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Phase 3
Age: 20Years - 50Years
MALE
ID06274333

Study of Adding Dexmedetomidine or Tramadol to Paracetamol to Reduce Bladder Discomfort After Urinary Catheter Insertion During Kidney Stone Surgery

Led by Al-Azhar University · Updated on 2026-01-06

60

Participants Needed

1

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying catheter-related bladder discomfort CRBD that can occur after urinary catheter insertion during surgical procedures, particularly urinary interventions. This clinical trial evaluates the effects of adding dexmedetomidine or tramadol to paracetamol in managing CRBD and postoperative pain. The study is a randomized, triple-blind, phase 3 trial aimed at understanding how these drug combinations may reduce discomfort after surgery. Participants will be divided into two groups. One group will receive dexmedetomidine at 0.5 micrograms per kilogram combined with paracetamol at 10 milligrams per kilogram, while the other group will receive tramadol at 1 milligram per kilogram plus paracetamol at the same dose. These treatments will be administered during the surgical period to assess their effects on bladder discomfort and pain. During the study, researchers will monitor participants for 24 hours after surgery to measure the incidence of CRBD as the primary outcome. Secondary outcomes include evaluating postoperative pain, the need for additional pain medication meperidine, and satisfaction levels of both patients and surgeons. The study involves adult male patients aged 20 to 50 years undergoing percutaneous nephrolithotomy PCNL.

CONDITIONS

Brief Title

Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort

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