Active — Not RecruitingNot Applicable

Intrathecal Fentanyl and Dexmedetomidine Added to Bupivacaine for Subarachnoid Anaesthesia for Percutaneous Nephrolithotomy

Egypt100 participantsStarted 2025-04-10

Plain-language summary

Regular bupivacaine dosages are linked to considerable sympathetic block, as well as persistent and severe sensory and motor block, which may not be desired for certain individuals. Although diluted bupivacaine at low doses restricts the distribution of spinal block and produces a comparatively quick recovery, it might not offer a sufficient degree of sensory block.Bupivacaine's side effects and dosage requirements are lessened by the potentiating effects of the short-acting lipophilic opioid fentanyl and the more selective α2 agonist dexmedetomidine. These spinal adjuncts are used to extend analgesia in addition to lessening the negative effects of local anesthetics. According to a number of studies, when given intrathecally, α2 receptor agonists will increase the analgesia that subtherapeutic doses of local anesthetics like bupivacaine deliver because of their synergistic effects with little hemodynamic effects.The goal will be to determine if bupivacaine and fentanyl or bupivacaine and dexmedetomidine produced higher-quality anesthesia.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * both sex aged between 18 and 60 years, * belonging to American Society of Anaesthesiologists (ASA) physical status Grade I and II undergoing PCNL under spinal anaesthesia. Exclusion Criteria: * Patients with a history of spine surgery, * infection at the injection site, * coagulopathy, * hypovolemia, * increased intracranial pressure, * indeterminate neurologic disease, * spinal deformities, * communication problems, * known hypersensitivity to local anaesthetics, opioids or dexmedetomidine

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

to evaluate patient satisfaction

Timeframe: at the end of the surgery (assessed up to 40 minutes)

to evaluate the sedation grade

Timeframe: 10 minutes after giving the intervention , then after 30 minutes , then at the end of the surgery (assessed up to 40 minutes)

Trial details

NCT IDNCT06957301

SponsorAlexandria University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05

View on ClinicalTrials.gov More Percutaneous Nephrolithotomy (PCNL) trials