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

Second Affiliated Hospital of Wenzhou Medical University

Status: Enrolling

Conditions: Hip Fractures; Cognitive Impairment; Cognitive Decline; Dementia; Anesthesia

Treatments: Device: Ultrasound-guided nerve block; Drug: Bupivacaine liposome; Other: Nerve block+standard anesthesia; Drug: Intravenous lidocaine+standard anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06452147

SAHoWMU-CR2024-03-112

Details and patient eligibility

About

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

Enrollment: 1,860 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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 exclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,860 participants in 3 patient groups

Nerve block + standard anesthesia protocol

Experimental group

Description:

(described in detail in sub-trial protocol 1)

Treatment:

Other: Nerve block+standard anesthesia

Drug: Bupivacaine liposome

Device: Ultrasound-guided nerve block

Intravenous infusion of lidocaine + standard anesthesia protocol

Experimental group

Description:

(described in detail in sub-trial protocol 2)

Treatment:

Drug: Intravenous lidocaine+standard anesthesia

Standard anesthesia protocol

No Intervention group

Description:

(If an intervention was found to be effective in the interim analysis, the executive committee will decide whether to add it to the standard anesthesia protocol.)