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Anesthesia and Perioperative Neurocognitive Disorders in Elderly Patients Undergoing Hip Fracture Surgery Platform Trial (ANDES): A Multi-arm, Adaptive, Open-label, Multicenter Randomized Controlled Platform Trial Comparing Enhanced Anesthesia Techniques to Standard Care
Led by Second Affiliated Hospital of Wenzhou Medical University · Updated on 2024-11-08
1860
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital of Wenzhou Medical University
Lead Sponsor
Z
Zhejiang Provincial People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating different enhanced anesthesia techniques to understand their effects on brain function after surgery in elderly patients undergoing hip fracture repair. This trial aims to compare these new anesthesia methods with the standard care to see if they influence the rate of neurocognitive disorders during the first week after surgery. The study is designed as a multi-arm, adaptive, open-label, randomized controlled platform trial involving multiple centers and elderly patients aged 65 and older. Participants will be randomly assigned to one of three groups: standard anesthesia care, standard anesthesia combined with a nerve block, or standard anesthesia combined with intravenous lidocaine infusion. The nerve block is performed preferably with ultrasound guidance and involves long-acting local anesthetics, while the lidocaine infusion starts before surgery and continues until the patient leaves the post-anesthesia care unit. If any intervention shows effectiveness during interim analyses, it may be added to the standard care protocol. During the study, participants will be monitored for neurocognitive disorders and other complications up to one year after surgery. Assessments include the incidence and severity of delirium and cognitive decline, pain levels, hospital stay length, anxiety and depression scales, quality of life questionnaires, and mortality rates. The primary outcome is the rate of neurocognitive disorder events within the first seven days post-surgery. Follow-up will continue for up to one year to evaluate long-term cognitive outcomes and overall recovery.
CONDITIONS
Brief Title
Anesthesia and Perioperative Neurocognitive Disorders in the Elderly Patients Undergoing Hip Fracture Surgery Platform Trial (ANDES Platform Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 65 years and older
- Patients with unilateral hip fracture scheduled for surgical treatment
- American Society of Anesthesiologists (ASA) physical status IV or below
- Patients or family members provide written informed consent
- Additional criteria related to specific interventions may apply as described in sub-protocols
You will not qualify if you...
- Patients with multiple trauma or fractures except minor injuries not affecting recovery
- Patients requiring two or more anesthetic surgeries
- History of significant head trauma such as loss of consciousness over 5 minutes
- Inability to complete primary outcome assessment as judged by the researcher
- Additional exclusion criteria may apply as described in sub-protocols
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive one of the anesthesia protocols during hip fracture surgery, which may include nerve block with standard anesthesia, intravenous lidocaine with standard anesthesia, or standard anesthesia alone.
1 visit on the day of surgery (in-person)
Duration - 30 days after surgery
Participants are monitored for neurocognitive disorders and other outcomes during the first 30 days after surgery, including assessments of pain, complications, and recovery.
Multiple visits during the first 7 days post-surgery and additional assessments up to 30 days
Duration - Up to 1 year after surgery
Participants are followed for up to 1 year after surgery to assess neurocognitive function, quality of life, mortality, and economic outcomes.
Follow-up visits at 1 month, 6 months, and 12 months after surgery
Trial Site Locations
Total: 1 location
1
The Second Affilliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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