[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100312332":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":64,"centralContacts":59,"locations":68,"responsibleParty":299,"collaborators":59,"id":301,"slug":302,"hasResults":303,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":59,"eligibilityCriteria":307,"healthyVolunteers":308,"sex":309,"minAge":310,"maxAge":59,"enrollmentInfo":311,"targetDuration":59,"studyType":314,"phases":315,"briefSummary":317,"conditions":318,"keywords":59,"overallStatus":320,"whyStopped":59,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":329},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,15,20,25,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Sugammadex 2 mg\u002Fkg ABW","EXPERIMENTAL","Following administration of NMBA, participants received a single intravenous (i.v.) bolus of Sugammadex at 2 mg\u002Fkg as determined utilizing participant ABW. A treatment dose of 2 mg\u002Fkg was used for reversal of moderate NMB.",[13,14],"Drug: Sugammadex 2 mg\u002Fkg ABW","Drug: Rocuronium or Vecuronium",{"label":16,"type":10,"description":17,"interventionNames":18},"Sugammadex 2 mg\u002Fkg IBW","Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg\u002Fkg as determined utilizing participant IBW. A treatment dose of 2 mg\u002Fkg was used for reversal of moderate NMB.",[19,14],"Drug: Sugammadex 2 mg\u002Fkg IBW",{"label":21,"type":10,"description":22,"interventionNames":23},"Sugammadex 4 mg\u002Fkg ABW","Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg\u002Fkg as determined utilizing participant ABW. A treatment dose of 4 mg\u002Fkg was used for reversal of deep NMB.",[24,14],"Drug: Sugammadex 4 mg\u002Fkg ABW",{"label":26,"type":10,"description":27,"interventionNames":28},"Sugammadex 4 mg\u002Fkg IBW","Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg\u002Fkg as determined utilizing participant IBW. A treatment dose of 4 mg\u002Fkg was used for reversal of deep NMB.",[29,14],"Drug: Sugammadex 4 mg\u002Fkg IBW",{"label":31,"type":32,"description":33,"interventionNames":34},"Neostigmine\u002FGlycopyrrolate","ACTIVE_COMPARATOR","Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg\u002Fkg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg\u002Fkg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine\u002FGlycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available.",[35,14],"Drug: Neostigmine + Glycopyrrolate",[37,43,47,51,55,60],{"type":38,"name":9,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex (2 mg\u002Fkg by ABW) for reversal of moderate NMB.\n\nModerate NMB is defined as the reappearance of a second twitch (T2) in response to TOF stimulations.",[9],[42],"MK-8616",{"type":38,"name":16,"description":44,"armGroupLabels":45,"otherNames":46},"Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex (2 mg\u002Fkg by IBW) for reversal of moderate NMB.\n\nModerate NMB is defined as the reappearance of T2 in response to TOF stimulations.",[16],[42],{"type":38,"name":21,"description":48,"armGroupLabels":49,"otherNames":50},"Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex (4 mg\u002Fkg by ABW) for reversal of deep NMB.\n\nDeep NMB is defined as no response to TOF stimulations (TOF=0) and a detection target of 1-2 post-tetanic counts (PTCs).",[21],[42],{"type":38,"name":26,"description":52,"armGroupLabels":53,"otherNames":54},"Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants will receive a single i.v. bolus of Sugammadex (4 mg\u002Fkg by IBW) for reversal of deep NMB.\n\nDeep NMB is defined as no response to TOF stimulations (TOF=0) and a detection target of 1-2 post-tetanic counts (PTCs).",[26],[42],{"type":38,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Neostigmine + Glycopyrrolate","Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Neostigmine (50 µg\u002Fkg; 5 mg maximum) and Glycopyrrolate (10 µg\u002Fkg; 1 mg maximum), dosed according to participant ABW for reversal of moderate NMB.\n\nModerate NMB is defined as the reappearance of T2 in response to TOF stimulations.",[31],null,{"type":38,"name":61,"description":62,"armGroupLabels":63,"otherNames":59},"Rocuronium or Vecuronium","To achieve NMB, participants received steroidal NMBA Rocuronium Bromide or Vecuronium Bromide administered via i.v. infusion and dosed according to participant ABW. NMBAs were concomitant medications used per label as adjunct to general anesthesia.",[31,9,16,21,26],[65],{"name":66,"affiliation":5,"role":67},"Medical Director","STUDY_DIRECTOR",[69,82,92,102,112,122,132,142,152,162,172,182,187,197,208,219,230,234,245,254,263,272,281,290],{"facility":70,"status":59,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":59},"University California \u002F Davis ( Site 2001)","Sacramento","California","95817","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-121.4944,38.58157,{"lat":80,"lon":79},{"facility":83,"status":59,"city":84,"state":85,"zip":86,"country":74,"countryCode":75,"cosmosGeoPoint":87,"geoPoint":91,"contacts":59},"Jackson Memorial Hospital\u002FUniversity of Miami ( Site 2007)","Miami","Florida","33136",{"type":77,"coordinates":88},[89,90],-80.19366,25.77427,{"lat":90,"lon":89},{"facility":93,"status":59,"city":94,"state":95,"zip":96,"country":74,"countryCode":75,"cosmosGeoPoint":97,"geoPoint":101,"contacts":59},"University of Kansas Medical Center ( Site 2049)","Kansas City","Kansas","66160",{"type":77,"coordinates":98},[99,100],-94.62746,39.11417,{"lat":100,"lon":99},{"facility":103,"status":59,"city":104,"state":105,"zip":106,"country":74,"countryCode":75,"cosmosGeoPoint":107,"geoPoint":111,"contacts":59},"William Beaumont Hospital - Royal Oak ( Site 2033)","Royal Oak","Michigan","48073",{"type":77,"coordinates":108},[109,110],-83.14465,42.48948,{"lat":110,"lon":109},{"facility":113,"status":59,"city":114,"state":115,"zip":116,"country":74,"countryCode":75,"cosmosGeoPoint":117,"geoPoint":121,"contacts":59},"University Hospital- Columbia MO ( Site 2060)","Columbia","Missouri","65212",{"type":77,"coordinates":118},[119,120],-92.33407,38.95171,{"lat":120,"lon":119},{"facility":123,"status":59,"city":124,"state":125,"zip":126,"country":74,"countryCode":75,"cosmosGeoPoint":127,"geoPoint":131,"contacts":59},"Robert Wood Johnson University Hospital ( Site 2037)","New Brunswick","New Jersey","08901",{"type":77,"coordinates":128},[129,130],-74.45182,40.48622,{"lat":130,"lon":129},{"facility":133,"status":59,"city":134,"state":135,"zip":136,"country":74,"countryCode":75,"cosmosGeoPoint":137,"geoPoint":141,"contacts":59},"Mission Hospital - St. Joseph ( Site 2015)","Asheville","North Carolina","28801",{"type":77,"coordinates":138},[139,140],-82.55402,35.60095,{"lat":140,"lon":139},{"facility":143,"status":59,"city":144,"state":145,"zip":146,"country":74,"countryCode":75,"cosmosGeoPoint":147,"geoPoint":151,"contacts":59},"Cleveland Clinic Foundation ( Site 2031)","Cleveland","Ohio","44195",{"type":77,"coordinates":148},[149,150],-81.69541,41.4995,{"lat":150,"lon":149},{"facility":153,"status":59,"city":154,"state":155,"zip":156,"country":74,"countryCode":75,"cosmosGeoPoint":157,"geoPoint":161,"contacts":59},"Temple University Hospital ( Site 2004)","Philadelphia","Pennsylvania","19140",{"type":77,"coordinates":158},[159,160],-75.16362,39.95238,{"lat":160,"lon":159},{"facility":163,"status":59,"city":164,"state":165,"zip":166,"country":74,"countryCode":75,"cosmosGeoPoint":167,"geoPoint":171,"contacts":59},"Vanderbilt University Medical Center ( Site 2032)","Nashville","Tennessee","37232",{"type":77,"coordinates":168},[169,170],-86.78444,36.16589,{"lat":170,"lon":169},{"facility":173,"status":59,"city":174,"state":175,"zip":176,"country":74,"countryCode":75,"cosmosGeoPoint":177,"geoPoint":181,"contacts":59},"Hermann Drive Surgical Center ( Site 2020)","Houston","Texas","77004",{"type":77,"coordinates":178},[179,180],-95.36327,29.76328,{"lat":180,"lon":179},{"facility":183,"status":59,"city":174,"state":175,"zip":176,"country":74,"countryCode":75,"cosmosGeoPoint":184,"geoPoint":186,"contacts":59},"Hermann Drive Surgical Center ( Site 2059)",{"type":77,"coordinates":185},[179,180],{"lat":180,"lon":179},{"facility":188,"status":59,"city":189,"state":190,"zip":191,"country":74,"countryCode":75,"cosmosGeoPoint":192,"geoPoint":196,"contacts":59},"Zablocki VA Medical Center ( Site 2011)","Milwaukee","Wisconsin","53295",{"type":77,"coordinates":193},[194,195],-87.90647,43.0389,{"lat":195,"lon":194},{"facility":198,"status":59,"city":199,"state":59,"zip":200,"country":201,"countryCode":202,"cosmosGeoPoint":203,"geoPoint":207,"contacts":59},"Sozialmedizinisches Zentrum Ost - Donauspital ( Site 2150)","Vienna","1220","Austria","AT",{"type":77,"coordinates":204},[205,206],16.37208,48.20849,{"lat":206,"lon":205},{"facility":209,"status":59,"city":210,"state":59,"zip":211,"country":212,"countryCode":213,"cosmosGeoPoint":214,"geoPoint":218,"contacts":59},"Universitaire Ziekenhuis Antwerpen - UZA ( Site 2200)","Edegem","2650","Belgium","BE",{"type":77,"coordinates":215},[216,217],4.44504,51.15662,{"lat":217,"lon":216},{"facility":220,"status":59,"city":221,"state":59,"zip":222,"country":223,"countryCode":224,"cosmosGeoPoint":225,"geoPoint":229,"contacts":59},"Rigshospitalet ( Site 2253)","Copenhagen","2100","Denmark","DK",{"type":77,"coordinates":226},[227,228],12.56553,55.67594,{"lat":228,"lon":227},{"facility":231,"status":59,"city":232,"state":59,"zip":233,"country":223,"countryCode":224,"cosmosGeoPoint":59,"geoPoint":59,"contacts":59},"Bispebjerg og Frederiksberg Hospital ( Site 2250)","Copenhagen NV","2400",{"facility":235,"status":59,"city":236,"state":59,"zip":237,"country":238,"countryCode":239,"cosmosGeoPoint":240,"geoPoint":244,"contacts":59},"Johanniter Krankenhaus Bonn ( Site 2353)","Bonn","53113","Germany","DE",{"type":77,"coordinates":241},[242,243],7.09549,50.73438,{"lat":243,"lon":242},{"facility":246,"status":59,"city":247,"state":59,"zip":248,"country":238,"countryCode":239,"cosmosGeoPoint":249,"geoPoint":253,"contacts":59},"Diakovere Annastift gGmbH ( Site 2355)","Hanover","30625",{"type":77,"coordinates":250},[251,252],9.73322,52.37052,{"lat":252,"lon":251},{"facility":255,"status":59,"city":256,"state":59,"zip":257,"country":238,"countryCode":239,"cosmosGeoPoint":258,"geoPoint":262,"contacts":59},"Universitatsklinikum Giessen und Marburg GmbH ( Site 2356)","Marburg","35043",{"type":77,"coordinates":259},[260,261],8.77069,50.80904,{"lat":261,"lon":260},{"facility":264,"status":59,"city":265,"state":59,"zip":266,"country":238,"countryCode":239,"cosmosGeoPoint":267,"geoPoint":271,"contacts":59},"Klinikum Rechts der Isar Technische Universitaet Muenchen ( Site 2350)","München","81675",{"type":77,"coordinates":268},[269,270],13.31243,51.60698,{"lat":270,"lon":269},{"facility":273,"status":59,"city":274,"state":59,"zip":275,"country":238,"countryCode":239,"cosmosGeoPoint":276,"geoPoint":280,"contacts":59},"St. Franziskus-Hospital ( Site 2354)","Münster","48145",{"type":77,"coordinates":277},[278,279],7.62571,51.96236,{"lat":279,"lon":278},{"facility":282,"status":59,"city":283,"state":59,"zip":284,"country":238,"countryCode":239,"cosmosGeoPoint":285,"geoPoint":289,"contacts":59},"Klinikum am Steinenberg Reutlingen ( Site 2352)","Reutlingen","72764",{"type":77,"coordinates":286},[287,288],9.20427,48.49144,{"lat":288,"lon":287},{"facility":291,"status":59,"city":292,"state":59,"zip":293,"country":238,"countryCode":239,"cosmosGeoPoint":294,"geoPoint":298,"contacts":59},"Josephs-Hospitals Warendorf ( Site 2351)","Warendorf","48231",{"type":77,"coordinates":295},[296,297],7.98756,51.95109,{"lat":297,"lon":296},{"type":300,"investigatorFullName":59,"investigatorTitle":59,"investigatorAffiliation":59,"oldNameTitle":59,"oldOrganization":59},"SPONSOR","100312332","phase-4-efficacy-and-safety-of-sugammadex-dosed-according-to-actual-body-weight-abw-or-ideal-body-weight-ibw-in-reversal-of-neuromuscular-blockade-nmb-in-morbidly-obese-participants-mk-8616-146-100312332",true,"NCT03346070","Efficacy and Safety of Sugammadex Dosed According to Actual Body Weight (ABW) or Ideal Body Weight (IBW) in Reversal of Neuromuscular Blockade (NMB) in Morbidly Obese Participants (MK-8616-146)","A Phase 4 Randomized, Active-Comparator Controlled Trial to Study the Efficacy and Safety of Sugammadex (MK-8616) for the Reversal of Neuromuscular Blockade Induced by Either Rocuronium Bromide or Vecuronium Bromide in Morbidly Obese Subjects","Inclusion Criteria:\n\n* Have BMI ≥40 kg\u002Fm² (morbidly obese).\n* Be categorized as American Society of Anesthesiologists (ASA) Physical Status Class 3\n* Have a planned surgical procedure that requires neuromuscular block with either rocuronium or vecuronium.\n* Have a planned surgical procedure (e.g., gastrointestinal, urologic, or laparoscopic procedures) that in the opinion of the investigator does not preclude maintenance of moderate or deep depth of NMB throughout the case (maintained by re-dosing or continuous infusion).\n* Have a planned surgical procedure that would allow objective neuromuscular monitoring techniques to be applied with access to the arm for neuromuscular transmission monitoring.\n* If female, who is not of reproductive potential, be one of the following: 1) postmenopausal (defined as at least 12 months with no menses in women ≥45 years of age; 2) has had a hysterectomy and\u002For bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation\u002Focclusion at least 6 weeks prior to screening; 3) has a congenital or acquired condition that prevents childbearing; or 4) is undergoing surgical sterilization as the planned surgical procedure associated with participation in this study (e.g., hysterectomy or tubal ligation).\n* If female, who is sexually active and of child-bearing potential, agrees to use a medically accepted method of contraception through seven days after receiving protocol-specified medication. Please note the following: 1) Medically accepted methods of contraception include condoms (male or female) with a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), inert or copper-containing IUD, surgical sterilization (e.g., hysterectomy or tubal ligation); 2) Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and Human Subjects Protection Review Boards; 3 Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception; 4) If a contraceptive method listed above is restricted by local regulations\u002Fguidelines, then it does not qualify as an acceptable method of contraception for subjects participating at sites in this country\u002Fregion.\n* Be able to provide (or the subject's legally authorized representative in accordance with local requirements), written informed consent for the trial. The participant or legally authorized representative may also provide consent for Future Biomedical Research.\n\nExclusion Criteria:\n\n* Have an actual body weight \\\u003C100 kg.\n* Have a pacemaker or automatic implantable cardioverter-defibrillator that precludes the assessment of bradycardia or arrhythmias.\n* Have a medical condition or surgical procedure that precludes reversal of neuromuscular block at the end of surgery.\n* Have neuromuscular disorder(s) that may affect neuromuscular block and\u002For trial assessments.\n* Are dialysis-dependent or have severe renal insufficiency (defined as estimated creatinine clearance of \\\u003C30 mL\u002Fmin.).\n* Have or are suspected of having a personal history or family history (parents, grandparents, or siblings) of malignant hyperthermia.\n* Have or are suspected of having an allergy (e.g., hypersensitivity and\u002For anaphylactic reaction) to study treatments or its\u002Ftheir excipients, to opioids\u002Fopiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia.\n* Have received or are planning to receive toremifene within 24 hours before or within 24 hours after study medication administration.\n* Have any condition that would contraindicate the administration of study medication.\n* Are currently pregnant, attempting to become pregnant, or lactating.\n* Have any clinically significant condition or situation (e.g., anatomical malformation that complicates intubation) other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.\n* Are currently participating in or has participated in an interventional clinical trial with an investigational compound (including any other current or ongoing trial with a Sugammadex treatment arm) or device within 30 days of signing the informed consent form of this current trial.",false,"ALL","18 Years",{"count":312,"type":313},207,"ACTUAL","INTERVENTIONAL",[316],"PHASE4","The purpose of this trial is to evaluate the safety and efficacy of Sugammadex when administered according to actual body weight (ABW) as compared to ideal body weight (IBW) for the reversal of both moderate and deep neuromuscular blockade (NMB) induced by either Rocuronium or Vecuronium in morbidly obese participants. The primary hypothesis of this investigation is that, compared to obese participants dosed based on IBW, obese participants receiving Sugammadex according to ABW will demonstrate a faster time to recovery to a Train Of Four (TOF) ratio of ≥0.9 (i.e. faster NMB reversal), pooled across NMB depth and type of neuromuscular blocking agent (NMBA; Rocuronium or Vecuronium) administered.",[319],"Neuromuscular Blockade","COMPLETED","2021-01-12",{"date":323,"type":313},"2021-01-28",{"date":325,"type":313},"2018-01-01",{"date":327,"type":313},"2019-01-29",{"name":5,"class":6},24]