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Clinical trial

The Effect of Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort: A Randomized, Triple-Blind Clinical Trial

ID
Name
RC.18.1.2024
Description
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.
Trial arms
Trial start
2024-02-28
Estimated PCD
2024-05-30
Trial end
2024-05-30
Status
Recruiting
Phase
Early phase I
Treatment
Dexmedetomidine 0.5 mic/kg
Group I (DP group) will receive dexmedetomidine 0.5 mic/kg and paracetamol 10mg/kg,
Arms:
DP group
Tramadol 1mg/kg
Group II (TP group) will receive tramadol 1mg/kg and paracetamol 10mg/kg.
Arms:
TP group
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.
Arms:
DP group, TP group
Size
60
Primary endpoint
The incidence of catheter-related bladder discomfort (CRBD)
24 hours postoperative
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-03-15

1 organization

3 products

1 indication

Organization
Al-Azhar University
Product
Dexmedetomidine
Indication
Percutaneous Nephrolithotripsy
Product
Tramadol
Product
Paracetamol