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

Al-Azhar University

Status and phase: Enrolling; Phase 3

Conditions: Percutaneous Nephrolithotripsy (PCNL)

Treatments: Drug: Dexmedetomidine 0.5 mic/kg; Drug: Tramadol 1mg/kg; Drug: Paracetamol 10mg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT06274333

RC.18.1.2024

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

DP group

Active Comparator group

Description:

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

Treatment:

Drug: Paracetamol 10mg/kg

Drug: Dexmedetomidine 0.5 mic/kg

TP group

Active Comparator group

Description:

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

Treatment:

Drug: Paracetamol 10mg/kg

Drug: Tramadol 1mg/kg