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

Phase 3

Recruiting

• Conditions: Percutaneous Nephrolithotripsy (PCNL)
• Interventions: Drug: Dexmedetomidine 0.5 mic/kg; Drug: Tramadol 1mg/kg; Drug: Paracetamol 10mg/kg

• Registration Number: NCT06274333
• Lead Sponsor: Al-Azhar University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-23
• Study Start: 2024-02-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The incidence of catheter-related bladder discomfort (CRBD)	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 Outcome Measures

Name	Time	Method
Postoperative pain	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)
Surgeon satisfaction	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.
Meperidine requirement	24 hours postoperatively	Total amount of consumed meperidine will be documented
Patient satisfaction	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.

Trial Locations

Locations (1)

Neveen Kohaf; 🇪🇬 Cairo, Egypt