Percutaneous Nephrolithotripsy (PCNL)
Conditions
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.
Interventions
DRUGDexmedetomidine 0.5 mic/kg
Group I (DP group) will receive dexmedetomidine 0.5 mic/kg and paracetamol 10mg/kg,
DRUGTramadol 1mg/kg
Group II (TP group) will receive tramadol 1mg/kg and paracetamol 10mg/kg.
DRUGParacetamol 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.
Sponsors
Benha University
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of catheter-related bladder discomfort (CRBD) | 24 hours postoperative | The incidence of catheter-related bladder discomfort (CRBD) will be assessed at 30 minutes and 1, 2, 4, 6,8,10,12 and 24 hours postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 24 hours postoperatively | Postoperative pain will be assessed with the Visual Analog Scale (VAS) (0, no discomfort and no pain; 10, a high level of discomfort and maximum pain) |
| Meperidine requirement | 24 hours postoperatively | Total amount of consumed meperidine will be documented |
| Patient satisfaction | 24 hours postoperatively | Patients' satisfaction was measured immediately postoperative and after 24 hours using a five-point Likert scale consisting of very dissatisfied, dissatisfied, unsure, satisfied, and very satisfied. |
| Surgeon satisfaction | 24 hours postoperatively | Surgeon' satisfaction was measured immediately postoperative and after 24 hours using a five-point Likert scale consisting of very dissatisfied, dissatisfied, unsure, satisfied, and very satisfied. |
Countries
Egypt
Outcome results
None listed