[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100451629":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":44,"responsibleParty":63,"collaborators":66,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":26,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":26,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Zhujiang Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Remimazolam Group","EXPERIMENTAL","The patients are administered with sedation of remimazolam and analgesia of remifentanil on the basis of routine treatment. If the patient does not receive sedative drug before enrollment, patient would be administered with a bolus of remimazolam with 0.1-0.3mg\u002Fkg intravenously in 1 minute for the first time. And maintenance dose is 0.25-0.1mg\u002Fkg\u002Fh, meanwhile the dose of remimazolam should be titrated according to RASS scores. Nonbenzodiazepines could be administrated to the patients if sedation targets were not achieved, and the medication and dosage is recorded.",[13],"Drug: Remimazolam",{"label":15,"type":16,"description":17,"interventionNames":18},"Midazolam Group","PLACEBO_COMPARATOR","The patients are administered with sedation of midazolam analgesia of remifentanil on the basis of routine treatment. If the patient does not receive sedative drugs before enrollment, patients would be administered with a bolus of midazolam with 0.01-0.05mg\u002Fkg intravenously in 1 minute for the first time. And the maintenance dose is 0.02-0.1mg\u002Fkg\u002Fh, meanwhile the dose of midazolam should be titrated according to RASS scores. Nonbenzodiazepines could be administrated to the patients if sedation targets were not achieved, and the medication and dosage is recorded.",[19],"Drug: Midazolam",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Remimazolam","Remimazolam will be diluted with 0.9% saline to ensure that the therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Midazolam","Midazolam will be diluted with 0.9% saline to ensure that the therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.",[15],[32],{"name":33,"affiliation":34,"role":35},"Zhanguo Liu, M.D.PhD","Department of Critical Care Medicine of Zhujiang Hospital","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Jing Cai","CONTACT","+86-2062782927","caijing78@hotmail.com",{"name":33,"role":39,"phone":40,"phoneExt":26,"email":43},"zhanguoliu@163.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University","RECRUITING","Guangzhou","Guangdong","510282","China","CN",{"type":54,"coordinates":55},"Point",[56,57],113.25,23.11667,{"lat":57,"lon":56},[60],{"name":61,"role":39,"phone":40,"phoneExt":26,"email":62},"Ping Chang, M.D.PhD","changp963@163.com",{"type":35,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Liu Zhanguo","Deputy chief physician of critical medicine department",[67,70,72,74,76,78,80],{"name":68,"class":69},"Integrated traditional Chinese and Western Medicine Hospital of Southern Medical University","UNKNOWN",{"name":71,"class":6},"First Affiliated Hospital of Shantou University Medical College",{"name":73,"class":6},"Affiliated Hospital of Guangdong Medical University",{"name":75,"class":69},"Yunfu People's Hospital",{"name":77,"class":6},"Zhongshan Hospital Of Traditional Chinese Medicine",{"name":79,"class":69},"Guangdong Province Traditional Medical hospital",{"name":81,"class":6},"The Third Affiliated Hospital of Guangzhou Medical University","100451629","effect-of-remimazolam-with-protocolized-sedation-on-critical-ill-mechanical-ventilated-patients-compared-with-midazolam-100451629",false,"NCT05160987","Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With Midazolam","Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With Midazolam - A Parallel, Multicenter, Single-blind Randomized Controlled Trial","Inclusion Criteria:\n\n1. Critical ill patients that are mechanically ventilated within the first 48h of admission to the ICU and who would remain in the ICU for over 72h were enrolled in this study.\n2. Age 18-80 years.\n3. Voluntary informed consent.\n\nExclusion Criteria:\n\n1. Surgical treatment is performed within 24 hours.\n2. Craniocerebral injury, post neurosurgery, non drug coma, mental illness or peripheral neuropathy.\n3. Heart rates are less than 50 beats \u002F min or severe atrioventricular block without pacemaker support.\n4. The mean arterial pressure is less than 55 mmHg even though fluids and vasoactive drugs are administrated.\n5. Patients who are known or suspected allergy to benzodiazepines, propofol, dexmedetomidine or opioids.\n6. History of alcohol and drug abuse.\n7. End stages of lung diseases, such as pulmonary fibrosis, lung damage, etc.\n8. Pregnancy.","ALL","18 Years","80 Years",{"count":93,"type":94},440,"ESTIMATED","INTERVENTIONAL",[97],"NA","In this parallel, multicenter, single-blind randomized controlled trial, mechanical ventilated patients will be randomly assigned to two groups. One receives remimazolam to achieve sedation goals, while the other receives Midazolam. The primary outcome is the effect of remimazolam on duration of mechanical ventilated of critical patients compared to midazolam.",[100],"Sedation and Analgesia",[23,28,102,103],"duration of mechanical ventilation","Sedation","2026-04-15",{"date":106,"type":107},"2026-04-17","ACTUAL",{"date":109,"type":107},"2022-03-29",{"date":111,"type":94},"2027-12-31",{"name":5,"class":6},1]