[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100093332":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":37,"locations":37,"responsibleParty":38,"collaborators":37,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":37,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":49,"maxAge":37,"enrollmentInfo":50,"targetDuration":37,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":37,"overallStatus":59,"whyStopped":37,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":37},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Rocuronium + Sugammadex 2.0 mg\u002Fkg","EXPERIMENTAL","After the IV intubation dose (0.6 mg\u002Fkg) or last maintenance dose (0.15 mg\u002Fkg) of rocuronium, at reappearance of T2, participants will receive IV sugammadex 2.0 mg\u002Fkg.",[13,14],"Drug: Sugammadex","Drug: Rocuronium",{"label":16,"type":10,"description":17,"interventionNames":18},"Rocuronium + Sugammadex 4.0 mg\u002Fkg","After the IV intubation dose (0.6 mg\u002Fkg) or last maintenance dose (0.15 mg\u002Fkg) of rocuronium, at reappearance of T2, participants will receive IV sugammadex 4.0 mg\u002Fkg.",[13,14],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Sugammadex","Sugammadex solution for injection.",[9,16],[26],"Org 25969, MK-8616, Bridion®",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Rocuronium","Rocuronium bromide solution for injection.",[9,16],[32],"Zemuron®",[34],{"name":35,"affiliation":5,"role":36},"Medical Director","STUDY_DIRECTOR",null,{"type":39,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100093332","phase-3-safety-and-efficacy-of-sugammadex-org-25969-mk-8616-in-participants-with-or-having-a-past-history-of-pulmonary-disease-194308-p05932-mk-8616-017-100093332",true,"NCT00475215","Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017)","A Multicenter, Randomized, Parallel Group, Comparative, Safety-Assessor Blinded, Phase IIIa Trial in Adult Surgical Subjects Under General Anesthesia at Increased Risk for Pulmonary Complications","Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) Class 1 to 3;\n* Has been diagnosed with or having a past history of pulmonary disease;\n* Is scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block with the use of rocuronium;\n* Is scheduled for surgery in supine position;\n* Has given written informed consent;\n\nExclusion Criteria:\n\n* Is expected to have a difficult intubation due to anatomical malformations;\n* Has known or suspected of having neuromuscular disorders impairing neuromuscular blockade and\u002For significant renal dysfunction;\n* Has known or suspected of having a (family) history of malignant hyperthermia;\n* Has known or suspected of having an allergy to narcotics, muscle relaxants or other medications used during surgery;\n* Is receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+;\n* Is a female who is pregnant or breast-feeding;\n* Is a female of childbearing potential not using an acceptable method of birth control \\[condom or diaphragm with spermicide, vasectomized partner (\\> 6 months), IUD, abstinence\\] or using only hormonal contraception as birth control;\n* Has already participated in a sugammadex trial including Protocol 19.4.308;\n* Has participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.308.",false,"ALL","18 Years",{"count":51,"type":52},86,"ACTUAL","INTERVENTIONAL",[55],"PHASE3","The purpose of the trial is to research the safety and to show faster recovery after administration of 2.0 mg\u002Fkg or 4.0 mg\u002Fkg sugammadex (Org 25969, MK-8616) given as a reversal agent for 0.6 mg\u002Fkg (0.15 mg\u002Fkg maintenance dose) rocuronium (Zemuron®) in participants diagnosed with or having a history of pulmonary disease. All drug administration will be via the intravenous (IV) route.",[58],"Anesthesia, General","COMPLETED","2019-04-10",{"date":62,"type":52},"2019-04-12",{"date":64,"type":52},"2005-10-27",{"date":66,"type":52},"2006-09-09",{"name":5,"class":6}]