[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636452":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":44,"responsibleParty":63,"collaborators":26,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":26,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":93,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Arm: Methadone-Based Anesthesia","EXPERIMENTAL","Intervention: Drug: Methadone\n\nIntravenous methadone 0.25 mg\u002Fkg (ideal body weight) administered at induction Optional supplemental dose (2 mg) at emergence if clinically indicated Additional intraoperative short-acting opioids discouraged",[13],"Drug: Intravenous Methadone",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Comparator Arm: Standard Opioid-Based Anesthesia","ACTIVE_COMPARATOR","Intervention: Drug: Short-acting opioids\n\nFentanyl and\u002For hydromorphone administered intraoperatively according to clinician judgment Reflects usual care practice",[19],"Drug: Short-acting Opioids Intraoperative analgesia",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Intravenous Methadone","Intervention Description - Intravenous Methadone\n\nA single intravenous dose of methadone (0.25 mg\u002Fkg based on ideal body weight) administered at induction of anesthesia to provide sustained intraoperative and early postoperative analgesia. Additional short-acting opioids are discouraged but may be administered if clinically required. A supplemental dose of methadone (2 mg) may be given at emergence in case of significant nociceptive signs.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Short-acting Opioids Intraoperative analgesia","ntervention Description - Short-acting Opioids\n\nIntraoperative analgesia using short-acting opioids (e.g., fentanyl and\u002For hydromorphone) administered at induction and throughout surgery according to clinician judgment and institutional practice. This approach reflects usual care, with dosing and timing determined pragmatically based on intraoperative needs.",[15],[32,35],{"name":33,"affiliation":5,"role":34},"Joseph Szokol, MD PhD","STUDY_DIRECTOR",{"name":36,"affiliation":37,"role":34},"EVAN KARASCH, MD PhD","DUKE",[39],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"alexandre JOOSTEN, MD PhD","CONTACT","+13109627337","AJOOSTEN@MEDNET.UCLA.EDU",[45],{"facility":46,"status":26,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"UCI","Irvine","California","92697","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-117.82311,33.66946,{"lat":56,"lon":55},[59],{"name":60,"role":41,"phone":61,"phoneExt":26,"email":62},"SEAN COECKELENBERGH, MD PhD","+19496788922","scoeckel@hs.uci.edu",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Alexandre P. Joosten","PI","100636452","phase-3-methadone-for-enhanced-postoperative-analgesia-in-intermediate-risk-noncardiac-surgery-melody-100636452",false,"NCT07565870","Methadone for Enhanced Postoperative Analgesia in Intermediate-Risk Noncardiac Surgery (MELODY)","Methadone for Enhanced Postoperative Analgesia in Intermediate-Risk Noncardiac Surgery: A Multicentre Randomized Controlled Trial (MELODY Trial)","MELODY","Inclusion Criteria\n\n* Age ≥18 years\n* Elective intermediate-risk noncardiac surgery under general anesthesia\n* ASA physical status I-III\n* Expected hospital stay ≥24 hours\n* Ability to provide informed consent\n\nExclusion Criteria\n\n* Severe hepatic dysfunction (Child-Pugh C)\n* Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²)\n* Known allergy to methadone or opioids\n* Pregnancy or breastfeeding\n* Chronic opioid use or opioid use disorder\n* Planned use of epidural or regional analgesia\n* Inability to complete study assessments","ALL","18 Years",{"count":78,"type":79},400,"ESTIMATED","INTERVENTIONAL",[82],"PHASE3","Postoperative pain control remains suboptimal for a large proportion of surgical patients and is frequently associated with slower recovery and higher reliance on opioids after surgery. Current intraoperative analgesic approaches predominantly use short-acting opioids, whose rapid pharmacokinetics can lead to variable drug exposure and inconsistent control of nociceptive stimuli.\n\nMethadone has a different pharmacologic profile, combining prolonged μ-opioid receptor activity with N-methyl-D-aspartate receptor antagonism, allowing sustained analgesia following a single intraoperative administration and potentially enhancing postoperative recovery.\n\nThe MELODY trial is a multicentre, randomized, patient-blinded clinical study designed to compare a single intravenous dose of methadone given at induction with conventional short-acting opioid-based anesthesia in adults undergoing intermediate-risk noncardiac surgery. The primary aim is to evaluate whether this strategy leads to improved quality of recovery on the first postoperative day.",[85,86],"Postoperative Pain","Recovery",[88,89,90,91,92],"Methadone","QoR-15","Quality of Recovery","Multimodal Analgesia","General Anesthesia","NOT_YET_RECRUITING","2026-04-29",{"date":96,"type":97},"2026-05-04","ACTUAL",{"date":99,"type":79},"2026-07-01",{"date":101,"type":79},"2027-03-30",{"name":65,"class":6},1]