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NCT06452147From ClinicalTrials.govRecruiting

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

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 Enhanced Anesthesia Technique in Perioperative Neurocognitive Function, as Compared to Standard Anesthesia Care in the Elderly Patients Undergoing Hip Fracture

  • Anesthesia
  • Hip Fractures
  • Dementia
  • Cognitive Impairment
  • Cognitive Decline

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Enrolment target
1,860
Started
19 June 2024
Main results due
30 July 2028
Study sites
13
Registry updated
25 September 2026

Can you take part?

  • Aged 65 years and over.
  • Open to any sex.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(13)

  • Dongyang People's Hospital

    Dongyang, Zhejiang, China

    Enrolling by invitation

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, China

    Enrolling by invitation

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang, China

    Recruiting

  • Lishui Central Hospital, the Fifth Hospital Affiliated to Wenzhou Medical University

    Lishui, Zhejiang, China

    Recruiting

  • Lishui People's Hospital

    Lishui, Zhejiang, China

    Recruiting

  • Ningbo No.2 Hospital

    Ningbo, Zhejiang, China

    Recruiting

  • Ningbo No.6 Hospital

    Ningbo, Zhejiang, China

    Recruiting

  • Quzhou People's Hospital

    Quzhou, Zhejiang, China

    Recruiting

  • Taizhou Central Hospital

    Taizhou, Zhejiang, China

    Enrolling by invitation

  • Zhejiang Taizhou Hospital

    Taizhou, Zhejiang, China

    Enrolling by invitation

  • The First People's Hospital of Wenling

    Wenling, Zhejiang, China

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, China

    Enrolling by invitation

  • The Second Affilliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, China

    Recruiting

Showing 13 of 13 sites. 8 of the 13 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06452147. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Anesthesia and Perioperative Neurocognitive Disorders in the Elderly Patients Undergoing Hip Fracture Surgery | Trialion