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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,860
- 试验地点
- 1
- 主要终点
- Incidence of Neurocognitive Disorders (NCD) events rate during the first 7 postoperative days
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •Additional inclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.
排除标准
- •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;
- •Additional exclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.
研究组 & 干预措施
Nerve block + standard anesthesia protocol
(described in detail in sub-trial protocol 1)
干预措施: Nerve block+standard anesthesia (Other)
Nerve block + standard anesthesia protocol
(described in detail in sub-trial protocol 1)
干预措施: Bupivacaine liposome (Drug)
Nerve block + standard anesthesia protocol
(described in detail in sub-trial protocol 1)
干预措施: Ultrasound-guided nerve block (Device)
Intravenous infusion of lidocaine + standard anesthesia protocol
(described in detail in sub-trial protocol 2)
干预措施: Intravenous lidocaine+standard anesthesia (Drug)
结局指标
主要结局
Incidence of Neurocognitive Disorders (NCD) events rate during the first 7 postoperative days
时间窗: 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).
次要结局
- Score of EuroQol Five Dimensions Questionnaire (EQ-5D)(1 week before fracture (review); 1 month; 6 months; and 12 months after surgery.)
- Instrumental Daily Living Ability Scale (IADL)(within 1 year after surgery (long-term))
- Economic indicators(during the entire trial, an average of 1 year.)
- Neurocognitive decline in postoperative 7 days(during the first 7 postoperative days)
- Incidence of postoperative Neurocognitive Disorders (NCD)(within 1 year after surgery (long-term))
- Mortality(30 days)
- Type of postoperative Neurocognitive Disorders (NCD)(within 1 year after surgery (long-term))
- Days at home up to 30 days after surgery (DAH30)(up to 30 days after surgery)
- Severity of postoperative Neurocognitive Disorders (NCD)(within 1 year after surgery (long-term))
- Delayed neurocognitive recovery during 30 postoperative days(during 30 postoperative days)
- Hospital Anxiety and Depression Scale (HADs)(during postoperative one year)
- Length of hospitalization(days from admission to discharge, an average of 7 days)
- Complications (except cognitive impairment)(during postoperation 30 days)
- Acute pain before surgery(1, 2, 3 days after surgery)
- 1-year all-cause mortality(1-year after surgery)
- Subtypes, severity, and duration of delirium(during the first 7 postoperative days)