in Systolic Blood Pressure following intubation.
时间窗: Baseline in Operation theatre, After induction, before intubation, after intubation, 1 minute post intubation, 3 minute post intubation, 5 minute post intubation, 10 minute post intubation, creation of pneumoperitneum
次要结局
- 1)To compare the effects of oral melatonin premedication on changes in Diastolic Blood Pressure, Mean Arterial Pressure and heart rate following intubation between the groups.
研究者
Ria Tyagi
Hamdard Institute of Medical Sciences and Research