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NCT Number: NCT06452147

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

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Key information

Conditions

Anesthesia Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Decline Cognitive Dysfunction Cognitive Impairment Dementia Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Mental Disorders Nervous System Diseases Neurocognitive Disorders Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Wenzhou, Zhejiang, 325000, China

Location status: Recruiting

Location contact

Bingwu Huang, PhD

SUB_INVESTIGATOR

Ting Li, PhD

CONTACT

[email protected]

13587876896

Ting Li, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nerve block+standard anesthesia

Other
  • Receive nerve block as soon as possible after randomization;
  • Ultrasound-guided nerve block is recommended, with the iliacfascia block recommended as the blocking site;
  • 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 nerve block effect.

Intravenous lidocaine+standard anesthesia

Drug
  • 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.
  • 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 anesthesiologist based on 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 should be recorded.

Bupivacaine liposome

Drug

1.33% bupivacaine liposome

Ultrasound-guided nerve block

Device

Ultrasound-guided nerve block

Primary outcomes

  1. Incidence of Neurocognitive Disorders (NCD) events rate during the first 7 postoperative days

    Time frame: during the first 7 postoperative days

    Neurocognitive Disorders includes:

    • Postoperative delirium (POD) was mesaured by 3D-CAM;
    • 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 latitudes (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).

Secondary outcomes

  1. Subtypes, severity, and duration of delirium

    Time frame: during the first 7 postoperative days

    Using CAM-S, and in units of days from the onset of delirium symptoms to the disappearance of symptoms or when the patient is discharged.

  2. Neurocognitive decline in postoperative 7 days

    Time frame: during the first 7 postoperative days

    Neurocognitive decline was mesaured by: Mini-Mental State Examination (MMSE) or Montreal Cognitive Assessment (MoCA), or neuropsychological tests containing 5 cognitive latitudes (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).）, or active report of patients or family members.

  3. Delayed neurocognitive recovery during 30 postoperative days

    Time frame: during 30 postoperative days

    This was mesaured by: Mini-Mental State Examination (MMSE) or Montreal Cognitive Assessment (MoCA), or neuropsychological tests containing 5 cognitive latitudes (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).）, or active report of patients or family members.

  4. Hospital Anxiety and Depression Scale (HADs)

    Time frame: during postoperative one year

  5. Acute pain before surgery

    Time frame: 1, 2, 3 days after surgery

    Using Visual Analogue Scale (VAS)

  6. Length of hospitalization

    Time frame: days from admission to discharge, an average of 7 days

  7. Complications (except cognitive impairment)

    Time frame: during postoperation 30 days

    including pulmonary infection, myocardial infarction, renal failure, gastrointestinal obstruction, etc.

  8. Mortality

    Time frame: 30 days

  9. Days at home up to 30 days after surgery (DAH30)

    Time frame: up to 30 days after surgery

  10. Score of EuroQol Five Dimensions Questionnaire (EQ-5D)

    Time frame: 1 week before fracture (review); 1 month; 6 months; and 12 months after surgery.

    using EQ-5D to measure quality of life

  11. Incidence of postoperative Neurocognitive Disorders (NCD)

    Time frame: within 1 year after surgery (long-term)

    This was mesaured within 7 postoperative days by: Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA), and neuropsychological tests containing 5 cognitive latitudes (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).

  12. Severity of postoperative Neurocognitive Disorders (NCD)

    Time frame: within 1 year after surgery (long-term)

    Includes major and mild postoperative NCD

  13. Type of postoperative Neurocognitive Disorders (NCD)

    Time frame: within 1 year after surgery (long-term)

    Using Hachinski Ischemic Scale (HIS) combined with clinical symptoms and auxiliary examination to mesaure the type of postoperative NCD. HIS ≥7 was considered as vascular cognitive impairment.

  14. Instrumental Daily Living Ability Scale (IADL)

    Time frame: within 1 year after surgery (long-term)

    IADL ≤6 is normal

  15. 1-year all-cause mortality

    Time frame: 1-year after surgery

  16. Economic indicators

    Time frame: during the entire trial, an average of 1 year.

    • Hospitalization fees;
    • Preoperative fees;
    • Anesthesia fees;
    • Surgery fees;
    • Post-operative fees;
    • Post-discharge medical expenses.

Other outcomes

  1. Incidence of adverse events

    Time frame: during hospitalization, an average of 7 days; through entire trial, an average of 1 year.

    We will collect the following known potential risks of general and local anesthesia from the start of the intervention to the subject's discharge and assess the overall incidence:

    • cardiopulmonary resuscitation;
    • Malignant hyperthermia or anaphylaxis;
    • Aspiration pneumonia ;
    • Epidural hematoma ;
    • Patients who did not need mechanical ventilation before surgery continued with unplanned mechanical ventilation for more than 6 hours after surgery; 7) Other adverse events during postoperative hospitalization.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Collaborators

  • Affiliated Wenling Hospital of Wenzhou Medical University
  • Dongyang People's Hospital
  • First Affiliated Hospital of Wenzhou Medical University
  • Jinhua Municipal Central Hospital
  • Lishui Country People's Hospital
  • Ningbo No.2 Hospital
  • Ningbo No.6 Hospital
  • People's Hospital of Quzhou
  • Taizhou Hospital
  • Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
  • The Fifth Hospital Affiliated to Wenzhou Medical University/ Lishui Central Hospital
  • Zhejiang Provincial People's Hospital

Registry information

Official study 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

Acronym: ANDES platform

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jun 11, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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