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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1860 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-19

Study Completion Date

2028-07-30

Brief Summary

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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

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Detailed Description

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Conditions

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Anesthesia Hip Fractures Dementia Cognitive Impairment Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Nerve block + standard anesthesia protocol

(described in detail in sub-trial protocol 1)

Group Type EXPERIMENTAL

Nerve block+standard anesthesia

Intervention Type OTHER

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.

Bupivacaine liposome

Intervention Type DRUG

1.33% bupivacaine liposome

Ultrasound-guided nerve block

Intervention Type DEVICE

Ultrasound-guided nerve block

Intravenous infusion of lidocaine + standard anesthesia protocol

(described in detail in sub-trial protocol 2)

Group Type EXPERIMENTAL

Intravenous lidocaine+standard anesthesia

Intervention Type DRUG

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.

Standard anesthesia protocol

(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.)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type DRUG

Bupivacaine liposome

1.33% bupivacaine liposome

Intervention Type DRUG

Ultrasound-guided nerve block

Intervention Type DEVICE

Eligibility Criteria

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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.

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;

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes