[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623358":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":72,"collaborators":75,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":26,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":26,"enrollmentInfo":91,"targetDuration":26,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":104,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"First Affiliated Hospital of Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"The propofol - alfentanil group（The control group）","ACTIVE_COMPARATOR","In this group, general anesthesia was administered using the classic propofol and alfentanil. The patients underwent fiberoptic bronchoscopy while maintaining spontaneous breathing and with a MOAA\u002FS score of ≤2.",[13],"Drug: propofol and alfentanil",{"label":15,"type":16,"description":17,"interventionNames":18},"The remimazolam and propofol - alfentanil group (The experimental group)","EXPERIMENTAL","This group received general anesthesia with remimazolam combined with propofol for sedation and alfentanil. Fiberoptic bronchoscopy was done while patients maintained spontaneous breathing and had a MOAA\u002FS score of ≤2.",[19],"Drug: remimazolam combined with propofol and alfentanil",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","propofol and alfentanil","General anesthesia with spontaneous breathing maintained is administered using propofol and alfentanil.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"remimazolam combined with propofol and alfentanil","General anesthesia with spontaneous breathing maintained is administered using remimazolam combined with propofol and alfentanil.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Yueying Zheng","CONTACT","+8613777408863","1507128@zju.edu.cn",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Yeke Zhu","+8613515815457","21618018@zju.edu.cn",[42,58],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"The First Affliated Hospital, Zhejiang University School Of Medicine","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":51,"coordinates":52},"Point",[53,54],120.16142,30.29365,{"lat":54,"lon":53},[57],{"name":26,"role":34,"phone":39,"phoneExt":26,"email":40},{"facility":59,"status":60,"city":61,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Shaoxing City First People's Hospital","NOT_YET_RECRUITING","Shaoxing",{"type":51,"coordinates":63},[64,65],120.57864,30.00237,{"lat":65,"lon":64},[68],{"name":69,"role":34,"phone":70,"phoneExt":26,"email":71},"Zhonghua Chen","+8613867502391","841135078@qq.com",{"type":73,"investigatorFullName":33,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Vice Director of the Department of Anesthesiology",[76,78,80],{"name":77,"class":6},"Shaoxing People's Hospital",{"name":79,"class":6},"Affiliated Hospital of Jiaxing University",{"name":81,"class":6},"The Second Affiliated Hospital of Jiaxing University","100623358","phase-4-remimazolam-for-bronchoscopy-in-high-risk-patients-100623358",false,"NCT07395596","Remimazolam for Bronchoscopy in High-Risk Patients","A Prospective, Randomized Controlled Clinical Study of the Effect of Remimazolam on the Incidence of Hypoxia in High-risk Patients Undergoing Painless Tracheoscopy","Inclusion Criteria:\n\n* ASA Class Ⅲ - Ⅳ\n* Scheduled for elective painless bronchoscopy -\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Patients who are uncooperative（e.g. due to mental illness）\n* Patients who are on chronic use of opioids, benzodiazepine - class hypnotics, or antidepressants\n* Patients with a history of allergy to the anesthetics used\n* Patients who are anticipated to have a difficult airway\n* Body mass index（BMI）\\\u003C18.5kg\u002Fm² or \\>30kg\u002Fm²\n* Preoperative oxygen saturation \\\u003C92% while breathing room air\n* Other：Patients who are deemed by the investigator to be unsuitable for participation in this trial","ALL","18 Years",{"count":92,"type":93},360,"ESTIMATED","INTERVENTIONAL",[96],"PHASE4","Bronchoscopy is currently widely used for the diagnosis and treatment of various respiratory diseases. However, the operation of bronchoscopy is irritating, causes a strong stress response, and shares the airway with the patient, making the patient highly susceptible to respiratory and cardiovascular risks. Among these risks, hypoxia is the most common adverse event.Different drug regimens can be selected for anesthesia under deep sedation. The combination of analgesic agents can help reduce coughing during bronchoscopy. Therefore, we employ a combination of sedative and analgesic drugs for painless bronchoscopy procedures. Among sedatives, propofol is the most commonly used. However, due to its disadvantages, such as respiratory and circulatory depression, we have introduced a novel approach combining remimazolam for sedation. The aim is to investigate whether this new regimen, compared to traditional propofol-based sedation, can reduce the incidence of hypoxia, minimize circulatory depression, and lead to faster postoperative awakening and recovery. Additionally, we hope to observe fewer adverse events, such as perioperative nausea and vomiting, excessive secretions, dizziness, and chills.",[99,100,101,102,103],"Pulmonary Infection","Pulmonary Nodule","Phthisis","Endotracheal Tumour","Lymphadenectasis",[105,106,107,108],"hypoxia","remimazolam","propofol","fiberoptic bronchoscopy","2026-02-21",{"date":111,"type":112},"2026-02-24","ACTUAL",{"date":114,"type":112},"2026-02-09",{"date":116,"type":93},"2026-12",{"name":5,"class":6},2]