Comparative study of intraperitoneal instillation of levobupivacaine (0.25%) plus dexmedetomidine versus ropicacaine (0.25%) plus dexmedetomidine for post operative analgesia in patients undergoing laparoscopic cholecystectomy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 2.Duration of postoperative analgesia (hours).
研究概览
简要总结
The aim of the presentstudy is to compare and evaluate the effects of intraperitoneal instillation of0.25% levobupivacaine plus dexmedetomidine versus 0.25% ropivacaine plusdexmedetomidine for postoperative analgesia in patients undergoing laparoscopiccholecystectomy. The aim will be accomplished by carrying out a study on 90patients randomly divided into 3 groups of 30 each in the age group of 18-65years, of either sex, of ASA grade I, II and III selected for laparoscopiccholecystectomy after proper preanaesthetic check up. Postoperative analgesiawill be achieved in group L by using 40 ml of 0.25% levobupivacaine plusdexmedetomidine @ 1µgm per Kg Body weight and in group R by using 40 ml of0.25% ropivacaine plus dexmedetomidine @ 1µgm per Kg Body weight and Group Cwill be given 40 ml Normal Saline. Thethree groups will be compared with respect to haemodynamic changes, onset andregression of analgesia, requirement of rescue analgesia, side effects andcomplications with the help of scale discussed in plan. The observation will berecorded and the results will be statistically analysed.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients of
- •65 years of either sex
- •All ASA grade I and II admitted in the Surgery department.
- •Patients posted for laparoscopic cholecystectomy surgery under general anaesthesia.
排除标准
- •Pregnant and lactating women Patients with morbid obesity i.e. BMI of 35 Kg/m
- •Patients on psychotropic or adrenergic drugs Refusal by patient to enlist in study â—Patients with chronic pain syndrome.
- •â—History of previous abdominal surgery.
- •Allergy to study drug.
结局指标
主要结局
2.Duration of postoperative analgesia (hours).
时间窗: 8 hours
1.To study the post-operative analgesic effect of 0.25% levobupivacaine plus dexmedetomidine with 0.25% ropivacaine plus dexmedetomidine with Normal Saline (Control Group) following intra-peritoneal instillation in laparoscopic cholecystectomy.
时间窗: 8 hours
3.To assess the need of rescue analgesics in post-operative period in all the groups.
时间窗: 8 hours
次要结局
- 1.Haemodynamic changes.(2.Any side effects or complications (confusion, dizziness, auditory and visual disturbances, convulsions, hypertension and cardiovascular collapse, tachycardia, arrthymias and respiratory depression).)