[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545310":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":12,"locations":24,"responsibleParty":45,"collaborators":12,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":12,"eligibilityCriteria":54,"healthyVolunteers":51,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":12,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":12,"overallStatus":26,"whyStopped":12,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Jagiellonian University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Opioid-based anesthesia (remifentanil)","NO_INTERVENTION","Opioid-based general anesthesia. Premedication includes dexamethasone, paracetamol, metamizole, magnesium sulfate, and ibuprofen. Induction with propofol and rocuronium under TOF monitoring. Maintenance with sevoflurane titrated to MAC; intraoperative analgesia provided by remifentanil infusion (total intraoperative dose recorded). Regional analgesia by procedure: bilateral ESP block (nephrectomy), bilateral QL block (prostatectomy), and continuous epidural ropivacaine infusion (cystectomy). Postoperative analgesia: oxycodone PCA (2 mg bolus, 10-min lockout, no background infusion) with paracetamol and metamizole.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Opioid-free anesthesia (OFA)","EXPERIMENTAL","Opioid-free general anesthesia. Premedication includes dexamethasone, paracetamol, metamizole, magnesium sulfate, ibuprofen, and dexmedetomidine (OFA group only). Induction with propofol, ketamine (OFA group only), and rocuronium under TOF monitoring. Maintenance with sevoflurane titrated to MAC; intraoperative analgesia provided by a continuous dexmedetomidine\u002Fketamine infusion with rescue boluses for tachycardia or hypertension. Regional analgesia by procedure: bilateral ESP block (nephrectomy), bilateral QL block (prostatectomy), and continuous epidural ropivacaine infusion (cystectomy). Postoperative analgesia: oxycodone PCA (2 mg bolus, 10-min lockout, no background infusion) with paracetamol and metamizole.",[18],"Other: anesthesia without opioids",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"anesthesia without opioids","Opioid free general anesthesia",[14],[25],{"facility":5,"status":26,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"RECRUITING","Krakow","Lesser Poland Voivodeship","31501","Poland","PL",{"type":33,"coordinates":34},"Point",[35,36],19.93658,50.06143,{"lat":36,"lon":35},[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Tomasz Skladzien, phd md","CONTACT","506602250","48","t.skladzien@interia.pl",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Tomasz Skladzien","MD PHD","100545310","opioid-free-anesthesia-as-an-alternative-to-general-anesthesia-in-abdominal-surgery-100545310",false,"NCT06380244","Opioid-free Anesthesia as an Alternative to General Anesthesia in Abdominal Surgery","Inclusion Criteria:\n\n* Adults aged 18-75 years scheduled for elective urological surgery under general anesthesia: laparoscopic or robotic nephrectomy, laparoscopic or robotic prostatectomy, or laparoscopic or robotic cystectomy.\n* Ability to operate a patient-controlled analgesia (PCA) pump postoperatively.\n* Ability to understand and use the Numeric Rating Scale (NRS) for pain assessment.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Patient's refusal to participate.\n* Inability to operate the PCA pump.\n* Inability to understand the NRS pain scale.\n* Known hypersensitivity to any of the study drugs (anesthetics, ketamine, dexmedetomidine, ropivacaine, oxycodone, metamizole, paracetamol, ibuprofen).\n* Second- or third-degree atrioventricular block, or symptomatic bradycardia.\n* Chronic opioid use.\n* Contraindication to the planned regional anesthesia technique (e.g. coagulopathy or therapeutic anticoagulation, infection at the puncture site).","ALL","18 Years","75 Years",{"count":59,"type":60},600,"ESTIMATED","INTERVENTIONAL",[63],"NA","Opioid-free anesthesia (OFA) is a multimodal technique that eliminates intraoperative opioids by combining dexmedetomidine, ketamine, lidocaine, NSAIDs, and regional analgesia. Growing evidence suggests OFA reduces postoperative opioid consumption, opioid-related adverse effects, and may have favorable oncological implications in cancer surgery.\n\nThis randomized controlled trial compares OFA with opioid-based anesthesia (remifentanil) in patients undergoing elective urological surgery: laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, and robotic cystectomy.\n\nThe PRIMARY OBJECTIVE is to compare the total postoperative oxycodone dose (mg) administered via patient-controlled analgesia (PCA) during the first 24 hours after surgery between the OFA and remifentanil groups.\n\nSECONDARY OBJECTIVES include: postoperative pain intensity (NRS) at 1, 2, 6, 12, and 24 hours; incidence of postoperative nausea and vomiting (PONV); change in serum creatinine from baseline to postoperative day 1; change in white blood cell (WBC) count from baseline to postoperative day 1; and the ratio of demanded to delivered PCA boluses.\n\nPRE-SPECIFIED SUBGROUP ANALYSES will compare outcomes by surgical procedure type: laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, and robotic cystectomy. Subgroup-by-treatment interaction tests will be performed and reported as forest plots.\n\nPlanned enrollment: approximately 600 patients (300 per arm). Follow-up: 24 hours postoperatively.",[66,67,68],"Analgesics, Opioid","Anesthesia, Endotracheal","Anesthesia, General","2026-06-18",{"date":71,"type":72},"2026-06-24","ACTUAL",{"date":74,"type":72},"2024-03-10",{"date":76,"type":60},"2026-12-31",{"name":5,"class":6},1]