[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"monitoring-intraoperative\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:monitoring-intraoperative":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"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":21,"type":22},240,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31,32,33],"Neuromuscular Blockade Reversal Agent","Perioperative Complications","Anesthesia, General","Sugammadex","Monitoring, Intraoperative","Masseter Muscle Spasm",[35,36,37],"sugammadex","mouth clenching","neuromuscular blockade reversal","RECRUITING","2026-07-02",{"date":41,"type":42},"2026-07-07","ACTUAL",{"date":44,"type":42},"2025-07-01",{"date":46,"type":22},"2026-10-14",{"name":48,"class":49},"Wonkwang University Hospital","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100534546","artificial-intelligence---to-predict-and-prevent-hypotension-during-surgery-100534546","NCT06240234","Artificial Intelligence - to Predict and Prevent Hypotension During Surgery","Inclusion Criteria:\n\npatients scheduled for elective major abdominal surgery at Karolinska University Hospital.\n\nExclusion Criteria:\n\nCardiac arrytmias, such as atrial fibrillation Severe pulmonary diseases, including severe chronic obstructive pulmonary disease Patient unable to understand or speak swedish and thereby dificulties to give informed concent.","18 Years",{"count":59,"type":22},300,[25],"The goal of this medtech clinical trial is to develop and evaluate a machine learning algoritm to predict low blood pressure episodes during major surgery. The main questions it aims to answer are:\n\n* Could a novel method for cardiac output estimation through alterations in carbon dioxide improve the performance of a blood pressure based algoritm in order to predict low blood pressure episodes during major abdominal surgery?\n* Will the predictive performance of the algoritm improve with the addition of other patient specific data?\n* Do the estimated cardiac output and central venous saturation by the novel method agree with our invasive arterial pressure method for cardiac output, and samples via a central venous line, respectively? 300 participants will be anesthetized with total intravenous anesthesia and ventilated with the novel carbon dioxide based method, and arterial and central venous blood gases will be taken regularly throughout the operation. All physiological data will be stored for later analyses and development of the algoritm by machine learning methods. No other invasive interventions will be performed outside our standard clinical peroperative protocol.",[32],[64,65,66],"Hypotension","Artificial intelligence","Capnodynamics","NOT_YET_RECRUITING","2024-01-26",{"date":70,"type":42},"2024-02-02",{"date":72,"type":22},"2024-02",{"date":74,"type":22},"2026-12",{"name":76,"class":77},"Region Stockholm","OTHER_GOV"]