Role of lidocaine and dexmedetomidine containing irrigation fluid in prevention of post operative catheter related bladder discomfort in patients undergoing percutaneous nephrolithotomy and ureteroscopic lithotripsy: A double blinded randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Incidence of CRBD(catheter related bladder symptoms) in the three groups ( lidocaine vs dexmedetomidine containing irrigation fluid intravesical vs normal saline) in patients undergoing percutaneous nephrolithotomy & ureteroscopic immediately after surgery at 0,1,2,6 hrs
研究概览
简要总结
This study is a randomised , double blind , parallel group , single-centre trial to study the role of lidocaine and dexmedetomidine containing irrigation fluid in prevention of post operative catheter related bladder discomfort in patients undergoing percutaneous nephrolithotomy and ureteroscopic lithotripsy. The primary outcome measures will be to compare the incidence of CRBD (catheter related bladder discomfort) in the three groups immediately after surgery at 0,1,2,6 h in males of 20-60yrs undergoing elective surgery. The secondary outcomes will be to compare incidence of bladder, suprapubic or urethral pain at 0,1,2,6 hours after surgery , use of rescue medications (ketorolac, tramadol) , identification of side effects of lidocaine/dexmedetomidine and rescue medications , patient satisfaction using global perceived effects on a 7- pointer scale (GPES) and surgical complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •Age group- 20-60years Male patients ASA status- I or II Patients scheduled for elective PCNL/URSL surgery.
排除标准
- •Allergy to lidocaine.
- •Known case of arrhythmias, heart block, atrial fibrillation.
- •Case of liver cirrhosis.
- •Severe heart disease, respiratory disease.
- •Patient previously on catheter, stent , previous urethral instrumentation.
结局指标
主要结局
Incidence of CRBD(catheter related bladder symptoms) in the three groups ( lidocaine vs dexmedetomidine containing irrigation fluid intravesical vs normal saline) in patients undergoing percutaneous nephrolithotomy & ureteroscopic immediately after surgery at 0,1,2,6 hrs
时间窗: 0,1,2,6 hrs
次要结局
- Secondary outcomes will be to compare incidence of bladder, suprapubic or urethral pain at 0,1,2,6 hours after surgery,(Use of rescue medications (ketorolac, tramadol),)