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

Study acronym: ANDES platform
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Trial sites expanded: 1 → 13 locations Show 6 more changesShow less
    • Study completion pushed from Jul 30, 2028 to Oct 31, 2028
    • Interventions modified
    • Eligibility criteria expanded, about 208 words
    • Secondary endpoints: 16 to 17
    • Study description expanded, about 299 words
    • Collaborators: details revised at 5 of 12 entries
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 30, 2024 to Jun 19, 2024
    • Site details revised
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06452147
Lead Sponsor Second Affiliated Hospital of Wenzhou Medical University
Collaborators: Zhejiang Provincial People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Ningbo No.2 Hospital, Ningbo No.6 Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Taizhou Hospital, Affiliated Wenling Hospital of Wenzhou Medical University, Lishui Country People's Hospital, The Fifth Hospital Affiliated to Wenzhou Medical University/ Lishui Central Hospital, Jinhua Municipal Central Hospital, Dongyang People's Hospital, People's Hospital of Quzhou
Conditions
(from sponsor)
Anesthesia, Hip Fractures, Dementia, Cognitive Impairment, Cognitive Decline
Related terms Cognitive Dysfunction, Dementia, Hip Fractures
Enrollment 1,860 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov