Effect of oral melatonin as premedication on haemodynamic changes during laparoscopic cholecystectomy - A randomized double blinded controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To evaluate the effect of oral melatonin on hemodynamic parameters which include heart rate, mean arterial pressure, systolic and diastolic blood pressure during intra-operative and post-operative up to 24 hours after surgery, in patients undergoing laparoscopic cholecystectomy under general anesthesia
研究概览
简要总结
The following trail is a double blinded randomized control trail, which will compare the effect of oral melatonin given as premediction before surgery , the comparison with will be. control group which will receive multivitamin doses, the haemodynamic parameters will studied intraoperatively and post-operatively, and sedation, pain and VAS will be studied post recovery. the trail has been approved by institutional ethics committee.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •20-60 years old ASA category I and II BMI more than 18.5 and BMI less than 29.9 Patients undergoing elective cholecystectomy.
排除标准
- •Patients diagnosed with diabetes, hypertension, obesity, valvular heart disease, renal and hepatic impairment.
- •Patients on anticoagulants and antiplatelets.
- •Patients on other sedative hypnotic drugs.
- •Patients on antipsychotics, anxiolytics and antiepileptic.
- •Patients with sleep disorders.
- •Patients with known drug allergy.
- •Patients on oral contraceptives, caffeine, fluvoxamine, oral hypoglycemic agents, immunosuppressants.
- •Patients on calcium channel blockers.
- •Patients with anticipated difficult airway.
- •Pregnant patients.
- •Contraindication to general anesthesia.
- •Patients anticipated to have surgical complications.
结局指标
主要结局
To evaluate the effect of oral melatonin on hemodynamic parameters which include heart rate, mean arterial pressure, systolic and diastolic blood pressure during intra-operative and post-operative up to 24 hours after surgery, in patients undergoing laparoscopic cholecystectomy under general anesthesia
时间窗: 5 mins after intubation, 10 mins after intubation, before pneumoperitoneum, 5 mins after pneumoperitoneum till 30 mins after pneumoperitoneum and then after every 10 mins till patient is extubated. 1hr, 4hr, 8hr, 12hr,24hr, 36hr,48hr
次要结局
- To evaluate the effect of oral melatonin on post-operative sedation score, visual analogue score for post operative pain and rescue analgesics received postoperatively up to 24 hours after surgery.(1hour, 4hour, 8 hour, 12hour,24hour, 36 hour, 48 hour)
研究者
Dr. Deepanshu Dhiman
Dr. Yashwant Singh parmar Government medical college and hospital , Nahan