Intra-operative low dose Ketamine versus Dexmedetomidine for attenuation of acute post-operative pain following laparoscopic cholecystectomy: A randomized clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the post-operative rescue analgesic requirements in the first 24hours
研究概览
简要总结
This study "Intra-operative low dose Ketamine versus Dexmedetomidine for attenuation of post-operative pain following laparoscopic cholecystectomy: A randomized clinical trial" will be conducted in the Department of Anesthesiology, Regional Institute of Medical Sciences, Imphal. After obtaining ethical clearance and informed written consent, 60 patients of both sexes between the age groups of 18-60years with ASA I and II will be randomized into one of the four groups.
Group D will receive Inj Dexmedetomidine 0.25mcg/kg IV diluted in 5ml Normal Saline, Group K will receive Inj Ketamine 0.25mg/kg IV diluted in 5ml Normal Saline and Group DK will receive a combination of Inj Dexmedetomidine 0.25mcg/kg and Inj Ketamine 0.25mg/kg IV diluted in 5ml Normal Saline, all to be given intra-operatively 20 mins before the anticipated skin closure.
Post operatively, total dose of the rescue analgesics (Inj Diclofenac IM) given in the first 24hours post-op will be compared. Sedation score (Ramsay Sedation Score) will be recorded at 30mins, 1hour, 2hour, 6hour, 12hour and 24hour post-op. Time of first rescue analgesic request when VAS score ≥4 will be recorded. Any episode of nausea, vomiting, dizziness in the first 24hours post-op will be recorded
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 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
- •Age group 18-60years
- •Patients of American Society of Anesthesiology (ASA) grade I and II
- •Undergoing elective laparoscopic Cholecystectomy.
排除标准
- •Conversion to open cholecystectomy
- •Patients with history of significant cardiovascular disease (eg MI within the past 6months).
结局指标
主要结局
To compare the post-operative rescue analgesic requirements in the first 24hours
时间窗: Outcome to be assessed at 24hours post-op
次要结局
- 1. The Sedative effects(30min post-op)
- 2. The time of first rescue analgesic request(When the VAS score more than or equal to 4)
- Other side effects like dizziness, nausea, vomiting(Anytime within the first 24hours post-op)