Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06274333

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Percutaneous Nephrolithotripsy (PCNL)

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Neveen Kohaf

Cairo, Cairo Governorate, 11865, Egypt

Location status: Recruiting

Location contact

Ahmed M. Abosakaya, M.D

PRINCIPAL_INVESTIGATOR

Hany Bauiomy, M.D

PRINCIPAL_INVESTIGATOR

Neveen Kohaf, Ph.D

CONTACT

[email protected]

+201069482380

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine 0.5 mic/kg

Drug

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

Tramadol 1mg/kg

Drug

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

Paracetamol 10mg/kg

Drug

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 outcomes

  1. The incidence of catheter-related bladder discomfort (CRBD)

    Time frame: 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 outcomes

  1. Postoperative pain

    Time frame: 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)

  2. Meperidine requirement

    Time frame: 24 hours postoperatively

    Total amount of consumed meperidine will be documented

  3. Patient satisfaction

    Time frame: 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.

  4. Surgeon satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Collaborators

  • Benha University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2024
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.