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

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

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

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital/ People's Hospital of Hangzhou Medical College

  collaborator UNKNOWN

• The 1st Affiliated Hospital of Wenzhou Medical University

  collaborator UNKNOWN

• Ningbo No.2 Hospital

  collaborator OTHER

• Ningbo No.6 Hospital

  collaborator OTHER

• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  collaborator OTHER

• Taizhou Hospital

  collaborator OTHER

• Affiliated Wenling Hospital of Wenzhou Medical University

  collaborator OTHER

• Lishui Country People's Hospital

  collaborator OTHER

• The Fifth Hospital Affiliated to Wenzhou Medical University/ Lishui Central Hospital

  collaborator UNKNOWN

• Jinhua Municipal Central Hospital

  collaborator OTHER

• Dongyang People's Hospital

  collaborator OTHER

• People's Hospital of Quzhou

  collaborator OTHER

• Second Affiliated Hospital of Wenzhou Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-06-19

Primary Completion

2028-07-30

Completion

2028-07-30

Countries

• China

Study Locations