[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590022":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":52,"centralContacts":56,"locations":63,"responsibleParty":82,"collaborators":61,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":61,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":61,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":110,"overallStatus":66,"whyStopped":61,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Wonkwang University Hospital","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Sugammadex 1 mg\u002Fkg Group (S1)","EXPERIMENTAL","Participants receive 1 mg\u002Fkg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade.",[13],"Drug: Sugammadex 1 mg\u002Fkg Group",{"label":15,"type":10,"description":16,"interventionNames":17},"Sugammadex 2 mg\u002Fkg Group (S2)","Participants receive 2 mg\u002Fkg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade.",[18],"Drug: Sugammadex 2 mg\u002Fkg Group",{"label":20,"type":10,"description":21,"interventionNames":22},"Sugammadex 4 mg\u002Fkg Group (S4)","Participants receive 4 mg\u002Fkg of sugammadex intravenously for reversal of rocuronium-induced neuromuscular blockade.",[23],"Drug: Sugammadex 4 mg\u002Fkg Group",{"label":25,"type":26,"description":27,"interventionNames":28},"Pyridostigmine\u002FGlycopyrrolate Group (PG)","ACTIVE_COMPARATOR","Participants receive pyridostigmine 0.2 mg\u002Fkg and glycopyrrolate 0.01 mg\u002Fkg intravenously for reversal of rocuronium-induced neuromuscular blockade.",[29],"Drug: Pyridostigmine\u002FGlycopyrrolate Group",[31,37,42,47],{"type":32,"name":33,"description":11,"armGroupLabels":34,"otherNames":35},"DRUG","Sugammadex 1 mg\u002Fkg Group",[9],[36],"S1",{"type":32,"name":38,"description":16,"armGroupLabels":39,"otherNames":40},"Sugammadex 2 mg\u002Fkg Group",[15],[41],"S2",{"type":32,"name":43,"description":21,"armGroupLabels":44,"otherNames":45},"Sugammadex 4 mg\u002Fkg Group",[20],[46],"S4",{"type":32,"name":48,"description":27,"armGroupLabels":49,"otherNames":50},"Pyridostigmine\u002FGlycopyrrolate Group",[25],[51],"PG",[53],{"name":54,"affiliation":5,"role":55},"Cheolhyeong Lee, MD","PRINCIPAL_INVESTIGATOR",[57],{"name":58,"role":59,"phone":60,"phoneExt":61,"email":62},"Cheol Lee, MD, PhD","CONTACT","82-10-6613-1252",null,"ironyii70@gmail.com",[64],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":61,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Wonkwang University hospital","RECRUITING","Iksan","Jeonbuk-do","54538","South Korea",{"type":72,"coordinates":73},"Point",[74,75],126.95444,35.94389,{"lat":75,"lon":74},[78],{"name":79,"role":59,"phone":80,"phoneExt":61,"email":81},"Cheolhyeong LEE, MD","82-10-7736-9397","Leecheolhyeong@gmail.com",{"type":55,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":61,"oldOrganization":61},"Cheol Lee,MD,PhD,","Professor","100590022","sugammadex-induced-clenching-during-neuromuscular-blockade-reversal-100590022",false,"NCT06962007","Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal","A Prospective, Randomized, Double-Blind Study of the Incidence, Severity, and Risk Factors of Clenching Induced by Sugammadex During Neuromuscular Blockade Reversal","Inclusion Criteria:\n\n* Eligible participants are adults aged 19-70 years, American Society of Anesthesiologists (ASA) physical status I-II, undergoing elective surgery under general anesthesia with rocuronium.\n\nExclusion Criteria:\n\n* Exclusion criteria include neuromuscular disorders, renal impairment (creatinine clearance \\\u003C 30 mL\u002Fmin), history of clenching or dental disease, allergy to study drugs, or emergency surgery.",true,"ALL","19 Years","70 Years",{"count":97,"type":98},240,"ESTIMATED","INTERVENTIONAL",[101],"NA","Study Objective:\n\nThis study aims to evaluate the incidence, severity, and risk factors of sugammadex-induced mouth clenching during neuromuscular blockade (NMB) reversal in adult surgical patients.\n\nStudy Design:\n\nThis prospective, randomized, double-blind, controlled clinical trial enrolls adult patients (ASA physical status I-II, aged 19-70 years) undergoing elective surgery under general anesthesia with rocuronium. Patients will be randomized into four groups to receive either sugammadex at doses of 1 mg\u002Fkg, 2 mg\u002Fkg, or 4 mg\u002Fkg, or a combination of pyridostigmine and glycopyrrolate.\n\nPrimary Outcome:\n\nThe primary outcome is the incidence of clenching within 10 minutes after NMB reversal, assessed by clinical observation, masseter EMG, and airway pressure changes, using a novel five-grade severity scale.\n\nSecondary Outcomes:\n\nSecondary outcomes include the severity of clenching, time to TOF ratio ≥0.9, BIS values at clenching onset, complications, and identification of risk factors such as dose, sex, BIS, age, BMI, and rocuronium dose.\n\nSignificance:\n\nThis study seeks to improve perioperative safety by identifying modifiable risk factors and informing dose adjustments or alternative reversal strategies to prevent sugammadex-induced clenching, particularly in high-risk populations.",[104,105,106,107,108,109],"Neuromuscular Blockade Reversal Agent","Perioperative Complications","Anesthesia, General","Sugammadex","Monitoring, Intraoperative","Masseter Muscle Spasm",[111,112,113],"sugammadex","mouth clenching","neuromuscular blockade reversal","2026-07-02",{"date":116,"type":117},"2026-07-07","ACTUAL",{"date":119,"type":117},"2025-07-01",{"date":121,"type":98},"2026-10-14",{"name":5,"class":6},1]