RecruitingPhase 3NCT06274333

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

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


Sponsor

Al-Azhar University

Enrollment

60 participants

Start Date

Feb 28, 2024

Study Type

INTERVENTIONAL

Conditions

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: MALEMin Age: 20 YearsMax Age: 50 Years

Inclusion Criteria3

  • Age from 20 - 50 years
  • ASA (The American Society of Anesthesiologists) I or II,
  • undergo percutaneous nephrolithotomy (PCNL)

Exclusion Criteria5

  • 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.

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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.


Locations(1)

Neveen Kohaf

Cairo, Cairo Governorate, Egypt

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NCT06274333