[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640506":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":34,"responsibleParty":51,"collaborators":11,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":57,"sex":61,"minAge":62,"maxAge":11,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":37,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Southeast University, China","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"remimazolam","EXPERIMENTAL",null,[13],"Drug: Remimazolam",{"label":15,"type":16,"description":11,"interventionNames":17},"propofol","ACTIVE_COMPARATOR",[18],"Drug: propofol",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Remimazolam","In the intervention group, patients with a Richmond Agitation-Sedation Scale (RASS) score of -3 to 0 were given remimazolam besylate for injection at a loading dose of 0.08 mg\u002Fkg infused intravenously over 10 min, followed by a continuous infusion at a rate of 0.2 mg\u002Fkg\u002Fh. When dose adjustment was required, each step was 0.1-0.2 mg\u002Fkg\u002Fh, with a dose range of 0-2 mg\u002Fkg\u002Fh, until the target sedation level (RASS: -3 to 0) was achieved. If the target sedation level was not reached, an additional bolus dose of 0.08 mg\u002Fkg remimazolam besylate could be administered.",[9],{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":11},"In the control group, patients received propofol emulsion injection at a loading dose of 0.3 mg\u002Fkg\u002Fh injected over 1 min, followed by a continuous infusion at a rate of 0.3 mg\u002Fkg\u002Fh. Dose adjustments were made in increments of 0.3-0.6 mg\u002Fkg\u002Fh, within a dose range of 0.3-4 mg\u002Fkg\u002Fh, to achieve the target sedation level (RASS: -3 to 0).",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Jingyuan Xu, M.D.","CONTACT","00862583262500","xujingyuanmail@163.com",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Zhongda Hospital","RECRUITING","Nanjing","Jiangsu","210009","China","CN",{"type":44,"coordinates":45},"Point",[46,47],118.77778,32.06167,{"lat":47,"lon":46},[50],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Jingyuan,Xu","Clinical Professor","100640506","phase-3-effect-of-remimazolam-sedation-on-outcomes-of-mechanically-ventilated-patients-in-the-icu-100640506",false,"NCT07596589","Effect of Remimazolam Sedation on Outcomes of Mechanically Ventilated Patients in the ICU","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Endotracheal intubation and mechanical ventilation for 24-96 hours before enrollment Expected need for continued invasive ventilation and sedation for at least 24 hours;\n* Target sedation depth on the Richmond Agitation-Sedation Scale (RASS) between 0 and -3;\n* Informed consent obtained from the patient's family\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\> 30 kg\u002Fm²\n* Severe central nervous system disease (e.g., acute stroke, uncontrolled seizures, or severe dementia) or any other condition that precludes RASS assessment\n* Mean arterial pressure (MAP) \\\u003C 55 mmHg despite intravenous fluid resuscitation and vasopressors\n* Heart rate \\\u003C 50 beats per minute, or second-degree or third-degree atrioventricular block in the absence of a pacemaker\n* Acute myocardial infarction or severe heart failure (New York Heart Association \\[NYHA\\] class IV)\n* Left ventricular ejection fraction \\\u003C 30%\n* Any contraindication or allergy to benzodiazepines\n* Substance dependence, alcohol abuse, or psychiatric\u002Fpsychological disorders. Alcohol abuse was defined as regular consumption of \\> 14 drinks per week (1 drink = 150 mL wine, 360 mL beer, or 45 mL liquor)\n* Acute hepatitis or severe hepatic dysfunction (Child-Pugh class C)\n* Chronic kidney disease with a glomerular filtration rate (GFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m²\n* Neuromuscular disease\n* Patients on extracorporeal membrane oxygenation (ECMO)\n* Pregnancy or breastfeeding","ALL","18 Years",{"count":64,"type":65},80,"ESTIMATED","INTERVENTIONAL",[68],"PHASE3","The goal of this clinical trial is to evaluate the effect of remimazolam sedation on outcomes of mechanically ventilated ICU patients through a single-center, prospective, randomized controlled, pilot study.",[71,72,73],"Remimazolam Besylate","Mechanically Ventilated ICU Patients","Sedation",[9,75,76],"sedation","ICU","2026-05-18",{"date":79,"type":80},"2026-05-19","ACTUAL",{"date":82,"type":80},"2025-04-01",{"date":84,"type":65},"2027-01-31",{"name":5,"class":6},1]