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 |
Trial Parameters
Eligibility Fast-Check
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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.