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
Aged 65 years and older.
Patients with unilateral hip fracture (including femoral neck, femoral head, intertrochanteric and subtrochanteric fractures) are scheduled for surgical treatment.
American Society of Anesthesiologists (ASA) physical status IV or below.
The patients or family members provide written informed consent.
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.);
Two or more anesthetic surgeries are required.
Petients with an obvious history of head trauma (such as loss of consciousness for more than 5 minutes, post-traumatic amnesia, etc.);
Patients who the researcher believes are unable to complete the assessment of primary outcome;
Parallel
Nerve block+standard anesthesia
Other intervention1. 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.
Intravenous lidocaine+standard anesthesia
Drug1. 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.
Bupivacaine liposome
Drug1.33% bupivacaine liposome
Ultrasound-guided nerve block
DeviceUltrasound-guided nerve block
Incidence 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).
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.
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.
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.
Hospital Anxiety and Depression Scale (HADs)
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: 1. cardiopulmonary resuscitation; 2. Malignant hyperthermia or anaphylaxis; 3. Aspiration pneumonia ; 4. Epidural hematoma ; 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.
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Second Affiliated Hospital of Wenzhou Medical University
Lead sponsor
Zhejiang Provincial People's Hospital
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
Ningbo No.2 Hospital
Collaborator
Ningbo No.6 Hospital
Collaborator
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Collaborator
Taizhou Hospital
Collaborator
Affiliated Wenling Hospital of Wenzhou Medical University
Collaborator
Lishui Country People's Hospital
Collaborator
The Fifth Hospital Affiliated to Wenzhou Medical University/ Lishui Central Hospital
Collaborator
Jinhua Municipal Central Hospital
Collaborator
Dongyang People's Hospital
Collaborator
People's Hospital of Quzhou
Collaborator
