[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100355531":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":55,"centralContacts":50,"locations":59,"responsibleParty":448,"collaborators":50,"id":450,"slug":451,"hasResults":452,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":50,"eligibilityCriteria":456,"healthyVolunteers":457,"sex":458,"minAge":459,"maxAge":460,"enrollmentInfo":461,"targetDuration":50,"studyType":464,"phases":465,"briefSummary":467,"conditions":468,"keywords":50,"overallStatus":470,"whyStopped":50,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":479},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,14,19,23,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A. Sugammadex 2 mg\u002Fkg","EXPERIMENTAL","Participants received a single intravenous (IV) bolus of sugammadex at 2 mg\u002Fkg for moderate NMB reversal.",[13],"Drug: Sugammadex 2 mg\u002Fkg",{"label":15,"type":10,"description":16,"interventionNames":17},"Part A. Sugammadex 4 mg\u002Fkg","Participants received a single IV bolus of sugammadex at 4 mg\u002Fkg for deep NMB reversal.",[18],"Drug: Sugammadex 4 mg\u002Fkg",{"label":20,"type":10,"description":21,"interventionNames":22},"Part B. Sugammadex 2 mg\u002Fkg","Participants received a single IV bolus of sugammadex at 2 mg\u002Fkg for moderate NMB reversal.",[13],{"label":24,"type":10,"description":16,"interventionNames":25},"Part B. Sugammadex 4 mg\u002Fkg",[18],{"label":27,"type":28,"description":29,"interventionNames":30},"Part B. Neostigmine","ACTIVE_COMPARATOR","Participants received a single IV bolus containing neostigmine (50 μg\u002Fkg; up to 5 mg maximum dose) in combination with either glycopyrrolate (10 μg\u002Fkg) or atropine sulfate (20 μg\u002Fkg) based on availability and\u002For contraindications, for moderate NMB reversal.",[31,32],"Drug: Neostigmine + Glycopyrrolate","Drug: Neostigmine + Atropine",[34,41,46,51],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DRUG","Sugammadex 2 mg\u002Fkg","For moderate NMB reversal, a single IV bolus of sugammadex (2 mg\u002Fkg) will be given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to train-of-four (TOF) stimulations.",[9,20],[40],"MK-8616",{"type":35,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Sugammadex 4 mg\u002Fkg","For deep NMB reversal, a single IV bolus of sugammadex (4 mg\u002Fkg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).",[15,24],[40],{"type":35,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Neostigmine + Glycopyrrolate","For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg\u002Fkg; up to 5 mg maximum dose) as well as glycopyrrolate (10 μg\u002Fkg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of T2 in response to TOF stimulations.",[27],null,{"type":35,"name":52,"description":53,"armGroupLabels":54,"otherNames":50},"Neostigmine + Atropine","For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg\u002Fkg; up to 5 mg maximum dose) as well as atropine (20 μg\u002Fkg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of T2 in response to TOF stimulations.",[27],[56],{"name":57,"affiliation":5,"role":58},"Medical Director","STUDY_DIRECTOR",[60,73,83,93,103,112,122,132,144,154,164,176,186,196,208,218,227,239,251,263,274,286,295,307,316,322,334,343,355,365,374,383,394,406,415,420,426,432,438],{"facility":61,"status":50,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":50},"Lucille Packard Children's Hospital ( Site 3008)","Palo Alto","California","94304","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-122.14302,37.44188,{"lat":71,"lon":70},{"facility":74,"status":50,"city":75,"state":76,"zip":77,"country":65,"countryCode":66,"cosmosGeoPoint":78,"geoPoint":82,"contacts":50},"Variety Children's Hospital D.B.A. Nicklaus Children's Hospital ( Site 3019)","Miami","Florida","33155",{"type":68,"coordinates":79},[80,81],-80.19366,25.77427,{"lat":81,"lon":80},{"facility":84,"status":50,"city":85,"state":86,"zip":87,"country":65,"countryCode":66,"cosmosGeoPoint":88,"geoPoint":92,"contacts":50},"OU Medical Center ( Site 3005)","Oklahoma City","Oklahoma","73104",{"type":68,"coordinates":89},[90,91],-97.51643,35.46756,{"lat":91,"lon":90},{"facility":94,"status":50,"city":95,"state":96,"zip":97,"country":65,"countryCode":66,"cosmosGeoPoint":98,"geoPoint":102,"contacts":50},"The Children's Hospital of Philadelphia ( Site 3021)","Philadelphia","Pennsylvania","19104",{"type":68,"coordinates":99},[100,101],-75.16362,39.95238,{"lat":101,"lon":100},{"facility":104,"status":50,"city":105,"state":96,"zip":106,"country":65,"countryCode":66,"cosmosGeoPoint":107,"geoPoint":111,"contacts":50},"Children's Hospital of Pittsburgh UPMC ( Site 3017)","Pittsburgh","15224",{"type":68,"coordinates":108},[109,110],-79.99589,40.44062,{"lat":110,"lon":109},{"facility":113,"status":50,"city":114,"state":115,"zip":116,"country":65,"countryCode":66,"cosmosGeoPoint":117,"geoPoint":121,"contacts":50},"McGovern Medical School at UT Health\u002F Memorial Hermann ( Site 3014)","Houston","Texas","77030",{"type":68,"coordinates":118},[119,120],-95.36327,29.76328,{"lat":120,"lon":119},{"facility":123,"status":50,"city":124,"state":125,"zip":126,"country":65,"countryCode":66,"cosmosGeoPoint":127,"geoPoint":131,"contacts":50},"University of Vermont Medical Center ( Site 3013)","Burlington","Vermont","05401",{"type":68,"coordinates":128},[129,130],-73.21207,44.47588,{"lat":130,"lon":129},{"facility":133,"status":50,"city":134,"state":135,"zip":136,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":143,"contacts":50},"The Children s Hospital at Westmead ( Site 3805)","Westmead","New South Wales","2145","Australia","AU",{"type":68,"coordinates":140},[141,142],150.98768,-33.80383,{"lat":142,"lon":141},{"facility":145,"status":50,"city":146,"state":147,"zip":148,"country":137,"countryCode":138,"cosmosGeoPoint":149,"geoPoint":153,"contacts":50},"Queensland Children s Hospital ( Site 3806)","South Brisbane","Queensland","4101",{"type":68,"coordinates":150},[151,152],153.02049,-27.48034,{"lat":152,"lon":151},{"facility":155,"status":50,"city":156,"state":157,"zip":158,"country":137,"countryCode":138,"cosmosGeoPoint":159,"geoPoint":163,"contacts":50},"Royal Childrens Hospital Melbourne ( Site 3801)","Parkville","Victoria","3052",{"type":68,"coordinates":160},[161,162],144.95,-37.78333,{"lat":162,"lon":161},{"facility":165,"status":50,"city":166,"state":167,"zip":168,"country":169,"countryCode":170,"cosmosGeoPoint":171,"geoPoint":175,"contacts":50},"Universitaire Ziekenhuis Antwerpen - UZA ( Site 3200)","Edegem","Antwerpen","2650","Belgium","BE",{"type":68,"coordinates":172},[173,174],4.44504,51.15662,{"lat":174,"lon":173},{"facility":177,"status":50,"city":178,"state":179,"zip":180,"country":169,"countryCode":170,"cosmosGeoPoint":181,"geoPoint":185,"contacts":50},"UZ Brussel ( Site 3201)","Brussels","Bruxelles-Capitale, Region de","1090",{"type":68,"coordinates":182},[183,184],4.34878,50.85045,{"lat":184,"lon":183},{"facility":187,"status":50,"city":188,"state":189,"zip":190,"country":169,"countryCode":170,"cosmosGeoPoint":191,"geoPoint":195,"contacts":50},"UZ Leuven - Campus Gasthuisberg ( Site 3202)","Leuven","Vlaams-Brabant","3000",{"type":68,"coordinates":192},[193,194],4.70093,50.87959,{"lat":194,"lon":193},{"facility":197,"status":50,"city":198,"state":199,"zip":200,"country":201,"countryCode":202,"cosmosGeoPoint":203,"geoPoint":207,"contacts":50},"Hospital Pequeno Principe ( Site 3826)","Curitiba","Paraná","80250-060","Brazil","BR",{"type":68,"coordinates":204},[205,206],-49.27306,-25.42778,{"lat":206,"lon":205},{"facility":209,"status":50,"city":210,"state":211,"zip":212,"country":201,"countryCode":202,"cosmosGeoPoint":213,"geoPoint":217,"contacts":50},"Hospital Tacchini ( Site 3827)","Bento Gonçalves","Rio Grande do Sul","95700-084",{"type":68,"coordinates":214},[215,216],-51.51917,-29.17139,{"lat":216,"lon":215},{"facility":219,"status":50,"city":220,"state":50,"zip":221,"country":201,"countryCode":202,"cosmosGeoPoint":222,"geoPoint":226,"contacts":50},"Instituto da Crianca do Hospital das Clinicas-FMUSP ( Site 3825)","São Paulo","05403-900",{"type":68,"coordinates":223},[224,225],-46.63611,-23.5475,{"lat":225,"lon":224},{"facility":228,"status":50,"city":229,"state":230,"zip":231,"country":232,"countryCode":233,"cosmosGeoPoint":234,"geoPoint":238,"contacts":50},"Rigshospitalet ( Site 3250)","Copenhagen","Capital Region","2100","Denmark","DK",{"type":68,"coordinates":235},[236,237],12.56553,55.67594,{"lat":237,"lon":236},{"facility":240,"status":50,"city":241,"state":242,"zip":243,"country":244,"countryCode":245,"cosmosGeoPoint":246,"geoPoint":250,"contacts":50},"New Childrens Hospital ( Site 3750)","Helsinki","Uusimaa","00029","Finland","FI",{"type":68,"coordinates":247},[248,249],24.93545,60.16952,{"lat":249,"lon":248},{"facility":252,"status":50,"city":253,"state":254,"zip":255,"country":256,"countryCode":257,"cosmosGeoPoint":258,"geoPoint":262,"contacts":50},"C.H.R.U. de Lille. Hopital Jeanne de Flandres ( Site 3304)","Lille","Nord","59000","France","FR",{"type":68,"coordinates":259},[260,261],3.05512,50.63391,{"lat":261,"lon":260},{"facility":264,"status":50,"city":265,"state":50,"zip":266,"country":267,"countryCode":268,"cosmosGeoPoint":269,"geoPoint":273,"contacts":50},"Unidad de Cirugía Cardiovascular ( Site 4126)","Guatemala City","01011","Guatemala","GT",{"type":68,"coordinates":270},[271,272],-90.51327,14.64072,{"lat":272,"lon":271},{"facility":275,"status":50,"city":276,"state":277,"zip":278,"country":279,"countryCode":280,"cosmosGeoPoint":281,"geoPoint":285,"contacts":50},"Szegedi Tudomanyegyetem ( Site 4201)","Szeged","Csongrád megye","6720","Hungary","HU",{"type":68,"coordinates":282},[283,284],20.14824,46.253,{"lat":284,"lon":283},{"facility":287,"status":50,"city":288,"state":50,"zip":289,"country":279,"countryCode":280,"cosmosGeoPoint":290,"geoPoint":294,"contacts":50},"Debreceni Egyetem Klinikai Kozpont ( Site 4200)","Debrecen","4032",{"type":68,"coordinates":291},[292,293],21.62444,47.53167,{"lat":293,"lon":292},{"facility":296,"status":50,"city":297,"state":298,"zip":299,"country":300,"countryCode":301,"cosmosGeoPoint":302,"geoPoint":306,"contacts":50},"Sarawak General Hospital ( Site 3877)","Kuching","Sarawak","93586","Malaysia","MY",{"type":68,"coordinates":303},[304,305],110.33333,1.55,{"lat":305,"lon":304},{"facility":308,"status":50,"city":309,"state":50,"zip":310,"country":300,"countryCode":301,"cosmosGeoPoint":311,"geoPoint":315,"contacts":50},"Women and Children Hospital Kuala Lumpur (Hospital Tunku Azizah) ( Site 3875)","Kuala Lumpur","50300",{"type":68,"coordinates":312},[313,314],101.68653,3.1412,{"lat":314,"lon":313},{"facility":317,"status":50,"city":309,"state":50,"zip":318,"country":300,"countryCode":301,"cosmosGeoPoint":319,"geoPoint":321,"contacts":50},"University Malaya Medical Centre. ( Site 3876)","59100",{"type":68,"coordinates":320},[313,314],{"lat":314,"lon":313},{"facility":323,"status":50,"city":324,"state":325,"zip":326,"country":327,"countryCode":328,"cosmosGeoPoint":329,"geoPoint":333,"contacts":50},"Hospital General de Zona No. 1 ( Site 4153)","Ciudad de Villa de Álvarez","Colima","28984","Mexico","MX",{"type":68,"coordinates":330},[331,332],-103.73778,19.26722,{"lat":332,"lon":331},{"facility":335,"status":50,"city":336,"state":50,"zip":337,"country":327,"countryCode":328,"cosmosGeoPoint":338,"geoPoint":342,"contacts":50},"Centenario Hospital Miguel Hidalgo-Pediatrics Department ( Site 4152)","Aguascalientes","20259",{"type":68,"coordinates":339},[340,341],-102.2843,21.88262,{"lat":341,"lon":340},{"facility":344,"status":50,"city":345,"state":346,"zip":347,"country":348,"countryCode":349,"cosmosGeoPoint":350,"geoPoint":354,"contacts":50},"Radboud University Medical Center ( Site 4226)","Nijmegen","Gelderland","6525 GA","Netherlands","NL",{"type":68,"coordinates":351},[352,353],5.85278,51.8425,{"lat":353,"lon":352},{"facility":356,"status":50,"city":357,"state":358,"zip":359,"country":348,"countryCode":349,"cosmosGeoPoint":360,"geoPoint":364,"contacts":50},"Erasmus University Medical Center ( Site 4225)","Rotterdam","South Holland","3015 GD",{"type":68,"coordinates":361},[362,363],4.47917,51.9225,{"lat":363,"lon":362},{"facility":366,"status":50,"city":367,"state":50,"zip":368,"country":348,"countryCode":349,"cosmosGeoPoint":369,"geoPoint":373,"contacts":50},"University Medical Center Groningen ( Site 4227)","Groningen","9713 GZ",{"type":68,"coordinates":370},[371,372],6.56667,53.21917,{"lat":372,"lon":371},{"facility":375,"status":50,"city":376,"state":50,"zip":377,"country":348,"countryCode":349,"cosmosGeoPoint":378,"geoPoint":382,"contacts":50},"Wilhelmina Kinderziekenhuis ( Site 4228)","Utrecht","3584 EA",{"type":68,"coordinates":379},[380,381],5.12222,52.09083,{"lat":381,"lon":380},{"facility":384,"status":50,"city":385,"state":50,"zip":386,"country":387,"countryCode":388,"cosmosGeoPoint":389,"geoPoint":393,"contacts":50},"Instituto Nacional Cardiovascular Incor ( Site 3928)","Lima","15072","Peru","PE",{"type":68,"coordinates":390},[391,392],-77.02824,-12.04318,{"lat":392,"lon":391},{"facility":395,"status":50,"city":396,"state":397,"zip":398,"country":399,"countryCode":400,"cosmosGeoPoint":401,"geoPoint":405,"contacts":50},"Scientific Research Institute Complex Problems Cardiovascular Disease ( Site 4288)","Kemerovo","Kemerovo Oblast","650002","Russia","RU",{"type":68,"coordinates":402},[403,404],86.10435,55.35417,{"lat":404,"lon":403},{"facility":407,"status":50,"city":408,"state":408,"zip":409,"country":399,"countryCode":400,"cosmosGeoPoint":410,"geoPoint":414,"contacts":50},"NMRC Obstetrics Gynecology and Perinatology n.a. V.I. Kulakov ( Site 4287)","Moscow","117997",{"type":68,"coordinates":411},[412,413],37.61781,55.75204,{"lat":413,"lon":412},{"facility":416,"status":50,"city":408,"state":408,"zip":409,"country":399,"countryCode":400,"cosmosGeoPoint":417,"geoPoint":419,"contacts":50},"Pediatric Hematology Oncology and Immunology Centre n.a. D.Rogachev. ( Site 4275)",{"type":68,"coordinates":418},[412,413],{"lat":413,"lon":412},{"facility":421,"status":50,"city":408,"state":408,"zip":422,"country":399,"countryCode":400,"cosmosGeoPoint":423,"geoPoint":425,"contacts":50},"Children City Clinical Hospital 13 n.a N.F.Filatov ( Site 4285)","123001",{"type":68,"coordinates":424},[412,413],{"lat":413,"lon":412},{"facility":427,"status":50,"city":408,"state":408,"zip":428,"country":399,"countryCode":400,"cosmosGeoPoint":429,"geoPoint":431,"contacts":50},"Children City Clinical Hospital #9 n.a. G.N.Speransky ( Site 4290)","123317",{"type":68,"coordinates":430},[412,413],{"lat":413,"lon":412},{"facility":433,"status":50,"city":408,"state":408,"zip":434,"country":399,"countryCode":400,"cosmosGeoPoint":435,"geoPoint":437,"contacts":50},"Scientific-Research Clinical Pediatric Institution n.a. Veltischev ( Site 4276)","125412",{"type":68,"coordinates":436},[412,413],{"lat":413,"lon":412},{"facility":439,"status":50,"city":440,"state":441,"zip":442,"country":399,"countryCode":400,"cosmosGeoPoint":443,"geoPoint":447,"contacts":50},"St.Petersburg State Pediatric Medical University ( Site 4281)","Saint Petersburg","Sankt-Peterburg","194100",{"type":68,"coordinates":444},[445,446],30.31413,59.93863,{"lat":446,"lon":445},{"type":449,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100355531","phase-4-efficacy-safety-and-pharmacokinetics-of-sugammadex-mk-8616-for-reversal-of-neuromuscular-blockade-in-pediatric-participants-aged-birth-to-2-years-mk-8616-169-100355531",true,"NCT03909165","Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to \u003C2 Years (MK-8616-169)","A Phase 4 Double-blinded, Randomized, Active Comparator-controlled Clinical Trial to Study the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to \u003C2 Years","Inclusion Criteria:\n\n* Categorized as American Society of Anesthesiologists (ASA) Physical Status Class 1, 2, or 3.\n* Has a planned non-emergent surgical procedure or clinical situation (e.g., intubation) that requires moderate or deep NMB with either rocuronium or vecuronium.\n* Has a surgical procedure or clinical situation that would allow neuromuscular monitoring techniques to be applied for neuromuscular transmission monitoring.\n* Is male or female, between birth and \\\u003C2 years of age.\n\nExclusion Criteria:\n\n* Is a preterm infant or neonate \\\u003C36 weeks gestational age at birth.\n* Has any clinically significant condition or situation (e.g., anatomical malformation that complicates intubation) other than the condition requiring the use of NMBA that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.\n* Has a neuromuscular disorder that may affect NMB and\u002For trial assessments.\n* Is dialysis-dependent or has (or is suspected of having) severe renal insufficiency.\n* Has or is suspected of having a family or personal history of malignant hyperthermia.\n* Has or is suspected of having an allergy to study treatments or its\u002Ftheir excipients, to opioids\u002Fopiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia.\n* Is expected to require mechanical ventilation after the procedure.\n* Has received or is planned to receive toremifene and\u002For fusidic acid via IV administration within 24 hours before or within 24 hours after administration of study treatment.\n* Use of medication expected to interfere with study treatments given in this trial.\n* Has been previously treated with sugammadex or has participated in a sugammadex clinical trial within 30 days of signing the informed consent form of this current trial.\n* Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing the informed consent\u002Fassent for this current trial.",false,"ALL","1 Day","2 Years",{"count":462,"type":463},145,"ACTUAL","INTERVENTIONAL",[466],"PHASE4","This study will evaluate the efficacy, safety, and pharmacokinetics (PK) of sugammadex (MK-8616) for reversal of both moderate and deep neuromuscular blockade (NMB) in pediatric participants aged birth to \\\u003C2 years. The primary hypothesis of this study is that sugammadex is superior to neostigmine in reversing moderate NMB as measured by time to neuromuscular recovery.",[469],"Neuromuscular Blockade","COMPLETED","2025-07-08",{"date":473,"type":463},"2025-07-25",{"date":475,"type":463},"2019-07-23",{"date":477,"type":463},"2023-09-21",{"name":5,"class":6},39]