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

NCT ID: NCT06274333

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-28

Study Completion Date

2026-09-30

Brief Summary

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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

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Conditions

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Percutaneous Nephrolithotripsy (PCNL)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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DP group

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine 0.5 mic/kg

Intervention Type DRUG

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

Paracetamol 10mg/kg

Intervention Type 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.

TP group

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

Group Type ACTIVE_COMPARATOR

Tramadol 1mg/kg

Intervention Type DRUG

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

Paracetamol 10mg/kg

Intervention Type 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.

Interventions

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Dexmedetomidine 0.5 mic/kg

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

Intervention Type DRUG

Tramadol 1mg/kg

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role collaborator

Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Neveen Abd El Maksoad Kohaf

Lecturer of Clinical Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Neveen Kohaf

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Neveen Kohaf, Ph.D

Role: primary

+201069482380

Other Identifiers

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RC.18.1.2024

Identifier Type: -

Identifier Source: org_study_id

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