Using Dexmedetomidine or Tramadol with Paracetamol to Reduce Bladder Discomfort After Surgery
The Effect of Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort: A Randomized, Triple-Blind Clinical Trial
This study is testing whether adding Dexmedetomidine or Tramadol to Paracetamol can help reduce bladder discomfort after surgery for people aged 20 to 50.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 50 Years |
| Sex | Male |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT06274333 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of adding Dexmedetomidine or Tramadol to Paracetamol in reducing catheter-related bladder discomfort (CRBD) in patients undergoing percutaneous nephrolithotripsy (PCNL). The study aims to evaluate how these medications can alleviate postoperative pain and discomfort associated with urinary catheters. Participants will receive either Dexmedetomidine or Tramadol alongside Paracetamol during their surgical procedure. The trial focuses on patients aged 20 to 50 years with specific health criteria to ensure safety and efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 to 50 years who are classified as ASA I or II and are scheduled for percutaneous nephrolithotomy.
Not a fit: Patients with a history of psychotic illnesses, current opioid users, or those with bladder obstruction or overactive bladder may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative bladder discomfort for patients undergoing urinary procedures.
How similar studies have performed: Other studies have shown promising results with similar approaches to managing postoperative pain and discomfort, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from 20 - 50 years * ASA (The American Society of Anesthesiologists) I or II, * undergo percutaneous nephrolithotomy (PCNL) Exclusion Criteria: * Patients with history of psychotic illnesses * Opioid users * Bladder obstruction, * Benign prostatic hyperplasia * Overactive bladder (OAB) defined as frequency \_3 times at night or \_8 times within 24 hours.
Where this trial is running
Cairo, Cairo Governorate
- Neveen Kohaf — Cairo, Cairo Governorate, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.