NCT06274333 Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort
| NCT ID | NCT06274333 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Al-Azhar University |
| Condition | Percutaneous Nephrolithotripsy (PCNL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-02-28 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60 participants in total. It began in 2024-02-28 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The insertion of a urinary catheter in a patient undergoing a surgical procedure, especially urinary interventions, may lead to catheter-related bladder discomfort (CRBD) with varying degrees of severity during the postoperative period. Paracetamol is a drug with proven efficacy for the management of mild and moderate postoperative pain. Tramadol is a centrally acting, synthetic opioid analgesic with weak opioid agonist properties. It inhibits the detrusor activity by inhibition of type-1 muscarinic (M1) and type-3 muscarinic (M3) receptors. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, with analgesic, sedative, anxiolysis, sympatholytic, and sedative properties, is a very useful associated agent for general anesthesia.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT06274333 clinical trial?
This trial is open to male participants only, aged 20 Years or older, up to 50 Years, studying Percutaneous Nephrolithotripsy (PCNL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06274333 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.
Is NCT06274333 currently recruiting?
Yes, NCT06274333 is actively recruiting participants. Visit ClinicalTrials.gov or contact Al-Azhar University to inquire about joining.
Where is the NCT06274333 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT06274333 clinical trial?
NCT06274333 is sponsored by Al-Azhar University. The trial plans to enroll 60 participants.