A clinical trial to study the effects of three drugs,Tapentadol,Pregabalin, Solifenacin in reducing bladder irritation after urinary catheterisation in patients undergoing Renal stone removal surgery through skin incisio
- Conditions
- Health Condition 1: N200- Calculus of kidney
- Registration Number
- CTRI/2020/12/029594
- Lead Sponsor
- ONE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients of either sex
Aged 18 â?? 60 years
Patients of American Society of Anaesthesiologists grade I & II
Scheduled for elective percutaneous nephrolithotomy under general anaesthesia.
Age < 18 years or > 60 years
Patients of American Society of Anaesthesiologists grade III & IV
History of significant cardiac diseases like previous MI, arrhythmias, high A V conduction blocks, uncontrolled hypertension, angina.
History of chronic use of beta-blockers
Sleep apnoea
Significant liver dysfunction
History of chronic opioid use,
Patients with renal failure ( higher serum creatinine levels >=1.5mg%, urine < 400mI/day), history of urinary tract obstruction / neurogenic bladder / overactive bladder (OAB) ( frequency >3 at night or >8 in 24 hours) / transurethral resection of prostate for benign prostatic hyperplasia
Hypersensitivity to any of the study drugs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of preoperative oral administration of tapentadol, pregabalin and solifenacin on the prevalence and severity of catheter related bladder discomfort in patients undergoing percutaneous nephrolithotomyTimepoint: Severity of CRBD will be evaluated by a blinded assessor at intervals of 0, 1, 2, 4, 6, 12, 24 hours postoperatively on four point severity scale
- Secondary Outcome Measures
Name Time Method ONETimepoint: NA