Percutaneous Nephrolithotripsy (PCNL)Phase 3NCT06274333
Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort
A Phase 3 study testing Dexmedetomidine 0.5 mic/kg, Tramadol 1mg/kg and Paracetamol 10mg/kg in people with Percutaneous Nephrolithotripsy (PCNL), run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Percutaneous Nephrolithotripsy (PCNL)
- What is being tested?
- Dexmedetomidine 0.5 mic/kg, Tramadol 1mg/kg and Paracetamol 10mg/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2024to 30 Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Age from 20 - 50 years
- ASA (The American Society of Anesthesiologists) I or II,
- undergo percutaneous nephrolithotomy (PCNL)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Neveen Kohaf
Cairo, Cairo Governorate, 11865
Neveen Kohaf, Ph.D, +201069482380, nevenabdo@azhar.edu.eg
Hany Bauiomy, M.D
About this study
Official title: The Effect of Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort: A Randomized, Triple-Blind Clinical Trial
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.
- Conditions
- Percutaneous Nephrolithotripsy (PCNL)
- Being tested
- Dexmedetomidine 0.5 mic/kg, Tramadol 1mg/kg, Paracetamol 10mg/kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine 0.5 mic/kgDrug
Group I (DP group) will receive dexmedetomidine 0.5 mic/kg and paracetamol 10mg/kg,
Tramadol 1mg/kgDrug
Group II (TP group) will receive tramadol 1mg/kg and paracetamol 10mg/kg.
Paracetamol 10mg/kgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| DP group | Active comparator | Group I (DP group) will receive dexmedetomidine 0.5 mic/kg and paracetamol 10mg/kg Receives: Drug: Dexmedetomidine 0.5 mic/kg; Drug: Paracetamol 10mg/kg |
| TP group | Active comparator | Group II (TP group) will receive tramadol 1mg/kg and paracetamol 10mg/kg. Receives: Drug: Tramadol 1mg/kg; Drug: Paracetamol 10mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of catheter-related bladder discomfort (CRBD)
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.
Measured: 24 hours postoperative
Secondary outcomes (4)
Postoperative pain
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)
Measured: 24 hours postoperatively
Meperidine requirement
Total amount of consumed meperidine will be documented
Measured: 24 hours postoperatively
Patient satisfaction
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.
Measured: 24 hours postoperatively
Surgeon satisfaction
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.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start28 Feb 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Nephrolithotripsy (PCNL)Studies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Neveen Abd El Maksoad Kohaf, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274333
- Sponsor's protocol ID
- RC.18.1.2024
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon reasonable request from corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Dexmedetomidine or Tramadol to Paracetamol- An Effort to Attenuate Catheter Related Bladder Discomfort: A Randomized, Triple-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06274333
- Acronym / sponsor ID
- RC.18.1.2024
- Conditions
- Percutaneous Nephrolithotripsy (PCNL)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DP group | Active comparator | Drug: Dexmedetomidine 0.5 mic/kg, Drug: Paracetamol 10mg/kgGroup I (DP group) will receive dexmedetomidine 0.5 mic/kg and paracetamol 10mg/kg |
| TP group | Active comparator | Drug: Tramadol 1mg/kg, Drug: Paracetamol 10mg/kgGroup II (TP group) will receive tramadol 1mg/kg and paracetamol 10mg/kg. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age from 20 - 50 years
- ASA (The American Society of Anesthesiologists) I or II,
- undergo percutaneous nephrolithotomy (PCNL)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine 0.5 mic/kgGroup I (DP group) will receive dexmedetomidine 0.5 mic/kg and paracetamol 10mg/kg, | Drug | DP group |
| Tramadol 1mg/kgGroup II (TP group) will receive tramadol 1mg/kg and paracetamol 10mg/kg. | Drug | TP group |
| Paracetamol 10mg/kgGroup 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. | Drug | DP group, TP group |
Primary outcome
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.
4 secondary outcomes
Postoperative pain
Time frame: 24 hours postoperatively
Meperidine requirement
Time frame: 24 hours postoperatively
Patient satisfaction
Time frame: 24 hours postoperatively
Surgeon satisfaction
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Yes. Data will be available upon reasonable request from corresponding author
Related trials for Percutaneous Nephrolithotripsy (PCNL)
Recruiting
Supine vs. Prone Mini-PCNL in Children
Kidney Calculi (or Renal Calculi / Nephrolithiasis), Supine Mini Percutaneous Nephrolithotomy
Not yet recruiting
Metaphylaxis of Infected Kidney Stones After Percutaneous Nephrolithotripsy
Kidney Calculi, Nephrolithiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine 0.5 mic/kg, Tramadol 1mg/kg and Paracetamol 10mg/kg in people with Percutaneous Nephrolithotripsy (PCNL), run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of catheter-related bladder discomfort (CRBD) (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.