Role of oral melatonin in prevention of catheter related bladder discomfort (CRBD) in patients undergoing surgery for benign prostate hypertrophy

Pre-emptive role of oral melatonin in prevention of catheter related bladder discomfort (CRBD) in patients undergoing transurethral resection of prostate (TURP) surgery: A prospective randomized controlled study - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/062153

Enrollment

Registered

2024-01-31

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

Interventions

Intervention1: Melatonin: Effectiveness of oral melatonin for CRBD. 5mg of oral melatonin one day prior to scheduled surgery. Like premedication, melatonin will be given night of day before surgery an

Eligibility

Inclusion criteria

Inclusion criteria: 1. American Society of Anaesthesiologists - Physical Status grade 1 and 2, 2. Patients undergoing elective TURP under Subarachnoid block and 3. Patients who undergoing urinary catheterisation.

Exclusion criteria

Exclusion criteria: 1. Patents with liver and renal failure. 2. Refusal or contraindication for spinal anaesthesia. 3. Patients on chronic analgesics. 4. Psychiatric Disorders and inability to communicate. 5. Overactive bladder, neurogenic bladder, bladder outflow obstruction. 6. Patients with autoimmune diseases such as rheumatoid arthritis and post organ transplant.

Design outcomes

Primary

Measure	Time frame
Incidence and severity of CRBDTimepoint: 0,2,8,12 and 24 hour	—

Secondary

Measure	Time frame
SedationTimepoint: On table and 24 hours;Patient satisfaction scoreTimepoint: At 6th hour;Visual analogue scaleTimepoint: 0,2,8,12 and 24 hour	—

Countries

India

Contacts

Public ContactDr Amrita Rath

Institute of Medical Sciences

rambadan.vns@gmail.com9336910579

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 27, 2026