Anesthesia, Hip Fractures, Dementia, Cognitive Impairment, Cognitive Decline
Conditions
Brief summary
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
Interventions
OTHERNerve block+standard anesthesia
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.
DRUGIntravenous 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. 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
Sponsors
Zhejiang Provincial People's Hospital/ People's Hospital of Hangzhou Medical College
The 1st Affiliated Hospital of Wenzhou Medical University
Ningbo No.2 Hospital
Ningbo No.6 Hospital
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Taizhou Hospital
Affiliated Wenling Hospital of Wenzhou Medical University
Lishui Country People's Hospital
The Fifth Hospital Affiliated to Wenzhou Medical University/ Lishui Central Hospital
Jinhua Municipal Central Hospital
Dongyang People's Hospital
People's Hospital of Quzhou
Second Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Aged 65 years and older. 2. Patients with unilateral hip fracture (including femoral neck, femoral head, intertrochanteric and subtrochanteric fractures) are scheduled for surgical treatment. 3. American Society of Anesthesiologists (ASA) physical status IV or below. 4. The patients or family members provide written informed consent. 5. Additional inclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.
Exclusion criteria
1. 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.); 2. Two or more anesthetic surgeries are required. 3. Petients with an obvious history of head trauma (such as loss of consciousness for more than 5 minutes, post-traumatic amnesia, etc.); 4. Patients who the researcher believes are unable to complete the assessment of primary outcome; 5. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Neurocognitive Disorders (NCD) events rate during the first 7 postoperative days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subtypes, severity, and duration of delirium | during the first 7 postoperative days | 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 | during the first 7 postoperative 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 | 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) | during postoperative one year | — |
| Acute pain before surgery | 1, 2, 3 days after surgery | Using Visual Analogue Scale (VAS) |
| Length of hospitalization | days from admission to discharge, an average of 7 days | — |
| Complications (except cognitive impairment) | during postoperation 30 days | including pulmonary infection, myocardial infarction, renal failure, gastrointestinal obstruction, etc. |
| Mortality | 30 days | — |
| Score of EuroQol Five Dimensions Questionnaire (EQ-5D) | 1 week before fracture (review); 1 month; 6 months; and 12 months after surgery. | using EQ-5D to measure quality of life |
| Incidence of postoperative Neurocognitive Disorders (NCD) | within 1 year after surgery (long-term) | 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). |
| Severity of postoperative Neurocognitive Disorders (NCD) | within 1 year after surgery (long-term) | Includes major and mild postoperative NCD |
| Type of postoperative Neurocognitive Disorders (NCD) | within 1 year after surgery (long-term) | 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. |
| Instrumental Daily Living Ability Scale (IADL) | within 1 year after surgery (long-term) | IADL ≤6 is normal |
| 1-year all-cause mortality | 1-year after surgery | — |
| Economic indicators | during the entire trial, an average of 1 year. | * Hospitalization fees; * Preoperative fees; * Anesthesia fees; * Surgery fees; * Post-operative fees; * Post-discharge medical expenses. |
| Days at home up to 30 days after surgery (DAH30) | up to 30 days after surgery | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | during hospitalization, an average of 7 days; through entire trial, an average of 1 year. | 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. |
Countries
China
Outcome results
None listed