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Quality of Recovery-15 After Opioid-free Versus Opioid-based General Anesthesia in Major Urological Surgery

RecruitingNAAges 18 Years - 75 YearsAllJagiellonian University
NCT07665463 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This randomized controlled trial evaluates postoperative quality of recovery assessed with the Quality of Recovery-15 questionnaire in adult patients undergoing elective major urological surgery under opioid-free versus opioid-based general anesthesia. Opioid-free anesthesia is a multimodal anesthetic technique that avoids intraoperative opioids by combining non-opioid analgesic and sympatholytic agents such as dexmedetomidine, ketamine, lidocaine, non-steroidal anti-inflammatory drugs, and regional analgesia. Opioid-based general anesthesia in this trial includes intraoperative remifentanil infusion. Participants will undergo elective urological surgery, including laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, or robotic cystectomy. The primary objective is to compare patient-reported quality of recovery betw

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged 18 to 75 years. * Scheduled for elective major urological surgery under general anesthesia, including laparoscopic or robotic nephrectomy, laparoscopic or robotic prostatectomy, or laparoscopic or robotic cystectomy. * Ability to operate a patient-controlled analgesia pump postoperatively. * Ability to understand and use the Numeric Rating Scale for pain assessment. * Ability to understand and complete the Quality of Recovery-15 questionnaire. * Written informed consent. Exclusion Criteria: * Patient refusal to participate. * Inability to operate the patient-controlled analgesia pump. * Inability to understand the Numeric Rating Scale for pain assessment. * Inability to understand or complete the Quality of Recovery-15 questionnaire. * Known hypersensitivity to any of the study drugs, including anesthetics, ketamine, dexmedetomidine, lidocaine, ropivacaine, oxycodone, metamizole, paracetamol, or ibuprofen. * Second- or third-degree atrioventricular block. * Symptomatic bradycardia. * Chronic opioid use. * Contraindication to the planned regional anesthesia technique, including coagulopathy, therapeutic anticoagulation, or infection at the puncture site.
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What it tests

  • Remifentanil-based general anesthesia
  • Opioid-free general anesthesia
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Where

1 site
Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University
Krakow, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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