[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658675":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":23,"interventions":36,"overallOfficials":13,"centralContacts":13,"locations":13,"responsibleParty":46,"collaborators":13,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":13,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":13,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":79,"whyStopped":13,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":13},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Quality of Recovery-15 (QoR-15) Score","The Quality of Recovery-15 (QoR-15) questionnaire assesses patient-reported recovery across five domains: physical comfort, physical independence, psychological support, pain, and emotional state. The tool consists of 15 items, each scored from 0 to 10, resulting in a total score ranging from 0 to 150. Higher scores represent better postoperative quality of recovery.","24 hours postoperatively",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":20},"DOUBLE",[21,22],"PARTICIPANT","OUTCOMES_ASSESSOR",[24,30],{"label":25,"type":26,"description":27,"interventionNames":28},"Conventional Opioid-Based General Anesthesia","ACTIVE_COMPARATOR","Participants receive standard general anesthesia induced with IV propofol, muscle relaxation maintained with IV cisatracurium, and anesthesia maintained with sevoflurane. Systemic analgesia is provided with IV fentanyl 2 µg\u002Fkg before induction, followed by 0.5 µg\u002Fkg IV boluses as clinically indicated by hemodynamic response. Postoperatively, all patients receive IV paracetamol 1 g every 8 hours, with IV nalbuphine 0.1 mg\u002Fkg available every 4 hours as rescue analgesia for NRS pain scores ≥ 4 (maximum single dose 20 mg).",[29],"Drug: Fentanyl",{"label":31,"type":32,"description":33,"interventionNames":34},"Ketamine-Dexmedetomidine Opioid-Sparing Anesthesia","EXPERIMENTAL","Participants receive opioid-sparing general anesthesia induced with IV propofol, muscle relaxation maintained with IV cisatracurium, and anesthesia maintained with sevoflurane. Analgesic maintenance is provided with an IV ketamine bolus of 0.25 mg\u002Fkg followed by a continuous infusion of 0.25 mg\u002Fkg\u002Fh, combined with an IV dexmedetomidine loading dose of 0.5 µg\u002Fkg over 10 minutes followed by an infusion of 0.3 µg\u002Fkg\u002Fh. Postoperatively, all patients receive IV paracetamol 1 g every 8 hours, with IV nalbuphine 0.1 mg\u002Fkg available every 4 hours as rescue analgesia for NRS pain scores ≥ 4 (maximum single dose 20 mg).",[35],"Drug: Ketamine and Dexmedetomidine",[37,42],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":13},"DRUG","Ketamine and Dexmedetomidine","Intravenous ketamine bolus of 0.25 mg\u002Fkg administered before induction, followed by a continuous infusion of 0.25 mg\u002Fkg\u002Fh. Combined with intravenous dexmedetomidine loading dose of 0.5 µg\u002Fkg administered over 10 minutes, followed by a continuous infusion of 0.3 µg\u002Fkg\u002Fh throughout surgery.",[31],{"type":38,"name":43,"description":44,"armGroupLabels":45,"otherNames":13},"Fentanyl","Intravenous fentanyl administered at a dose of 2 µg\u002Fkg before induction, followed by supplementary boluses of 0.5 µg\u002Fkg IV as needed according to intraoperative hemodynamic response.",[25],{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Mohamed Osman Mohamed Ibrahim","Resident","100658675","phase-4-effect-of-a-low-dose-ketamine-dexmedetomidine-based-opioid-sparing-anesthesia-protocol-on-postoperative-quality-of-recovery-after-percutaneous-nephrolithotomy-100658675",false,"NCT07855068","Effect of a Low-Dose Ketamine-Dexmedetomidine-Based Opioid-Sparing Anesthesia Protocol on Postoperative Quality of Recovery After Percutaneous Nephrolithotomy","Effect of a Low-Dose Ketamine-Dexmedetomidine-Based Opioid-Sparing Anesthesia Protocol on Postoperative Quality of Recovery After Percutaneous Nephrolithotomy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adult patients scheduled for elective percutaneous nephrolithotomy (PCNL) under general anesthesia.\n* Age between 18 and 60 years.\n* American Society of Anesthesiologists (ASA) physical status I or II.\n* Expected surgical duration ≤ 2 hours.\n* Ability to understand and complete the Quality of Recovery-15 (QoR-15) questionnaire.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Patient refusal to participate.\n* Known allergy or contraindication to ketamine, dexmedetomidine, fentanyl, or other study medications.\n* Significant cardiovascular disease.\n* Uncontrolled hypertension.\n* Clinically significant bradycardia.\n* Severe hepatic or renal impairment.\n* Psychiatric illness or active psychosis.\n* Chronic opioid use.\n* Chronic pain syndromes requiring regular analgesics.\n* Pregnancy.\n* Conversion to open surgery.\n* Inability to complete postoperative assessments.","ALL","18 Years","60 Years",{"count":61,"type":62},100,"ESTIMATED","INTERVENTIONAL",[65],"PHASE4","Percutaneous nephrolithotomy (PCNL) is a minimally invasive surgical procedure used to remove large or complex kidney stones. Although effective, dilation of the surgical tract and the placement of a nephrostomy tube cause significant postoperative pain. Conventional general anesthesia relies heavily on opioid medications (such as fentanyl) for pain control; however, opioids can cause unwanted side effects, including nausea, vomiting, dizziness, sedation, and delayed bowel recovery.\n\nThe purpose of this clinical trial is to investigate whether an opioid-sparing general anesthesia protocol utilizing a combination of low-dose ketamine and dexmedetomidine improves overall postoperative quality of recovery in adult patients undergoing PCNL compared with standard opioid-based anesthesia.\n\nParticipants will be randomly assigned to one of two groups:\n\n* Conventional Opioid-Based Group: Participants receive standard general anesthesia supplemented with intravenous fentanyl before induction and as needed during surgery to manage pain.\n* Ketamine-Dexmedetomidine Group: Participants receive general anesthesia combined with an initial dose and continuous low-dose intravenous infusion of ketamine and dexmedetomidine throughout the surgery.\n\nFollowing surgery, all participants will receive scheduled intravenous paracetamol, with rescue opioid pain medication (nalbuphine) available if pain levels reach a moderate-to-severe threshold.\n\nThe primary outcome of the study is the patient-reported Quality of Recovery-15 (QoR-15) score at 24 hours after surgery. Secondary outcomes include total intraoperative and postoperative opioid consumption, postoperative pain scores at rest and during movement, time to first rescue pain medication, anesthesia emergence and recovery times, incidence of postoperative nausea and vomiting, and potential side effects.",[68,69,70],"Nephrolithiasis","Postoperative Pain","Quality of Recovery",[72,73,74,75,76,77,78],"Percutaneous Nephrolithotomy","Opioid-Sparing Anesthesia","Ketamine","Dexmedetomidine","QoR-15","Multimodal General Anesthesia","Postoperative Analgesia","NOT_YET_RECRUITING","2026-09-27",{"date":82,"type":83},"2026-10-02","ACTUAL",{"date":85,"type":62},"2026-10",{"date":87,"type":62},"2027-11",{"name":5,"class":6}]