Evaluation of efficacy and safety of hyperbaric ropivacaine in single dose spinal versus low dose combined spinal epidural anaesthesia among cardiac patients undergoing hip fracture surgery: A randomized comparative study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- To compare incidence of intraoperative hypotension
研究概览
简要总结
Hip fractures in elderly population are associated high mortality. Postoperative cardioevents are frequent accounting for around 40% of all reported complications among patients receiving hip fracture surgery. Most patients with hip fractures are fragile and preexisting CVD combined with acute trauma as well as surgical stress could potentially increase the risk of post operative cardiovascular events. Not many comparative studies of CSE versus single dose spinal anaesthesia using hyperbaric ropivacaine in cardiac patients undergoing hip fracture surgery to assess the effect on perioperative hypotension and adverse cardiac effects have been done.We are therefore planning to compare clinical efficacy and safety profile of 0.75% hyperbaric ropivacaine when administered in single dose spinal anesthesia versus low dose combined spinal epidural anesthesia in cardiac patients undergoing hip fracture surgeries. Primary outcome measuredwill be incidence of hypotension and secondary outcomes measured will be sensory-motor block characteristics , quality of anaesthesia, hemodynamic profile, adverse effects and adverse cardiac events occurring during first 48 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of 18 years or above, of both sex, ASA grade 2 to 4, having preexisting cardiac disease and undergoing elective hip fracture surgery of expected duration of 2 hours.
排除标准
- •Any contraindications to spinal anesthesia, allergic to local anesthetics, patient refusal, if patient is converted to GA and pregnancy.
结局指标
主要结局
To compare incidence of intraoperative hypotension
时间窗: To compare incidence of intraoperative hypotension at baseline, time of induction, at 3, 6,9 12, 15 , 20, 25, 30,35,40,45,50,55,60,75,90,105,120,135 and 150 minutes after induction.
次要结局
- To compare sensory & motor block characteristics(Sensory & motor block characteristics were noted at 3, 6, 9, 12, 15 & 20 minutes after induction)
- Hemodynamic profile including systolic BP,diastolic BP,Mean Arterial pressure, Heart Rate & oxygen saturation(Hemodynamic vitals noted at baseline, time of induction, 3,6,9,12,15,20,25,30,35,40,45,50,55,60,75,90,105,120,135 & 150 minutes post induction)
- Adverse cardiac events occurring intraoperatively & postoperatively(Adverse cardiac effects noted for 48 hours postoperatively)
研究者
Dr Udita Naithani
R.N.T medical college