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| Name | Class |
|---|---|
| Zhejiang Provincial People's Hospital | OTHER |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| Ningbo No.2 Hospital | OTHER |
| Ningbo No.6 Hospital |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerve block + standard anesthesia protocol | Experimental | (described in detail in sub-trial protocol 1) |
|
| Intravenous infusion of lidocaine + standard anesthesia protocol | Experimental | (described in detail in sub-trial protocol 2) |
|
| 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.) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerve block+standard anesthesia | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Neurocognitive Disorders (NCD) events rate during the first 7 postoperative days | Neurocognitive Disorders includes:
| during the first 7 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during the first 7 postoperative days |
| Neurocognitive decline in postoperative 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
6) 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affilliated Hospital and Yuying Children's Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325000 | China |
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| OTHER |
| Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University | OTHER |
| Taizhou Hospital | OTHER |
| Affiliated Wenling Hospital of Wenzhou Medical University | OTHER |
| Lishui Country People's Hospital | OTHER |
| The Fifth Hospital Affiliated to Wenzhou Medical University/ Lishui Central Hospital | UNKNOWN |
| Jinhua Municipal Central Hospital | OTHER |
| Dongyang People's Hospital | OTHER |
| People's Hospital of Quzhou | OTHER |
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|
| Intravenous lidocaine+standard anesthesia | Drug |
|
|
| Bupivacaine liposome | Drug | 1.33% bupivacaine liposome |
|
| Ultrasound-guided nerve block | Device | Ultrasound-guided nerve block |
|
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. |
| during the first 7 postoperative days |
| 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 |
| Hospital Anxiety and Depression Scale (HADs) | during postoperative one year |
| Acute pain before surgery | Using Visual Analogue Scale (VAS) | 1, 2, 3 days after surgery |
| Length of hospitalization | days from admission to discharge, an average of 7 days |
| Complications (except cognitive impairment) | including pulmonary infection, myocardial infarction, renal failure, gastrointestinal obstruction, etc. | during postoperation 30 days |
| Mortality | 30 days |
| Days at home up to 30 days after surgery (DAH30) | up to 30 days after surgery |
| 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. |
| 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) |
| Severity of postoperative Neurocognitive Disorders (NCD) | Includes major and mild postoperative NCD | within 1 year after surgery (long-term) |
| 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. | within 1 year after surgery (long-term) |
| Instrumental Daily Living Ability Scale (IADL) | IADL ≤6 is normal | within 1 year after surgery (long-term) |
| 1-year all-cause mortality | 1-year after surgery |
| Economic indicators |
| during the entire trial, an average of 1 year. |
| during hospitalization, an average of 7 days; through entire trial, an average of 1 year. |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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