[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550828":3},{"organization":4,"outcomesModule":7,"designInfo":74,"detailedDescription":26,"studyPopulation":26,"armGroups":80,"interventions":98,"overallOfficials":26,"centralContacts":26,"locations":116,"responsibleParty":142,"collaborators":144,"id":170,"slug":26,"hasResults":171,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":177,"sex":178,"minAge":179,"maxAge":26,"enrollmentInfo":180,"targetDuration":26,"studyType":183,"phases":184,"briefSummary":186,"conditions":187,"keywords":26,"overallStatus":119,"whyStopped":26,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},{"fullName":5,"class":6},"Second Affiliated Hospital of Wenzhou Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":69},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Neurocognitive Disorders (NCD) events rate during the first 7 postoperative days","Neurocognitive Disorders includes:\n\n1. Postoperative delirium (POD) was mesaured by 3D-CAM;\n2. Neurocognitive decline was mesaured within 7 postoperative days by: Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA), and neuropsychological tests containing 5 cognitive latitudes (1. digit span test (DST); 2. trail making test (TMT); 3. Boston naming test (BNT); 4. auditory verbal learning test-Huashan version (AVLT-H)；5. clock drawing test (CDT).）, and active report of patients or family members).","during the first 7 postoperative days",[14,17,20,24,28,32,35,39,42,45,49,53,56,59,62,65],{"measure":15,"description":16,"timeFrame":12},"Subtypes, severity, and duration of delirium","Using CAM-S, and in units of days from the onset of delirium symptoms to the disappearance of symptoms or when the patient is discharged.",{"measure":18,"description":19,"timeFrame":12},"Neurocognitive decline in postoperative 7 days","Neurocognitive decline was mesaured by: Mini-Mental State Examination (MMSE) or Montreal Cognitive Assessment (MoCA), or neuropsychological tests containing 5 cognitive latitudes (1. digit span test (DST); 2. trail making test (TMT); 3. Boston naming test (BNT); 4. auditory verbal learning test-Huashan version (AVLT-H)；5. clock drawing test (CDT).）, or active report of patients or family members.",{"measure":21,"description":22,"timeFrame":23},"Delayed neurocognitive recovery during 30 postoperative days","This was mesaured by: Mini-Mental State Examination (MMSE) or Montreal Cognitive Assessment (MoCA), or neuropsychological tests containing 5 cognitive latitudes (1. digit span test (DST); 2. trail making test (TMT); 3. Boston naming test (BNT); 4. auditory verbal learning test-Huashan version (AVLT-H)；5. clock drawing test (CDT).）, or active report of patients or family members.","during 30 postoperative days",{"measure":25,"description":26,"timeFrame":27},"Hospital Anxiety and Depression Scale (HADs)",null,"during postoperative one year",{"measure":29,"description":30,"timeFrame":31},"Acute pain before surgery","Using Visual Analogue Scale (VAS)","1, 2, 3 days after surgery",{"measure":33,"description":26,"timeFrame":34},"Length of hospitalization","days from admission to discharge, an average of 7 days",{"measure":36,"description":37,"timeFrame":38},"Complications (except cognitive impairment)","including pulmonary infection, myocardial infarction, renal failure, gastrointestinal obstruction, etc.","during postoperation 30 days",{"measure":40,"description":26,"timeFrame":41},"Mortality","30 days",{"measure":43,"description":26,"timeFrame":44},"Days at home up to 30 days after surgery (DAH30)","up to 30 days after surgery",{"measure":46,"description":47,"timeFrame":48},"Score of EuroQol Five Dimensions Questionnaire (EQ-5D)","using EQ-5D to measure quality of life","1 week before fracture (review); 1 month; 6 months; and 12 months after surgery.",{"measure":50,"description":51,"timeFrame":52},"Incidence of postoperative Neurocognitive Disorders (NCD)","This was mesaured within 7 postoperative days by: Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA), and neuropsychological tests containing 5 cognitive latitudes (1. digit span test (DST); 2. trail making test (TMT); 3. Boston naming test (BNT); 4. auditory verbal learning test-Huashan version (AVLT-H)；5. clock drawing test (CDT).), and active report of patients or family members).","within 1 year after surgery (long-term)",{"measure":54,"description":55,"timeFrame":52},"Severity of postoperative Neurocognitive Disorders (NCD)","Includes major and mild postoperative NCD",{"measure":57,"description":58,"timeFrame":52},"Type of postoperative Neurocognitive Disorders (NCD)","Using Hachinski Ischemic Scale (HIS) combined with clinical symptoms and auxiliary examination to mesaure the type of postoperative NCD. HIS ≥7 was considered as vascular cognitive impairment.",{"measure":60,"description":61,"timeFrame":52},"Instrumental Daily Living Ability Scale (IADL)","IADL ≤6 is normal",{"measure":63,"description":26,"timeFrame":64},"1-year all-cause mortality","1-year after surgery",{"measure":66,"description":67,"timeFrame":68},"Economic indicators","* Hospitalization fees;\n* Preoperative fees;\n* Anesthesia fees;\n* Surgery fees;\n* Post-operative fees;\n* Post-discharge medical expenses.","during the entire trial, an average of 1 year.",[70],{"measure":71,"description":72,"timeFrame":73},"Incidence of adverse events","We will collect the following known potential risks of general and local anesthesia from the start of the intervention to the subject's discharge and assess the overall incidence:\n\n1. cardiopulmonary resuscitation;\n2. Malignant hyperthermia or anaphylaxis;\n3. Aspiration pneumonia ;\n4. Epidural hematoma ;\n\n6\\) Patients who did not need mechanical ventilation before surgery continued with unplanned mechanical ventilation for more than 6 hours after surgery; 7) Other adverse events during postoperative hospitalization.","during hospitalization, an average of 7 days; through entire trial, an average of 1 year.",{"allocation":75,"interventionModel":76,"interventionModelDescription":26,"primaryPurpose":77,"observationalModel":26,"timePerspective":26,"maskingInfo":78},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":79,"maskingDescription":26,"whoMasked":26},"NONE",[81,89,94],{"label":82,"type":83,"description":84,"interventionNames":85},"Nerve block + standard anesthesia protocol","EXPERIMENTAL","(described in detail in sub-trial protocol 1)",[86,87,88],"Other: Nerve block+standard anesthesia","Drug: Bupivacaine liposome","Device: Ultrasound-guided nerve block",{"label":90,"type":83,"description":91,"interventionNames":92},"Intravenous infusion of lidocaine + standard anesthesia protocol","(described in detail in sub-trial protocol 2)",[93],"Drug: Intravenous lidocaine+standard anesthesia",{"label":95,"type":96,"description":97,"interventionNames":26},"Standard anesthesia protocol","NO_INTERVENTION","(If an intervention was found to be effective in the interim analysis, the executive committee will decide whether to add it to the standard anesthesia protocol.)",[99,103,108,112],{"type":6,"name":100,"description":101,"armGroupLabels":102,"otherNames":26},"Nerve block+standard anesthesia","1. Receive nerve block as soon as possible after randomization;\n2. Ultrasound-guided nerve block is recommended, with the iliacfascia block recommended as the blocking site;\n3. It is recommended to use 1.33% bupivacaine liposome (long-acting), and the maximum dose should not exceed 133mg; or regular local anesthetic (bupivacaine or ropivacaine, etc.) with electronic analgesic pumping infusion; or multiple single injections of regular local anesthetics should be used to maintain the continuity of nerve block effect.",[82],{"type":104,"name":105,"description":106,"armGroupLabels":107,"otherNames":26},"DRUG","Intravenous lidocaine+standard anesthesia","1. Subjects randomly assigned to Lidocaine Group (Group L) will be given ECG monitoring, oxygen saturation monitoring, blood pressure monitoring and an open intravenous route on the morning of the surgery. It is recommended to start the infusion of Lidocaine as soon as possible in the ward.\n2. It is recommended to use portable electronic infusion pump for drug delivery. The loading dose is 1mg\u002Fkg, and the maintenance dose range is 1\\~2mg\u002Fkg\u002Fh. The specific dosage is determined by the anesthesiologist based on the patient's condition. The infusion ends when the patient leaves the Post-anesthesia care unit after surgery, and the infusion time and total amount should be recorded.",[90],{"type":104,"name":109,"description":110,"armGroupLabels":111,"otherNames":26},"Bupivacaine liposome","1.33% bupivacaine liposome",[82],{"type":113,"name":114,"description":114,"armGroupLabels":115,"otherNames":26},"DEVICE","Ultrasound-guided nerve block",[82],[117],{"facility":118,"status":119,"city":120,"state":121,"zip":122,"country":123,"countryCode":124,"cosmosGeoPoint":125,"geoPoint":130,"contacts":131},"The Second Affilliated Hospital and Yuying Children's Hospital of Wenzhou Medical University","RECRUITING","Wenzhou","Zhejiang","325000","China","CN",{"type":126,"coordinates":127},"Point",[128,129],120.66682,27.99942,{"lat":129,"lon":128},[132,137,139],{"name":133,"role":134,"phone":135,"phoneExt":26,"email":136},"Ting Li, PhD","CONTACT","13587876896","liting1021@aliyun.com",{"name":133,"role":138,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"name":140,"role":141,"phone":26,"phoneExt":26,"email":26},"Bingwu Huang, PhD","SUB_INVESTIGATOR",{"type":143,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[145,147,149,151,153,155,157,159,161,164,166,168],{"name":146,"class":6},"Zhejiang Provincial People's Hospital",{"name":148,"class":6},"First Affiliated Hospital of Wenzhou Medical University",{"name":150,"class":6},"Ningbo No.2 Hospital",{"name":152,"class":6},"Ningbo No.6 Hospital",{"name":154,"class":6},"Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University",{"name":156,"class":6},"Taizhou Hospital",{"name":158,"class":6},"Affiliated Wenling Hospital of Wenzhou Medical University",{"name":160,"class":6},"Lishui Country People's Hospital",{"name":162,"class":163},"The Fifth Hospital Affiliated to Wenzhou Medical University\u002F Lishui Central Hospital","UNKNOWN",{"name":165,"class":6},"Jinhua Municipal Central Hospital",{"name":167,"class":6},"Dongyang People's Hospital",{"name":169,"class":6},"People's Hospital of Quzhou","100550828",false,"NCT06452147","Anesthesia and Perioperative Neurocognitive Disorders in the Elderly Patients Undergoing Hip Fracture Surgery Platform Trial (ANDES Platform Trial)","Anesthesia and Perioperative Neurocognitive Disorders in the Elderly Patients Undergoing Hip Fracture Surgery Platform Trial (ANDES Platform Trial): A Pragmatic Multi-arm, Adaptive, Open Label, Multicenter Randomized Controlled Platform Trial to Assess the Effect of Different Enhance Anesthesia Technique in Perioperative Neurocognitive Function, as Compared to Standard Anesthesia Care in the Elderly Patients Undergoing Hip Fracture","ANDES platform","Inclusion Criteria:\n\n1. Aged 65 years and older.\n2. Patients with unilateral hip fracture (including femoral neck, femoral head, intertrochanteric and subtrochanteric fractures) are scheduled for surgical treatment.\n3. American Society of Anesthesiologists (ASA) physical status IV or below.\n4. The patients or family members provide written informed consent.\n5. Additional inclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.\n\nExclusion Criteria:\n\n1. Patients with multiple trauma or fractures (excluding trauma that the researcher judges will not affect the patient's overall recovery, such as simple spinal compression fractures, mild soft tissue contusions, fractures of hands and feet, etc.);\n2. Two or more anesthetic surgeries are required.\n3. Petients with an obvious history of head trauma (such as loss of consciousness for more than 5 minutes, post-traumatic amnesia, etc.);\n4. Patients who the researcher believes are unable to complete the assessment of primary outcome;\n5. Additional exclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.",true,"ALL","65 Years",{"count":181,"type":182},1860,"ESTIMATED","INTERVENTIONAL",[185],"NA","Anesthesia and perioperative Neurocognitive Disorders in the Elderly patients undergoing hip fracture Surgery platform trial (ANDES platform trial): A pragmatic multi-arm, adaptive, open label, multicenter randomized controlled platform trial to assess the effect of different enhance anesthesia technique in perioperative neurocognitive function, as compared to standard anesthesia care in the elderly patients undergoing hip fracture",[188,189,190,191,192],"Anesthesia","Hip Fractures","Dementia","Cognitive Impairment","Cognitive Decline","2024-11-07",{"date":195,"type":196},"2024-11-08","ACTUAL",{"date":198,"type":196},"2024-06-19",{"date":200,"type":182},"2028-07-30",{"name":5,"class":6},1]