[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571261":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":25,"responsibleParty":29,"collaborators":25,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":37,"acronym":25,"eligibilityCriteria":38,"healthyVolunteers":35,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":25,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":25,"overallStatus":51,"whyStopped":25,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":25},{"fullName":5,"class":6},"Chinese Academy of Medical Sciences, Fuwai Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"remimazolam besylate","EXPERIMENTAL","Patients received an initial dose of remimazolam (0.3mg\u002Fkg) for induction and a continuous infusion rate of 1 mg\u002Fkg\u002Fh for anesthesia maintenance.",[13],"Drug: remimazolam besylate",{"label":15,"type":16,"description":17,"interventionNames":18},"propofol","ACTIVE_COMPARATOR","Patients received an initial dose of propofol (1.0 mg\u002Fkg) and a continuous infusion rate of 1-1.5 mg\u002Fkg\u002Fh",[19],"Drug: propofol",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Patients received an initial dose of remimazolam (0.3mg\u002Fkg) for induction and a continuous infusion rate of 1 mg\u002Fkg\u002Fh for anesthesia maintenance. Sedative was adjusted to maintain a bispectral index (BIS) at 40-60 after induction.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Patients received an initial dose of propofol (1.0 mg\u002Fkg) and a continuous infusion rate of 1-1.5 mg\u002Fkg\u002Fh. Sedative was adjusted to maintain a bispectral index (BIS) at 40-60 after induction.",[15],{"type":30,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","SHI Jia","director of department of Anesthesiology","100571261","early-phase-1-the-efficacy-and-safety-of-remimazolam-besylate-for-cardiac-anesthesia-100571261",false,"NCT06717945","The Efficacy and Safety of Remimazolam Besylate for Cardiac Anesthesia","Inclusion Criteria:\n\n1. Elective cardiac surgery via cardiopulmonary bypass;\n2. Aged 18-65 years;\n3. American Society of Anesthesiologists (ASA) grade I-III;\n4. Body mass index (BMI) 18-28 kg\u002Fm2.\n\nExclusion Criteria:\n\n1. A history of sternotomy for heart disease;\n2. Angina or arrhythmia with severe dynamics flutters pre-operation;\n3. Respiratory, hepatic or renal dysfunction (oxygenation index\\\u003C300, alanine transaminase\\> 2 upper limits of normal value, creatinine \\> 200 μmol\u002FL);\n4. Diagnosed with advanced tumors;\n5. Psychiatric or mental disorders;\n6. Myasthenia gravis or seizures;\n7. Pregnant or lactating females;\n8. A history of benzodiazepines administration within 3 months before surgery;\n9. Known allergic to benzodiazepines, opioids, propofol and flumazenil;\n10. Involved in another interventional clinical trial.","ALL","18 Years","65 Years",{"count":43,"type":44},320,"ESTIMATED","INTERVENTIONAL",[47],"EARLY_PHASE1","The evidence on the practice of remimazolam besylate during cardiac anesthesia is scarce. This study investigates the efficacy and safety of remimazolam besylate general induction and maintenance during cardiac surgery.",[50],"Anesthesia","NOT_YET_RECRUITING","2024-12-01",{"date":54,"type":55},"2024-12-05","ACTUAL",{"date":57,"type":44},"2025-01",{"date":59,"type":44},"2025-06",{"name":5,"class":6}]