Anesthesia and Perioperative Neurocognitive Disorders in the Elderly Patients Undergoing Hip Fracture Surgery Platform Trial (ANDES Platform Trial)

Официальное название

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

Обзор

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

Вмешательства

• Другое Nerve 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
• Препарат Intravenous 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 anesthesiol
• Препарат Bupivacaine liposome
  1.33% bupivacaine liposome
• Устройство Ultrasound-guided nerve block
  Ultrasound-guided nerve block

Первичные конечные точки

• Incidence of Neurocognitive Disorders (NCD) events rate during the first 7 postoperative days [Срок оценки: during the first 7 postoperative days]

Вторичные конечные точки (12)

• Subtypes, severity, and duration of delirium [Срок оценки: during the first 7 postoperative days]
• Neurocognitive decline in postoperative 7 days [Срок оценки: during the first 7 postoperative days]
• Delayed neurocognitive recovery during 30 postoperative days [Срок оценки: during 30 postoperative days]
• Hospital Anxiety and Depression Scale (HADs) [Срок оценки: during postoperative one year]
• Acute pain before surgery [Срок оценки: 1, 2, 3 days after surgery]
• Length of hospitalization [Срок оценки: days from admission to discharge, an average of 7 days]
• Complications (except cognitive impairment) [Срок оценки: during postoperation 30 days]
• Mortality [Срок оценки: 30 days]
• Days at home up to 30 days after surgery (DAH30) [Срок оценки: up to 30 days after surgery]
• Score of EuroQol Five Dimensions Questionnaire (EQ-5D) [Срок оценки: 1 week before fracture (review); 1 month; 6 months; and 12 months after surgery.]
• Incidence of postoperative Neurocognitive Disorders (NCD) [Срок оценки: within 1 year after surgery (long-term)]
• Severity of postoperative Neurocognitive Disorders (NCD) [Срок оценки: within 1 year after surgery (long-term)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• The Second Affilliated Hospital and Yuying Children's Hospital of Wenzhou Medical Universi — Wenzhou

Идентификаторы

NCT: NCT06452147 · SAHoWMU-CR2024-03-112

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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