[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577142":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":57,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":26,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Universitas Padjadjaran","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sugammadex","EXPERIMENTAL","The subjects in this study were patients underwent laparoscopic cholecystectomy surgery with general anesthesia and muscle relaxant Rocuronium.\n\nAt the end of the surgery, thirty patients will be administered Sugammadex 1 mg\u002Fkg as a reversal agent. All patient will receive same anesthetic drug. Patients will be monitored with acceleromyography monitoring tools. Extubation was performed when the Train of Four monitor reached a Train of Four Ratio ≥ 90%.",[13],"Drug: Sugammadex 1 mg\u002Fkg",{"label":15,"type":16,"description":17,"interventionNames":18},"Neostigmine","ACTIVE_COMPARATOR","The subjects in this study were patients underwent laparoscopic cholecystectomy surgery with general anesthesia and muscle relaxant rocuronium.\n\nAt the end of the surgery, thirty patients will be administered Neostigmine 60 mcg\u002Fkg along with 0.4 mg of atropine sulfate per 1 mg of neostigmine as a reversal agent. All patient will receive same anesthetic drug. Patients will be monitored with acceleromyography monitoring tools. Extubation was performed when the Train of Four monitor reached a Train of Four Ratio ≥ 90%.",[19],"Drug: Neostigmine + Atropine",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Sugammadex 1 mg\u002Fkg","Patient in experimental arms will receive i.v. sugammadex 1 mg\u002Fkg at the end of operating procedure from the point at which a Train-of-Four Count (TOFC) of 2 is observed",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Neostigmine + Atropine","Patient in active comparators arms will receive i.v. neostigmine 60 mcg\u002Fkg along with 0.4 mg of atropine sulfate per 1 mg of neostigmine at the end of operating procedure from the point at which a Train-of-Four Count (TOFC) of 2 is observed",[15],[32],{"name":33,"affiliation":34,"role":35},"Tini T Maskoen, M.D.","Faculty of Medicine Universitas Padjadjaran","STUDY_CHAIR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Rivan P Rivan Putra Afewa, M.D., M.D.","CONTACT","+6285316832464","rivan.chaniago@gmail.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":26},"Hasan Sadikin General Hospital","RECRUITING","Bandung","West Java","40161","Indonesia","ID",{"type":52,"coordinates":53},"Point",[54,55],107.60694,-6.92222,{"lat":55,"lon":54},{"type":58,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100577142","phase-1-recovery-times-of-half-dose-sugammadex-and-neostigmine-for-rocuronium-induced-neuromuscular-blockade-100577142",false,"NCT06794450","Recovery Times of Half Dose Sugammadex and Neostigmine for Rocuronium-induced Neuromuscular Blockade","Comparison of Recovery Times Between 1 mg\u002Fkg Sugammadex and 60 mcg\u002Fkg Neostigmine for Moderate Neuromuscular Blockade Induced by Rocuronium in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients who underwent laparoscopic cholecystectomy under general anesthesia\n* Using muscle relaxant rocuronium\n* Aged 18-59 years\n* American Society of Anesthesiologists (ASA) physical status classification of 1 or 2.\n\nExclusion Criteria:\n\n* History of drug allergies to the agents used\n* Renal dysfunction\n* Musculoskeletal disorders\n* Central nervous system disorders\n* Difficult airways requiring intubation without the use of muscle relaxants.","ALL","18 Years","59 Years",{"count":70,"type":71},60,"ESTIMATED","INTERVENTIONAL",[74,75],"PHASE1","PHASE2","In operating procedure with general anesthesia muscle relaxant is usually used to increase success rate of the operation and to give better outcome. The use of reversal drugs aims to reduce the risk of post-operative complications due to muscle relaxants. Neostigmine is commonly used as a reversal drug, but its indirect mechanism of action results in a long and unpredictable recovery time. Sugammadex directly bind and inactivate rocuronium, in which resulting in a faster and predictable recovery time. However, the high price limits the use of sugammadex.\n\nThis study aims to compare the effect of half dose sugammadex and neostigmine against the moderate neuromuscular blockade of rocuronium.\n\nThe main questions it aims to answer are:\n\nDoes half dose sugammadex gives faster recovery time? Researchers will compare sugammadex to neostigmine to see if sugammadex gives faster recovery time.\n\nParticipants will:\n\nBe given sugammadex or neostigmine as a reversal drug after the operation done",[78,79,80],"Neuromuscular Blocking Agents","Reversal of Neuromuscular Blockade","Recovery Time",[9,15,82],"recovery time from neuromuscular blockade","2025-01-25",{"date":85,"type":86},"2025-01-28","ACTUAL",{"date":88,"type":86},"2024-11-05",{"date":90,"type":71},"2025-02",{"name":5,"class":6},1]