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Clinical Trials in Egypt / NCT06274333
Recruiting Phase 3

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

NCT06274333 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 3
Started
2024-02-28
Last updated
2026-01-06

Condition(s) studied

Percutaneous Nephrolithotripsy (PCNL)

Investigational drug(s) / intervention(s)

Dexmedetomidine 0.5 mic/kgTramadol 1mg/kg →Paracetamol 10mg/kg →

Dexmedetomidine 0.5 mic/kg: Group I (DP group) will receive dexmedetomidine 0.5 mic/kg and paracetamol 10mg/kg,

Tramadol 1mg/kg: Group II (TP group) will receive tramadol 1mg/kg and paracetamol 10mg/kg.

Paracetamol 10mg/kg: Group I (DP group) will receive dexmedetomidine 0.5 mic/kg and paracetamol 10mg/kg. Group II (TP group) will receive tramadol 1mg/kg and paracetamol 10mg/kg.

Study 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

Sex
MALE
Min age
20 Years
Max age
50 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Neveen Kohaf Cairo Cairo Governorate Recruiting

More Al-Azhar University trials in Egypt

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06274333 on ClinicalTrials.gov ↗ ← All trials in Egypt