Comparison of efficacy of thoracic segmental spinal anaesthesia versus general anaesthesia in patient undergoing percutaneous nephrolithotomy: a randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Quality of Recovery following surgery
研究概览
简要总结
This trial is a randomised open label prospective parallel arm active controlled trial to compare the quality of Recovery at 24 hours following surgery as a primary outcome and to compare the length of stay in hospital in post operative , comparing post operative nausea vomiting in both groups ,cost-benefit analysis ,time to first analgesia as secondary outcomes between General anaesthesia and Thoracic Spinal anaesthesia group of patients undergoing elective percutaneous nephrolithotomy surgery (PCNL) for renal stone disease In AIIMS, Rishikesh in approximately next 18 months from the expected date of first allotment
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •American society of Anaesthesiologist Grade I-III patients with unilateral And single renal stone.
排除标准
- •Pregnant patients Patients with severe systemic medical illness ASA GRADE IV-V Patients having BMI more than 40 Patients with local site infections Patients with known bleeding disorder or coagulopathy Patients with suspected raised intracranial pressure Patients having spinal deformities.
结局指标
主要结局
Quality of Recovery following surgery
时间窗: Quality of recovery will be assessed using a questionnaire night before surgery and at 24 hours post surgery
次要结局
- Recovery Time in post anaesthesia care unit (PACU)(At every 15 minutes intervals after surgery gets over till patient gets discharged from PACU)
- Compare the Length of stay in the hospital(from the day of surgery till the patient gets discharged)
- compare time to first analgesia in both groups(In Post operative care unit(PACU) till the patient gets discharged from PACU)
- To compare Post operative nausea and vomiting in both groups(At every 15 minutes intervals after surgery gets over till patients get discharged from post operative care unit(PACU))
- To do cost benefit analysis in both groups(from medical records and bills at the time of discharge)