Actively Recruiting
The Effect of Adding Dexmedetomidine or Tramadol to Paracetamol to Reduce Catheter Related Bladder Discomfort: A Randomized, Triple-Blind Clinical Trial
Led by Al-Azhar University · Updated on 2026-01-06
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
A
Al-Azhar University
Lead Sponsor
B
Benha University
Collaborating Sponsor
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 20 to 50 years
- Male patients
- Classified as ASA I or II (healthy or mild systemic disease)
- Undergoing percutaneous nephrolithotomy (PCNL) surgery
You will not qualify if you...
- History of psychotic illnesses
- Current opioid use
- Bladder obstruction
- Benign prostatic hyperplasia
- Overactive bladder defined as urinating 3 or more times at night or 8 or more times within 24 hours
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 hours postoperatively
Participants receive either dexmedetomidine with paracetamol or tramadol with paracetamol to reduce catheter-related bladder discomfort during surgery.
1 treatment and observation period
Trial Site Locations
Total: 1 location
1
Neveen Kohaf
Cairo, Cairo Governorate, Egypt, 11865
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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