NCT07665463 Quality of Recovery-15 After Opioid-free Versus Opioid-based General Anesthesia in Major Urological Surgery
| NCT ID | NCT07665463 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jagiellonian University |
| Condition | Postoperative Recovery |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-09-02 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2026-09-02 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 between the opioid-free anesthesia group and the remifentanil-based anesthesia group using the Quality of Recovery-15 questionnaire. QoR-15 will be assessed before surgery and on postoperative day 7. Secondary objectives include total postoperative oxycodone dose administered via patient-controlled analgesia during the first 24 hours after surgery, postoperative pain intensity measured using the Numeric Rating Scale at 1, 2, 6, 12, and 24 hours after surgery, incidence of postoperative nausea and vomiting, change in serum creatinine from baseline to postoperative day 1, change in white blood cell count from baseline to postoperative day 1, and the ratio of demanded to delivered PCA boluses. Pre-specified subgroup analyses will compare outcomes according to surgical procedure type: laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, and robotic cystectomy. Subgroup-by-treatment interaction tests will be performed. Planned enrollment is approximately 600 patients, with 300 patients per treatment arm. The primary patient-reported recovery endpoint will be assessed on postoperative day 7, while analgesic, pain, and early postoperative safety outcomes will be assessed during the first 24 hours after surgery.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07665463 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Postoperative Recovery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07665463 currently recruiting?
Yes, NCT07665463 is actively recruiting participants. Contact the research team at tomasz.skladzien@uj.edu.pl for enrollment information.
Where is the NCT07665463 trial being conducted?
This trial is being conducted at Krakow, Poland.
Who is sponsoring the NCT07665463 clinical trial?
NCT07665463 is sponsored by Jagiellonian University. The trial plans to enroll 200 participants.