NCT06452147

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,860 (estimated)
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Anesthesia
• Hip Fractures
• Dementia
• Cognitive Impairment
• Cognitive Decline

Interventions

Type	Name	Description
OTHER	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 nerve block effect.
DRUG	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 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.
DRUG	Bupivacaine liposome	1.33% bupivacaine liposome
DEVICE	Ultrasound-guided nerve block	Ultrasound-guided nerve block

Timeline

• Start date: 2024-06-19
• Primary completion: 2028-07-30
• Completion: 2028-07-30
• First posted: 2024-06-11
• Last updated: 2024-11-08

Locations

1 site across 1 country: China