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

Sponsor: Second Affiliated Hospital of Wenzhou Medical University • ClinicalTrials.gov ID: NCT06452147

Registry updated: 2026-09-25

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Description

The ANDES Platform Trial is a pragmatic, multicenter, adaptive randomized controlled platform trial in patients aged 65 years or older undergoing surgery for hip fracture. The trial evaluates whether enhanced anesthesia techniques reduce perioperative neurocognitive disorders compared with standard anesthesia care. The platform includes two randomization processes. In the first randomization, eligible participants are assigned to an active platform intervention-currently a preoperative regional nerve block or perioperative intravenous lidocaine infusion-or to a shared standard-anesthesia control. Participants for whom general anesthesia is planned may also enter a second, nested randomization and are assigned in a fixed 1:1 ratio to total intravenous anesthesia or volatile inhalational anesthesia, regardless of whether they participate in the first randomization. A non-surgical cognitive control cohort is included to characterize changes in cognitive test performance over time without exposure to surgery or study interventions. The Data Monitoring Committee reviews accumulating trial data and makes recommendations to the Trial Steering Committee, which determines whether platform interventions should continue, be modified, advance, or stop.

Interventions

Nerve block (Procedure)
Participants receive a preoperative regional nerve block as soon as possible after randomization. Ultrasound guidance is recommended, and fascia iliaca block is the recommended block technique.
Standard anesthesia care (Procedure)
Standard anesthesia care consists of routine general or regional anesthesia according to usual practice at each study center. Participants randomized to the shared control group do not receive protocol-specified trial interventions unless otherwise required by the Trial Steering Committee. Changes to standard anesthesia care are made in accordance with the prespecified adaptive decision framework. The independent Data Monitoring Committee reviews accumulating data and makes recommendations to the Trial Steering Committee, which makes the final platform decisions.
Bupivacaine liposome (Drug)
For participants randomized to the nerve block group, 1.33% bupivacaine liposome is recommended as a long-acting local anesthetic, with a maximum dose not exceeding 133 mg, to maintain the continuity of the nerve block effect.
Regular local anesthetic (Drug)
For participants randomized to the nerve block group, regular local anesthetic, such as bupivacaine or ropivacaine, may be used with continuous electronic analgesic pump infusion or multiple single injections to maintain the continuity of the nerve block effect.
Intravenous infusion of lidocaine (Drug)
Participants randomized to the lidocaine group receive ECG monitoring, oxygen saturation monitoring, blood pressure monitoring, and an open intravenous route on the morning of surgery. It is recommended to start the infusion of lidocaine as soon as possible in the ward. A portable electronic infusion pump is recommended for drug delivery. The loading dose is 1 mg/kg, and the maintenance dose range is 1 to 2 mg/kg/h. The specific dose is determined by the anesthesiologist according to 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 are recorded. Intravenous infusion of lidocaine should be administered under ECG monitoring.
Total intravenous anesthesia maintenance (Procedure)
Among participants who are eligible under the master protocol and for whom general anesthesia is planned, anesthetic maintenance may be assigned by the second nested randomization to total intravenous anesthesia maintenance in a 1:1 ratio. Total intravenous anesthesia maintenance is recommended to be mainly propofol-based, and analgesics such as remifentanil or fentanyl are recommended.
Volatile anesthesia maintenance (Procedure)
Among participants who are eligible under the master protocol and for whom general anesthesia is planned, anesthetic maintenance may be assigned by the second nested randomization to volatile anesthesia maintenance in a 1:1 ratio. Following intravenous induction, anesthesia maintenance mainly with sevoflurane or isoflurane is recommended.

Eligibility criteria

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. Patients 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. Additional exclusion criteria for the nerve block randomization: 1. Contraindications to nerve block, including allergy to local anesthetics, other contraindications specified in the applicable prescribing information, infection at the puncture site, or refusal to receive nerve block; 2. The investigator considers the participant unsuitable for nerve block because of conditions such as a history of severe peripheral neuropathy or severe coagulation dysfunction; 3. Receipt of nerve block before randomization during the current hospitalization. Additional exclusion criteria for the intravenous lidocaine randomization: 1. Allergy to lidocaine; 2. Severe hepatic impairment or renal insufficiency for which the investigator considers the participant unsuitable for enrollment. Eligibility Criteria for nonsurgical cognitive control participants: A nonsurgical cognitive control cohort may be recruited from emergency departments, outpatient clinics, inpatient wards, or the community for standardization of neurocognitive assessments. These participants will be matched as far as possible to surgical participants by age and education level. Except for criteria related to hip fracture surgery and trial interventions, the same general inclusion and exclusion criteria will apply. Nonsurgical cognitive control participants must not undergo surgery or anesthesia during the observation period; participants who undergo surgery during follow-up will be excluded from the nonsurgical cognitive control cohort.

Conditions

Anesthesia Hip Fractures Dementia Cognitive Impairment Cognitive Decline

Locations

Dongyang People's Hospital — Dongyang, Zhejiang, China
Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China
Jinhua Municipal Central Hospital — Jinhua, Zhejiang, China
Lishui Central Hospital, the Fifth Hospital Affiliated to Wenzhou Medical University — Lishui, Zhejiang, China
Lishui People's Hospital — Lishui, Zhejiang, China
Ningbo No.2 Hospital — Ningbo, Zhejiang, China
Ningbo No.6 Hospital — Ningbo, Zhejiang, China
Quzhou People's Hospital — Quzhou, Zhejiang, China
Taizhou Central Hospital — Taizhou, Zhejiang, China
Zhejiang Taizhou Hospital — Taizhou, Zhejiang, China
The First People's Hospital of Wenling — Wenling, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China
The Second Affilliated Hospital and Yuying Children's Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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