[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639926":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":10,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":10,"id":53,"slug":10,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":10,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":79,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Bach Mai Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort Description",null,"Adult patients undergoing diagnostic esophagogastroduodenoscopy, diagnostic colonoscopy, or combined diagnostic upper and lower gastrointestinal endoscopy with propofol as the primary sedative\u002Fanesthetic agent at a tertiary referral hospital. All enrolled participants will receive standard peri-procedural monitoring and will be followed from pre-sedation assessment through discharge from the recovery area. If early post-procedure observation is prolonged because of a sedation-related cardiopulmonary event, follow-up for that participant will continue until initial stabilization and an immediate post-procedure management decision are completed.",[13,14],"Drug: Propofol","Procedure: Diagnostic gastrointestinal endoscopy",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"DRUG","Propofol","Propofol is the primary sedative\u002Fanesthetic agent used for diagnostic gastrointestinal endoscopy according to routine clinical practice. The loading dose, incremental bolus doses, maintenance infusion rate if used, total dose, weight-normalized total dose, timing of administration, and any adjunct sedative or analgesic medications will be recorded as observational exposure variables.",[9],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"PROCEDURE","Diagnostic gastrointestinal endoscopy","Diagnostic gastrointestinal endoscopy includes esophagogastroduodenoscopy, colonoscopy, or combined diagnostic upper and lower gastrointestinal endoscopy performed without therapeutic intervention.",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Thang Toan Nguyen, PhD","CONTACT","+084916874795","nguyentoanthang@hmu.edu.vn",[33],{"facility":34,"status":10,"city":35,"state":10,"zip":10,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital","Hanoi","Vietnam","VN",{"type":39,"coordinates":40},"Point",[41,42],105.84117,21.0245,{"lat":42,"lon":41},[45],{"name":46,"role":29,"phone":47,"phoneExt":10,"email":48},"Center for Anesthesia and Intensive Care, Bach Mai Hospital. Center for Anesthesia and Intensive Care, Bach Mai Hospital.","+084869587720","trungtamgaymehoisuc@bachmai.edu.vn",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Nguyen Toan Thang","Consultant Anesthesiologist","100639926",false,"NCT07613073","Predictors of Clinically Relevant Hypotension and Hypoxemia During Propofol-Based Diagnostic Gastrointestinal Endoscopy","Independent Predictors of Clinically Relevant Hypotension and Hypoxemia During During Propofol-Based Diagnostic Gastrointestinal Endoscopy: A Prospective Cohort Study","PRO-GI SAFE","Inclusion Criteria:\n\n* Age 18 years or older\n* Scheduled for diagnostic esophagogastroduodenoscopy, diagnostic colonoscopy, or combined diagnostic upper and lower gastrointestinal endoscopy\n* Planned use of propofol as the primary sedative\u002Fanesthetic agent for diagnostic gastrointestinal endoscopy\n* American Society of Anesthesiologists physical status I to III\n* Able to provide informed consent or has legally authorized representative consent according to local regulations\n\nExclusion Criteria:\n\n* Therapeutic or interventional gastrointestinal endoscopy, including ERCP, EUS-guided intervention, EMR, ESD, endoscopic hemostasis, or polypectomy\n* Planned sedation\u002Fanesthesia without propofol as the primary sedative\u002Fanesthetic agent\n* Known allergy or contraindication to propofol\n* Pregnancy or suspected pregnancy\n* Emergency condition requiring immediate advanced airway control before the procedure\n* Inability to obtain essential baseline or outcome data required for the study","ALL","18 Years",{"count":63,"type":64},1000,"ESTIMATED","OBSERVATIONAL","This prospective observational cohort study will evaluate the incidence and independent predictors of clinically relevant hypotension and hypoxemia during propofol-based diagnostic gastrointestinal endoscopy in adult patients at a tertiary referral hospital in Vietnam. Participants undergoing diagnostic upper gastrointestinal endoscopy, colonoscopy, or combined diagnostic procedures with propofol administration will be followed from pre-procedure assessment through the early recovery period. The study will assess demographic, clinical, airway, procedural, and sedation-related variables associated with clinically relevant cardiopulmonary adverse events.",[68,69],"Hypotension","Hypoxemia",[71,72,73,74,75,76,77,78],"Propofol sedation","Gastrointestinal endoscopy","Colonoscopy","Upper gastrointestinal endoscopy","Oxygen desaturation","Hemodynamic instability","Prospective cohort","Procedural sedation","NOT_YET_RECRUITING","2026-05-21",{"date":82,"type":83},"2026-05-29","ACTUAL",{"date":85,"type":64},"2026-05-15",{"date":87,"type":64},"2026-10-30",{"name":5,"class":6},1]