[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644228":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":37,"responsibleParty":55,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":88,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Jagiellonian University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Opioid-based general anesthesia with remifentanil","ACTIVE_COMPARATOR","Participants assigned to this arm will receive opioid-based general anesthesia with intraoperative remifentanil infusion. Premedication includes dexamethasone, paracetamol, metamizole, magnesium sulfate, and ibuprofen. Anesthesia induction will be performed with propofol and rocuronium under train-of-four monitoring. Maintenance of anesthesia will be provided with sevoflurane titrated to minimum alveolar concentration. Intraoperative analgesia will be provided by remifentanil infusion, and the total intraoperative remifentanil dose will be recorded.\n\nProcedure-specific regional analgesia will include bilateral erector spinae plane block for nephrectomy, and continuous epidural ropivacaine infusion for cystectomy.\n\nPostoperative analgesia will include oxycodone patient-controlled analgesia with 2 mg boluses, a 10-minute lockout interval, and no background infusion, together with paracetamol and metamizole.",[13],"Drug: Remifentanil-based general anesthesia",{"label":15,"type":16,"description":17,"interventionNames":18},"Opioid-free general anesthesia","EXPERIMENTAL","Participants assigned to this arm will receive opioid-free general anesthesia. Premedication includes dexamethasone, paracetamol, metamizole, magnesium sulfate, ibuprofen, and dexmedetomidine. Anesthesia induction will be performed with propofol, ketamine, and rocuronium under train-of-four monitoring. Maintenance of anesthesia will be provided with sevoflurane titrated to minimum alveolar concentration.\n\nIntraoperative analgesia and sympatholysis will be provided by continuous dexmedetomidine, ketamine, and lidocaine infusion, with rescue treatment for tachycardia or hypertension according to the study protocol.\n\nProcedure-specific regional analgesia will include bilateral erector spinae plane block for nephrectomy, bilateral quadratus lumborum block for prostatectomy, and continuous epidural ropivacaine infusion for cystectomy.\n\nPostoperative analgesia will include oxycodone patient-controlled analgesia with 2 mg boluses, a 10-minute lockout interval, and no background infusion, to",[19],"Drug: Opioid-free general anesthesia",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Remifentanil-based general anesthesia","General anesthesia with intraoperative remifentanil infusion, sevoflurane maintenance, non-opioid co-analgesics, procedure-specific regional analgesia, and standardized postoperative analgesia with oxycodone patient-controlled analgesia.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"General anesthesia without intraoperative opioids using dexmedetomidine, ketamine, lidocaine, sevoflurane, non-opioid co-analgesics, procedure-specific regional analgesia, and standardized postoperative analgesia with oxycodone patient-controlled analgesia.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Tomasz Skladzien, MD PHD","CONTACT","12 400 18 00","+48","tomasz.skladzien@uj.edu.pl",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University","Cracow","Lesser Poland Voivodeship","30-688","Poland","PL",{"type":46,"coordinates":47},"Point",[48,49],19.93658,50.06143,{"lat":49,"lon":48},[52],{"name":53,"role":33,"phone":54,"phoneExt":26,"email":36},"Tomasz Skladzien, phd md","+48 12 400 1800",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Tomasz Skladzien","MD PhD","100644228","quality-of-recovery-15-after-opioid-free-versus-opioid-based-general-anesthesia-in-major-urological-surgery-100644228",false,"NCT07665463","Quality of Recovery-15 After Opioid-free Versus Opioid-based General Anesthesia in Major Urological Surgery","Uality of Recovery-15 After Opioid-free Versus Opioid-based General Anesthesia in Patients Undergoing Elective Major Urological Surgery: A Randomized Controlled Trial","QoR-OFA-URO","Inclusion Criteria:\n\n* Adults aged 18 to 75 years.\n* Scheduled for elective major urological surgery under general anesthesia, including laparoscopic or robotic nephrectomy, laparoscopic or robotic prostatectomy, or laparoscopic or robotic cystectomy.\n* Ability to operate a patient-controlled analgesia pump postoperatively.\n* Ability to understand and use the Numeric Rating Scale for pain assessment.\n* Ability to understand and complete the Quality of Recovery-15 questionnaire.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Patient refusal to participate.\n* Inability to operate the patient-controlled analgesia pump.\n* Inability to understand the Numeric Rating Scale for pain assessment.\n* Inability to understand or complete the Quality of Recovery-15 questionnaire.\n* Known hypersensitivity to any of the study drugs, including anesthetics, ketamine, dexmedetomidine, lidocaine, ropivacaine, oxycodone, metamizole, paracetamol, or ibuprofen.\n* Second- or third-degree atrioventricular block.\n* Symptomatic bradycardia.\n* Chronic opioid use.\n* Contraindication to the planned regional anesthesia technique, including coagulopathy, therapeutic anticoagulation, or infection at the puncture site.","ALL","18 Years","75 Years",{"count":71,"type":72},200,"ESTIMATED","INTERVENTIONAL",[75],"NA","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.\n\nOpioid-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.\n\nParticipants will undergo elective urological surgery, including laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, or robotic cystectomy.\n\nThe 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.\n\nSecondary 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.\n\nPre-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.\n\nPlanned 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.",[78,79,80,81],"Postoperative Recovery","Anesthesia, General","Analgesics, Opioid","Urologic Surgical Procedure",[83,84,85,86,87],"Quality of Recovery-15","QoR-15","Opioid-free anesthesia","Remifentanil","Urological surgery","NOT_YET_RECRUITING","2026-06-18",{"date":91,"type":92},"2026-06-24","ACTUAL",{"date":94,"type":72},"2026-07-01",{"date":96,"type":72},"2027-12-31",{"name":5,"class":6},1]