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Recruiting NCT06452147

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

No phase Interventional Anesthesia Hip Fractures Dementia Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nerve block+standard anesthesia, Intravenous lidocaine+standard anesthesia, Bupivacaine liposome, Ultrasound-guided nerve block.
Who it may be relevant to
Registry conditions: Anesthesia, Hip Fractures, Dementia, Cognitive Impairment. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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 enhance anesthesia technique in perioperative neurocognitive function, as compared to standard anesthesia care in the elderly patients undergoing hip fracture

Interventions

  • Other Nerve block+standard anesthesia
    1. Receive nerve block as soon as possible after randomization; 2. Ultrasound-guided nerve block is recommended, with the iliacfascia block recommended as the blocking site; 3. It is recommended to use 1.33% bupivacaine liposome (long-acting), and the maximum dose should not exceed 133mg; or regular local anesthetic (bupivacaine or ropivacaine, etc.) with electronic analgesic pumping infusion; or multiple single injections of regular local anesthetics should be used to maintain the continuity of
  • Drug Intravenous lidocaine+standard anesthesia
    1. Subjects randomly assigned to Lidocaine Group (Group L) will be given ECG monitoring, oxygen saturation monitoring, blood pressure monitoring and an open intravenous route on the morning of the surgery. It is recommended to start the infusion of Lidocaine as soon as possible in the ward. 2. It is recommended to use portable electronic infusion pump for drug delivery. The loading dose is 1mg/kg, and the maintenance dose range is 1\~2mg/kg/h. The specific dosage is determined by the anesthesiol
  • Drug Bupivacaine liposome
    1.33% bupivacaine liposome
  • Device Ultrasound-guided nerve block
    Ultrasound-guided nerve block

Primary outcome measures

  • Incidence of Neurocognitive Disorders (NCD) events rate during the first 7 postoperative days [Time frame: during the first 7 postoperative days]
Secondary outcome measures (12)
  • Subtypes, severity, and duration of delirium [Time frame: during the first 7 postoperative days]
  • Neurocognitive decline in postoperative 7 days [Time frame: during the first 7 postoperative days]
  • Delayed neurocognitive recovery during 30 postoperative days [Time frame: during 30 postoperative days]
  • Hospital Anxiety and Depression Scale (HADs) [Time frame: during postoperative one year]
  • Acute pain before surgery [Time frame: 1, 2, 3 days after surgery]
  • Length of hospitalization [Time frame: days from admission to discharge, an average of 7 days]
  • Complications (except cognitive impairment) [Time frame: during postoperation 30 days]
  • Mortality [Time frame: 30 days]
  • Days at home up to 30 days after surgery (DAH30) [Time frame: up to 30 days after surgery]
  • Score of EuroQol Five Dimensions Questionnaire (EQ-5D) [Time frame: 1 week before fracture (review); 1 month; 6 months; and 12 months after surgery.]
  • Incidence of postoperative Neurocognitive Disorders (NCD) [Time frame: within 1 year after surgery (long-term)]
  • Severity of postoperative Neurocognitive Disorders (NCD) [Time frame: within 1 year after surgery (long-term)]

Eligibility criteria

Inclusion criteria

  • 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.
  • Additional inclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.

Exclusion criteria

  • 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.
  • Petients 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;
  • Additional exclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • The Second Affilliated Hospital and Yuying Children's Hospital of Wenzhou Medical Universi — Wenzhou

Identifiers

NCT: NCT06452147 · SAHoWMU-CR2024-03-112

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗