[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560314":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":46,"responsibleParty":61,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":26,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Beijing Shijitan Hospital, Capital Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"remimazolam besylate group","EXPERIMENTAL","Upon ICU admission, remimazolam besylate infusion will initiated for light sedation maintenance at a dose range of 0.1 to1.0mg\u002FKg\u002Fh. The target sedation depth is defined as a RASS score of 0 to -2. The RASS score will evaluated and recorded hourly, and the infusion rate of remimazolam besylate will titrated( increased or decreased) accordingly to maintain the patient within the target sedation range. For multimodal analgesia, remifentanil will co-administered continuously at a dose of 0.1 to 0.5ug\u002FKg\u002Fmin to ensure a CPOT score of 2 or less.",[13],"Drug: Remimazolam Besylate",{"label":15,"type":16,"description":17,"interventionNames":18},"Dexmedetomidine hydrochloride group","ACTIVE_COMPARATOR","Upon ICU admission, dexmedetomidine infusion will initiated for light sedation maintenance at a dose range of 0.2 to0.7ug\u002FKg\u002Fh. The target sedation depth is defined as a RASS score of 0 to -2. The RASS score will evaluated and recorded hourly, and the infusion rate of dexmedetomidine will titrated( increased or decreased) accordingly to maintain the patient within the target sedation range. For multimodal analgesia, remifentanil will co-administered continuously at a dose of 0.1 to 0.5ug\u002FKg\u002Fmin to ensure a CPOT score of 2 or less.",[19],"Drug: Dexmedetomidine Hydrochloride",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Remimazolam Besylate","patients will be sedated with remimazolam via intravenous pump on the day of ICU admission, the dosage will titrate with the depth of sedation evaluated with RASS. If the target sedation depth could not to achieved within the prespecified maximum dose range of remimazolam, a standardized rescue sedation protocol will intiated as follows: an intravenous bolus of propofol at 0.2mg\u002Fkg will administered. Sedation depth will evaluated 5 minutes post-injection. The identical dose of propofol bolus will repeated until the desired sedation depth is reached. Continuous propofol infusion will initiated after three consecutive bolus injections of propofol. The continuous propofol infusion rate will titrated within the range of 0.2 to 1.0 mg\u002Fkg\u002Fh until the satisfactory target sedation depth is established. At the subsequent hourly sedation assessment, continuous propofol infusion will discontinued once the patient successfully maintained a stable RASS score within the 0 to -2 range.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Dexmedetomidine Hydrochloride","patients will be sedated with dexmedetomidine hydrochloride via intravenous pump on the day of ICU admission, the dosage will titrate with the depth of sedation evaluated with RASS. If the target sedation depth could not to achieved within the prespecified maximum dose range of remimazolam, a standardized rescue sedation protocol will intiated as follows: an intravenous bolus of propofol at 0.2mg\u002Fkg will administered. Sedation depth will evaluated 5 minutes post-injection. The identical dose of propofol bolus will repeated until the desired sedation depth is reached. Continuous propofol infusion will initiated after three consecutive bolus injections. The continuous propofol infusion rate will titrated within the range of 0.2 to 1.0 mg\u002Fkg\u002Fh until the satisfactory target sedation depth is established. At the subsequent hourly sedation assessment, continuous propofol infusion will discontinued once the patient successfully maintained a stable RASS score within the 0 to -2 range.",[15],[32],{"name":33,"affiliation":5,"role":34},"Jianxin Zhou, doctor","STUDY_CHAIR",[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Yuefu Wang, doctor","CONTACT","+86","15301306289","wangyuefu3806@bjsjth.cn",{"name":43,"role":38,"phone":39,"phoneExt":44,"email":45},"Dandan Liu, doctor","13810589291","ldd3967@163.com",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":26},"Beijing Shijitan Hospital.CMU","RECRUITING","Beijing","Beijing Municipality","100038","China","CN",{"type":56,"coordinates":57},"Point",[58,59],116.39723,39.9075,{"lat":59,"lon":58},{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100560314","phase-4-efficacy-and-safety-of-remimazolam-besylate-for-sedation-in-post-non-cardiac-surgery-patients-requiring-mechanical-ventilation-100560314",false,"NCT06575530","Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation","Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged between 18 and 64 years\n* Scheduled to undergo elective non-cardiac surgery\n* Planned for general anesthesia\n* With or without combined regional nerve blockade\n* Admitted to the ICU with endotracheal intubation post-surgery\n* With an anticipated duration of postoperative mechanical ventilation greater than 24 hours\n* Clinically requiring light sedation( target RASS score 0 to -2)\n\nExclusion Criteria:\n\n* Undergoing intracranial surgery, or having a history of severe neurological or spinal cord diseases\n* Pre-existing history of schizophrenia, epilepsy, or Parkinson's disease\n* Inability to communicate preoperatively due to coma, severe dementia, or language barriers\n* Preoperative .cardiac insufficiency or severe cardiac arrhythmias\n* Severe hepatic impariment( Child-Pugh class C)\n* Severe renal impariment\n* Preoperative( within 24 hours prior to surgery) or intraoperative administration of dexmedetomidine or remimazolam\n* Pregnancy or lactation\n* Participation in any clinical trial involving investigational drugs within 30 days prior to enrollment\n* Any other conditions deemed by the investigators to render the patient unsuitable for study participation\n* Refusal to provide written informed consent","ALL","18 Years","64 Years",{"count":74,"type":75},306,"ESTIMATED","INTERVENTIONAL",[78],"PHASE4","A multi-center, prospective, randomized, double-blind, active-controlled, no-inferiority clinical trial conducted across 5 tertiary medical centers in China. The objective of this RCT is to evaluate the sedative efficacy and safety profile of remimazolam besylate compared with dexmedetomidine in patients requiring mechanical ventilation following non-cardiac surgery. The study hypothesized that remimazolam besylate is non-inferior to dexmedetomidine regarding the primary efficacy outcome.",[81,82,83,84,85,86],"Effect of Drug","Adverse Drug Event","Mechanical Ventilation Complication","Critical Illness","Surgery","Sedation","2026-06-13",{"date":89,"type":90},"2026-06-16","ACTUAL",{"date":92,"type":90},"2025-01-20",{"date":94,"type":75},"2026-06-30",{"name":5,"class":6},1]