A prospective randomized comparative study of ketamine versus tramadol pretreatment to reduce pain on injection of propofol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To evaluate and compare the incidence and severity of pain on propofol injection following intravenous pretreatment with ketamine versus tramadol.
研究概览
简要总结
This prospective, randomized, double-blind study will compare ketamine (0.2 mg/kg) and tramadol (0.5 mg/kg) pretreatment with placebo to reduce pain on propofol injection in 120 adult patients undergoing elective surgery. Pain will be assessed using a four-point verbal rating scale, and hemodynamic changes and side effects will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex, aged between 18-60 years.
- •Patients belonging to the American Society of Anesthesiologists Class I & II.
- •Patients posted for elective surgery under general anesthesia.
排除标准
- •Patient not willing to give consent.
- •Patients with a history of allergy or contraindication to either propofol, ketamine, or tramadol.
- •Patients with anticipated difficult cannulation.
- •difficulty in communication.
- •Neurosurgical patients, with vascular disease and thrombophlebitis, infection on the dorsum of the hand.
- •Renal and hepatic compromise.
- •drug abusers, with chronic pain syndrome.
- •pregnancy and lactation.
结局指标
主要结局
To evaluate and compare the incidence and severity of pain on propofol injection following intravenous pretreatment with ketamine versus tramadol.
时间窗: To evaluate and compare the incidence and severity of pain during propofol injection following intravenous pretreatment with ketamine or tramadol, assessed at time intervals of 0, 1, 3, 5, 15, 30, 45, and 60 minutes.
次要结局
- To assess the hemodynamic changes, such as heart rate and blood pressure, associated with each pretreatment drug during the induction of anesthesia.
研究者
Dr Ajay Aggarwal
Pacific Medical College and Hospital