[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605344":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":57,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":25,"eligibilityCriteria":64,"healthyVolunteers":61,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":81,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Humanitas Clinical and Research Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 2 (Remimazolam + Fentanyl)","ACTIVE_COMPARATOR","ARM 2: Participants receive intravenous remimazolam plus fentanyl for procedural sedation during colonoscopy",[13],"Drug: Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation.",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 1 (Midazolam + Fentanyl)","Arm Description: ARM 1: Participants receive intravenous midazolam plus fentanyl for procedural sedation during colonoscopy.",[18],"Drug: Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation.",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation.","\\- Remimazolam + Fentanyl IV fentanyl 100 mcg is given first, followed after 1 minute by IV remimazolam 5 mg over 1 minute. Additional 2.5 mg boluses may be given every 2 minutes as needed. Colonoscopy starts 1 minute after sedation. Vital signs are monitored throughout.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation.","\\- Midazolam + Fentanyl (≤1000 caratteri) IV fentanyl 100 mcg is given first, followed after 1 minute by IV midazolam 3 mg over 1 minute. Additional midazolam may be administered based on clinical judgment. Colonoscopy starts 1 minute after sedation. Vital signs are monitored throughout.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Cristina Alessandro Armuzzi, MD PhD","CONTACT","+393392529254","alessandro.armuzzi@hunimed.eu",{"name":37,"role":33,"phone":34,"phoneExt":25,"email":38},"Cristina Bezzio","bezzioc@gmail.com",[40],{"facility":41,"status":25,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Humanitas Research Hospital","Rozzano","Milano","20089","Italy","IT",{"type":48,"coordinates":49},"Point",[50,51],9.1559,45.38193,{"lat":51,"lon":50},[54,56],{"name":55,"role":33,"phone":34,"phoneExt":25,"email":35},"Alessandro Armuzzi, MD PhD",{"name":37,"role":33,"phone":25,"phoneExt":25,"email":38},{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100605344","phase-4-remimazolam-for-colonoscopy-in-ibd-patients-100605344",false,"NCT07161297","Remimazolam for Colonoscopy in IBD Patients","* Inclusion Criteria\n\n  * Age ≥18 years\n  * Diagnosis of IBD (CD or UC) for ≥6 months\n  * Scheduled colonoscopy for clinical or surveillance purposes\n  * Ability to provide informed consent\n* Exclusion Criteria\n\n  * ASA class IV\n  * Allergy to benzodiazepines, opioids, flumazenil, or naloxone\n  * Severe COPD\n  * Obstructive sleep apnea\n  * BMI \\>35\n  * Pregnancy or lactation\n  * Prior multiple ileocolonic resections or subtotal colectomy\n  * Inability to complete questionnaires","ALL","18 Years","90 Years",{"count":69,"type":70},200,"ESTIMATED","INTERVENTIONAL",[73],"PHASE4","The goal of this clinical trial is to compare two sedation regimens-remimazolam and midazolam-for colonoscopy in adult patients with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis.\n\nThe main questions it aims to answer are:\n\n* Does remimazolam provide patient satisfaction that is non-inferior to midazolam during colonoscopy?\n* Does remimazolam allow faster recovery and discharge readiness compared to midazolam?\n\nResearchers will compare sedation with remimazolam plus fentanyl to sedation with midazolam plus fentanyl to see if remimazolam improves patient experience and procedural efficiency.\n\nParticipants will:\n\n* Receive either remimazolam or midazolam, each combined with fentanyl, during their scheduled colonoscopy\n* Complete a short questionnaire to rate their satisfaction after the procedure\n* Be assessed for recovery using a standardized discharge score at 10 and 20 minutes after the procedure",[76],"IBD (Inflammatory Bowel Disease)",[78,79,80],"Inflammatory bowel disease (IBD)","Remimazolam","Midazolam","NOT_YET_RECRUITING","2025-09-01",{"date":84,"type":85},"2025-09-08","ACTUAL",{"date":82,"type":70},{"date":88,"type":70},"2025-09-30",{"name":5,"class":6},1]