[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651262":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":10,"responsibleParty":21,"collaborators":10,"id":25,"slug":26,"hasResults":27,"nctId":28,"briefTitle":29,"officialTitle":30,"acronym":10,"eligibilityCriteria":31,"healthyVolunteers":27,"sex":32,"minAge":33,"maxAge":10,"enrollmentInfo":34,"targetDuration":10,"studyType":37,"phases":10,"briefSummary":38,"conditions":39,"keywords":45,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":10},{"fullName":5,"class":6},"Mersin University","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Unsedated PEG",null,"Elderly ASA IV patients undergoing percutaneous endoscopic gastrostomy with topical pharyngeal anesthesia and local anesthesia, without systemic sedative medication.",{"label":13,"type":10,"description":14,"interventionNames":10},"Sedated PEG","Elderly ASA IV patients undergoing percutaneous endoscopic gastrostomy under sedation as part of routine clinical practice. Sedative agents may include propofol, midazolam, and\u002For opioid agents according to clinical and anesthesiology evaluation.",[16],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Mahsum Barçın, MD","CONTACT","+9005448895064","dr.mahsumbarcin@gmail.com",{"type":22,"investigatorFullName":23,"investigatorTitle":24,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Hilmi Bozkurt","Associate Professor of General Surgery","100651262","comparison-of-sedated-and-unsedated-peg-in-elderly-asa-iv-patients-100651262",false,"NCT07758153","Comparison of Sedated and Unsedated PEG in Elderly ASA IV Patients","Comparison Of Safety And Clinical Outcomes Of Sedated And Unsedated Percutaneous Endoscopic Gastrostomy Procedures İn ASA IV Elderly Patients: A Prospective Observational Cohort Study.","Inclusion Criteria:\n\n* Patients aged 65 years and older Patients classified as ASA physical status IV Patients with an indication for percutaneous endoscopic gastrostomy for long-term enteral nutrition Patients scheduled to undergo PEG placement in routine clinical practice Written informed consent obtained from the patient or legally authorized representative Availability of clinical, laboratory, procedural, and follow-up data\n\nExclusion Criteria:\n\n* Requirement for emergency PEG placement International normalized ratio greater than 1.5 Platelet count less than 50,000\u002Fmm³ Massive ascites Active peritonitis Previous total gastrectomy Pregnancy Refusal to participate in the study","ALL","65 Years",{"count":35,"type":36},70,"ESTIMATED","OBSERVATIONAL","This prospective observational cohort study aims to compare the safety and clinical outcomes of sedated and unsedated percutaneous endoscopic gastrostomy procedures in elderly patients classified as ASA IV. The primary outcome is the development of cardiopulmonary complications within the first 24 hours after the procedure. Secondary outcomes include technical success, procedure duration, early procedure-related complications, length of hospital stay, intensive care requirement, 30-day mortality, and 30-day readmission.",[40,41,42,43,44],"Percutaneous Endoscopic Gastrostomy","Enteral Nutrition Feeding","Dysphagia","Elderly Patients (>65 Years)","ASA Physical Status IV",[46,47,9,48,49],"Percutaneous endoscopic gastrostomy","Sedation","ASA IV","Cardiopulmonary complications","NOT_YET_RECRUITING","2026-08-06",{"date":53,"type":54},"2026-08-11","ACTUAL",{"date":56,"type":36},"2026-07-15",{"date":58,"type":36},"2027-07",{"name":5,"class":6}]