[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566306":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":41,"collaborators":26,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":26,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":26,"enrollmentInfo":52,"targetDuration":26,"studyType":55,"phases":56,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":66,"whyStopped":26,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":26},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"intravenous aceteminophen group","EXPERIMENTAL","50 ml contains 500 mg of acetaminophen will be administered for the first dose when the surgical suture begin at the end of surgery and thereafter repeated every 6 hours for the following 7 doses using automatic intravenous pump (4g acetaminophen diluted with 0.9% saline to 400 ml), and every bolus of 50 ml will be finished within 10 minutes.",[13],"Drug: Acetaminophen",{"label":15,"type":16,"description":17,"interventionNames":18},"saline placebo group","PLACEBO_COMPARATOR","50 ml 0.9% saline will be administered for the first dose placebo when the surgical suture begin at the end of surgery and thereafter repeated every 6 hours for the following 7 doses using automatic intravenous pump (400ml 0.9% saline without acetaminophen), and every bolus of 50 ml will be finished within 10 minutes.",[19],"Drug: Saline",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Acetaminophen","Acetaminophen, which has similarly effects with NSAIDs in terms of inhibition of cyclooxygenase COX1, COX2 and COX3, is widely used as adjuvant for perioperative multimodal analgesia.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Saline","Saline, a kind of crystalloid widely used in clinical treatment.",[15],[32],{"name":33,"affiliation":34,"role":35},"LIQUN YANG, MD","Anesthesiology, Renji Hospital, Shanghai Jiao Tong University, School of Medicine Shanghai, China","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","15921969001","lqyang72721@126.com",{"type":42,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100566306","phase-2-intravenous-acetaminophen-for-postoperative-delirium-in-older-patients-recovering-from-major-noncardiac-surgery-100566306",false,"NCT06653465","Intravenous Acetaminophen for Postoperative Delirium in Older Patients Recovering From Major Noncardiac Surgery","Intravenous Acetaminophen for Postoperative Delirium in Older Patients Recovering From Major Noncardiac Surgery: a Randomised Controlled Study","Inclusion Criteria:\n\n1. Age ≥ 65 years.\n2. Scheduled for non-cardiac major surgery with general anesthesia that is expected to last more than 2h.\n3. ASA Physical Status I-III.\n4. Weight \\>50 kg.\n5. Written informed consent.\n\nExclusion Criteria:\n\n1. Pre-existing neuropsychiatric diseases (Alzheimer's disease, Schizophrenia, Parkinson's Disease, Seizures, etc.).\n2. Pre-existing cognitive impairment (MMSE\\\u003C18).\n3. Preoperative delirium.\n4. Severe circulatory instability (preoperative left ventricular ejection fraction less than 30%, unstable angina, severe coronary artery disease, sick sinus syndrome, etc.).\n5. Contraindication to the acetaminophen use, including serum creatinine \\> 177µmol\u002FL or aminotransferses \\> 3 times the upper limit of normal.\n6. Alcohol or drug abuse within a year before surgery.\n7. Inability to communicate because of severe visual\u002Fauditory dysfunction or language barrier.","ALL","65 Years",{"count":53,"type":54},1930,"ESTIMATED","INTERVENTIONAL",[57,58],"PHASE2","PHASE3","Investigators propose this multi-center randomised controlled study to test the preventive effect of intravenouse acetaminophen in delirium over 5 postoperative days among older patients recovering from major non-cardiac surgery.",[61],"Delirium in Old Age",[63,64,65],"postoperative delirium","acetaminophen","elderly patient","NOT_YET_RECRUITING","2025-04-01",{"date":69,"type":70},"2025-04-04","ACTUAL",{"date":72,"type":54},"2025-06",{"date":74,"type":54},"2027-07",{"name":5,"class":6}]