Comparison of the effect of intravenous bolus and infusion of dexmedetomidine versus ketamine given intraoperative on postoperative analgesia in fracture femur patients operated under subarachnoid block - A prospective randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- To compare postoperative analgesia and duration of analgesia after fracture
研究概览
简要总结
This is a prospective randomized controlled trial comparing the effect of dexmedetomidine versus ketamine given intraoperative o postoperative analgesia in fracture femur patients operated under subarachnoid block. Total 75 patients will be recruited with 25 in each group (group dexmedetomidine, group ketamine, control group). The primary outcome is to compare postoperative analgesia and duration of analgesia after fracture femur surgery in dexmedetomidine versus ketamine group and the secondary outcome is to assess cumulative rescue analgesic requirement in different groups, to compare hemodynamic effects, side effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex 2)Patients with ASA grade 1 and grade 2 3)Patients aged between 18 to 65 years 4)Patients with femur fractures.
排除标准
- •Refusal to participate in the study 2)Peripheral neuropathy 3)Patients having coagulation or bleeding abnormalities 4)Local site infection 5)Altered mental status 6)Patients with significant coexisting diseases like ischemic heart disease, impaired renal function and severe liver disease 7)Patients on beta blockers 8)Patients allergic to bupivacaine, dexmedetomidine, ketamine.
结局指标
主要结局
To compare postoperative analgesia and duration of analgesia after fracture
时间窗: 1 year
femur surgery in dexmedetomidine versus ketamine group
时间窗: 1 year
次要结局
- cumulative analgesic requirements, hemodynamic effects, side effects(1 year)