Menu
Recruiting NCT06274333

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

Phase III Interventional Percutaneous Nephrolithotripsy (PCNL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexmedetomidine 0.5 mic/kg, Tramadol 1mg/kg, Paracetamol 10mg/kg.
Who it may be relevant to
Registry conditions: Percutaneous Nephrolithotripsy (PCNL). Basic parameters: 20 years — 50 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Dexmedetomidine 0.5 mic/kg
    Group I (DP group) will receive dexmedetomidine 0.5 mic/kg and paracetamol 10mg/kg,
  • Drug Tramadol 1mg/kg
    Group II (TP group) will receive tramadol 1mg/kg and paracetamol 10mg/kg.
  • Drug 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.

Primary outcome measures

  • The incidence of catheter-related bladder discomfort (CRBD) [Time frame: 24 hours postoperative]
Secondary outcome measures (4)
  • Postoperative pain [Time frame: 24 hours postoperatively]
  • Meperidine requirement [Time frame: 24 hours postoperatively]
  • Patient satisfaction [Time frame: 24 hours postoperatively]
  • Surgeon satisfaction [Time frame: 24 hours postoperatively]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Neveen Kohaf — Cairo

Identifiers

NCT: NCT06274333 · RC.18.1.2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗