Skip to content

Mirabegron for catheter related bladder dysfunction

Effect of mirabegron on catheter-related bladder dysfunction following elective gynecological surgery under general anesthesia- a randomized controlled trial."

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042735
Enrollment
90
Registered
2022-05-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N70-N77- Inflammatory diseases of female pelvic organs

Interventions

Intervention1: Tab Mirabegron50 mg: At 24 and 1 hr before surgery Control Intervention1: look alike placebo Placebo: similar time as intervention

Sponsors

AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1-Undergoing elective gynecological surgery under general anesthesia requiring postoperative urinary catheterization 2-Surgical duration is less than 4 hr.

Exclusion criteria

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),

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. 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

Countries

India

Contacts

Public ContactDr Alok Kumar Sahoo

AIIMS, Bhubaneswar

alokks108@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026