Mirabegron for catheter related bladder dysfunctio
Not Applicable
Completed
- Conditions
- Health Condition 1: N70-N77- Inflammatory diseases of female pelvic organs
- Registration Number
- CTRI/2022/05/042735
- Lead Sponsor
- AIIMS Bhubaneswar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 88
Inclusion Criteria
1-Undergoing elective gynecological surgery under general anesthesia requiring postoperative urinary catheterization
2-Surgical duration is less than 4 hr.
Exclusion Criteria
1-History of Coronary artery disease. Hypertension > 150mmHg in initial 48hrs before surgery, Patient on Digoxin, or Drugs are known to prolong the QT/QTc interval.
2-Known bladder dysfunction, such as overactive bladder, neurogenic bladder
3-Pregnant or breastfeeding
4-Intellectual disability
5-Chronic renal insufficiency (creatinine >1.5mg/dL) or liver insufficiency (bilirubin >34.2mmol/L),
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the effect of oral mirabegron 50 mg and placebo (as control) on the incidence of CRBD after elective gynecologic surgery under general anesthesia at 1st hr. after surgeryTimepoint: 1 hr
- Secondary Outcome Measures
Name Time Method 1To compare the effect of oral mirabegron 50 mg and placebo on the incidence of CRBD at 0, 2nd and 6th hr and severity of CRBD at 0, 1st, 2nd and 6th hr after surgery. <br/ ><br>Timepoint: 0, 1st, 2nd and 6th hr;any side effect of mirabegronTimepoint: 6hr;Opioid requirement during the postoperative period following 12 hours of surgery.Timepoint: 12hr;Patient satisfaction between two groups at 6hr using GPE scaleTimepoint: 6hr;PONV between groupsTimepoint: 12hr;to compare VAS score between groupsTimepoint: 12hr