[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571510":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":45,"collaborators":10,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":63,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":10,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Remimazolam Sedation Group",null,"his cohort includes patients undergoing painless gastrointestinal endoscopy (gastroscopy, colonoscopy, or both) who receive sedation with remimazolam. The study aims to evaluate the incidence of euphoria induced by remimazolam and explore related factors. All patients receive sedation according to standard clinical guidelines, including pre-procedural sufentanil and lidocaine gel for oral preparation, followed by remimazolam for induction and maintenance.\n\nData collected include demographic characteristics, pre- and post-procedure euphoria scores assessed using the ARCI-MBG scale, perioperative safety indicators, and patient satisfaction.",[13],"Drug: Remimazolam for Gastrointestinal Endoscopy Sedation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","Remimazolam for Gastrointestinal Endoscopy Sedation","This intervention involves the use of remimazolam, a short-acting benzodiazepine, for sedation during gastrointestinal endoscopy procedures (gastroscopy, colonoscopy, or both). Remimazolam is administered intravenously at an initial dose of 0.2-0.3 mg\u002Fkg, followed by additional doses of 2.5 mg as needed to maintain adequate sedation (MOAA\u002FS score ≤ 2).\n\nUnlike other benzodiazepines, remimazolam is rapidly metabolized by plasma esterases, resulting in a quick onset and recovery with minimal respiratory and cardiovascular depression. The study specifically evaluates the euphoria-inducing potential of remimazolam, using the ARCI-MBG scale pre- and post-procedure to assess its effect on patient comfort and satisfaction.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Zhangjie Yu, M.Sc.","CONTACT","0086-13761067441","novo8yu@gmail.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Renji Hospital, Shanghai Jiao Tong University School of Medicine","RECRUITING","Shanghai","Shanghai Municipality","200127","China","CN",{"type":36,"coordinates":37},"Point",[38,39],121.45806,31.22222,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":44,"phoneExt":10,"email":25},"brick yu","02168383702",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Zhangjie Yu","Attending Physician","100571510","study-on-the-feelings-of-euphoria-caused-by-remimazolam-during-gastroscopy-and-colonoscopy-and-their-related-factors-100571510",false,"NCT06721195","Study on the Feelings of Euphoria Caused by Remimazolam During Gastroscopy and Colonoscopy and Their Related Factors","A Cross-Sectional Study on Euphoria Induced by Remimazolam During Gastrointestinal Endoscopy and Its Related Factors","ERGE","Inclusion Criteria:\n\n* Adults aged 18 to 65 years, regardless of gender.\n* Patients scheduled for routine painless gastrointestinal endoscopy, including gastroscopy, colonoscopy, or both.\n* ASA physical status classification: I or II.\n* BMI between 18 kg\u002Fm² and 28 kg\u002Fm².\n* Anticipated procedural duration of no more than 30 minutes.\n* Patients who have provided written informed consent after understanding the study purpose, procedures, and potential risks.\n\nExclusion Criteria:\n\n* History of psychiatric disorders such as schizophrenia, bipolar disorder, or personality disorders, or a history of alcohol, stimulant, or other substance abuse.\n* Known allergies or intolerance to any medication used in the study, including remimazolam, sufentanil, or benzodiazepines.\n* Patients requiring complex endoscopic procedures (e.g., ERCP, endoscopic submucosal dissection, endoscopic mucosal resection, or peroral endoscopic myotomy).\n* History of severe hepatic or renal disease.\n* Pregnant or lactating women.\n* Participation in another clinical study within the past three months.\n* Any condition or factor that, in the investigator's judgment, makes the patient unsuitable for participation in the study.","ALL","18 Years","65 Years",{"count":61,"type":62},305,"ESTIMATED","1 Day","OBSERVATIONAL","This study aims to investigate the incidence of euphoria induced by remimazolam during gastrointestinal endoscopy and explore its related factors. Gastrointestinal endoscopy, a minimally invasive procedure, often causes discomfort and anxiety for patients. Remimazolam, a short-acting benzodiazepine, is increasingly used for sedation during these procedures due to its rapid onset, short metabolism, and controlled cardiorespiratory effects. This cross-sectional study will evaluate the effect of remimazolam on patient comfort, cooperation, and satisfaction during endoscopy, aiming to optimize sedation protocols and improve clinical outcomes.",[67,68,69],"Euphoria","Remimazolam Besylate","Gastrointestinal Endoscopy","2024-12-03",{"date":72,"type":73},"2024-12-06","ACTUAL",{"date":75,"type":73},"2024-08-01",{"date":77,"type":62},"2024-12-31",{"name":47,"class":6},1]