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

Last updated: July 30, 2024
Sponsor: Al-Azhar University
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Paracetamol 10mg/kg

Dexmedetomidine 0.5 mic/kg

Tramadol 1mg/kg

Clinical Study ID

NCT06274333
RC.18.1.2024
  • Ages 20-50
  • Male

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Age from 20 - 50 years

  • ASA (The American Society of Anesthesiologists) I or II,

  • undergo percutaneous nephrolithotomy (PCNL)

Exclusion

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.

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: Paracetamol 10mg/kg
Phase: 3
Study Start date:
February 28, 2024
Estimated Completion Date:
November 30, 2024

Connect with a study center

  • Neveen Kohaf

    Cairo, 11865
    Egypt

    Active - Recruiting

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