Anesthesia and Perioperative Neurocognitive Disorders in the Elderly Patients Undergoing Hip Fracture Surgery Platform Trial (ANDES Platform Trial)
ANDES platform
1 other identifier
interventional
1,860
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2024
CompletedFirst Posted
Study publicly available on registry
June 11, 2024
CompletedStudy Start
First participant enrolled
June 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2028
September 25, 2026
September 1, 2026
4.1 years
May 28, 2024
September 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Neurocognitive Disorders (NCD) events rate during the first 7 postoperative days
Neurocognitive Disorders includes: 1. Postoperative delirium (POD) was mesaured by 3D-CAM; 2. Neurocognitive decline was mesaured within 7 postoperative days by: Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA), and neuropsychological tests containing 5 cognitive domains (1. digit span test (DST); 2. trail making test (TMT); 3. Boston naming test (BNT); 4. auditory verbal learning test-Huashan version (AVLT-H)；5. clock drawing test (CDT).）, and active report of patients or family members). Neurocognitive function is assessed at screening, postoperative day 3, and postoperative day 7. If discharge occurs on postoperative day 5 or 6, the final assessment is performed on the day of discharge; if discharge occurs on postoperative day 4, no repeat cognitive assessment is performed. A participant with postoperative delirium and/or postoperative neurocognitive decline is classified as positive for the primary outcome.
during the first 7 postoperative days
Secondary Outcomes (17)
Subtypes, severity, and duration of delirium
during the first 7 postoperative days
Neurocognitive decline in postoperative 7 days
during the first 7 postoperative days
Delayed neurocognitive recovery during 30 postoperative days
Postoperative day 11 ± 3 days if the hospital stay exceeds 7 days, and postoperative day 30 ± 7 days.
Hospital Anxiety and Depression Scale (HADs)
At screening, postoperative day 5 ± 2 days, postoperative day 11 ± 3 days if the hospital stay exceeds 7 days, postoperative day 30 ± 7 days, and postoperative month 12 ± 1 month.
Acute pain before and after surgery
Before surgery and on postoperative days 1, 2, and 3.
- +12 more secondary outcomes
Other Outcomes (1)
Incidence of adverse events
From enrollment to hospital discharge, an average of 7 days.
Study Arms (3)
Nerve block
EXPERIMENTALParticipants receive standard anesthesia care plus preoperative regional nerve block, as described in sub-trial protocol 1. Participants in this arm who are planned to undergo general anesthesia may also enter the second nested randomization and be assigned in a 1:1 ratio to total intravenous anesthesia or volatile anesthesia maintenance.
Intravenous infusion of lidocaine
EXPERIMENTALParticipants receive standard anesthesia care plus perioperative intravenous lidocaine infusion, as described in sub-trial protocol 2. Participants in this arm who are planned to undergo general anesthesia may also enter the second nested randomization and be assigned in a 1:1 ratio to total intravenous anesthesia or volatile anesthesia maintenance.
Shared standard anesthesia care
ACTIVE COMPARATORParticipants receive standard anesthesia care. Participants for whom general anesthesia is planned may also enter the second nested randomization and be assigned in a fixed 1:1 ratio to total intravenous anesthesia maintenance or volatile anesthesia maintenance.
Interventions
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.
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 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.
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.
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.
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.
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
You may qualify if:
- Aged 65 years and older.
- Patients with unilateral hip fracture (including femoral neck, femoral head, intertrochanteric and subtrochanteric fractures) are scheduled for surgical treatment.
- American Society of Anesthesiologists (ASA) physical status IV or below.
- The patients or family members provide written informed consent.
You may not qualify if:
- 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.);
- Two or more anesthetic surgeries are required.
- Patients with an obvious history of head trauma (such as loss of consciousness for more than 5 minutes, post-traumatic amnesia, etc.);
- Patients who the researcher believes are unable to complete the assessment of primary outcome;
- 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;
- The investigator considers the participant unsuitable for nerve block because of conditions such as a history of severe peripheral neuropathy or severe coagulation dysfunction;
- Receipt of nerve block before randomization during the current hospitalization.
- Allergy to lidocaine;
- Severe hepatic impairment or renal insufficiency for which the investigator considers the participant unsuitable for enrollment.
- Eligibility Criteria for nonsurgical cognitive control participants:
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- First Affiliated Hospital of Wenzhou Medical Universitycollaborator
- Ningbo No.6 Hospitalcollaborator
- Zhejiang Provincial People's Hospitalcollaborator
- Second Affiliated Hospital of Wenzhou Medical Universitylead
- Ningbo No.2 Hospitalcollaborator
- Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical Universitycollaborator
- Taizhou Hospitalcollaborator
- Affiliated Wenling Hospital of Wenzhou Medical Universitycollaborator
- Lishui Country People's Hospitalcollaborator
- The Fifth Hospital Affiliated to Wenzhou Medical University/ Lishui Central Hospitalcollaborator
- Jinhua Municipal Central Hospitalcollaborator
- Dongyang People's Hospitalcollaborator
- People's Hospital of Quzhoucollaborator
Study Sites (13)
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, 325000, China
The Second Affilliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ting Li, MD, PhD
Second Affiliated Hospital of Wenzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Participants and treating clinicians are not blinded because of the nature of the interventions. Outcome assessors are blinded to treatment allocation. Statistical analyses are conducted using blinded treatment codes.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2024
First Posted
June 11, 2024
Study Start
June 19, 2024
Primary Completion (Estimated)
July 30, 2028
Study Completion (Estimated)
October 31, 2028
Last Updated
September 25, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Available within 1 year after study completion.
- Access Criteria
- Requests should be submitted to the principal investigator or data coordinating center.
Within 1 year after study completion, study data and related documentation will be made available upon request to the principal investigator or data coordinating center. The documentation will include annotated case report forms, descriptions of the structure, variables, and content of each dataset, the final protocol, study procedures, data collection forms, descriptions of variable recoding, and lists and links to major publications. Key datasets will be archived as appropriate.