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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,860
1. Receive nerve block as soon as possible after randomization; 2. Ultrasound-guided nerve block is recommended, with the iliacfascia block recommended as the blocking site; 3. 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.
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. 2. It is recommended to use portable electronic infusion pump for drug delivery. The loading dose is 1mg/kg, and the maintenance dose range is 1\~2mg/kg/h. 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.
1.33% bupivacaine liposome
Ultrasound-guided nerve block
The Second Affilliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
RECRUITINGIncidence of Neurocognitive Disorders (NCD) events rate during the first 7 postoperative days
Neurocognitive Disorders includes: 1. Postoperative delirium (POD) was mesaured by 3D-CAM; 2. 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).
Time frame: during the first 7 postoperative days
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.
Time frame: during the first 7 postoperative days
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.
Time frame: 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.
Time frame: during 30 postoperative days
Hospital Anxiety and Depression Scale (HADs)
Time frame: during postoperative one year
Acute pain before surgery
Using Visual Analogue Scale (VAS)
Time frame: 1, 2, 3 days after surgery
Length of hospitalization
Time frame: days from admission to discharge, an average of 7 days
Complications (except cognitive impairment)
including pulmonary infection, myocardial infarction, renal failure, gastrointestinal obstruction, etc.
Time frame: during postoperation 30 days
Mortality
Time frame: 30 days
Days at home up to 30 days after surgery (DAH30)
Time frame: up to 30 days after surgery
Score of EuroQol Five Dimensions Questionnaire (EQ-5D)
using EQ-5D to measure quality of life
Time frame: 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).
Time frame: within 1 year after surgery (long-term)
Severity of postoperative Neurocognitive Disorders (NCD)
Includes major and mild postoperative NCD
Time frame: 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.
Time frame: within 1 year after surgery (long-term)
Instrumental Daily Living Ability Scale (IADL)
IADL ≤6 is normal
Time frame: within 1 year after surgery (long-term)
1-year all-cause mortality
Time frame: 1-year after surgery
Economic indicators
* Hospitalization fees; * Preoperative fees; * Anesthesia fees; * Surgery fees; * Post-operative fees; * Post-discharge medical expenses.
Time frame: during the entire trial, an average of 1 year.
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