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

NCT06452147 | Recruiting DMC

• 1 other identifier: SAHoWMU-CR2024-03-112
• Study Type: interventional
• Target: 1,860
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia; Hip Fractures; Dementia; Cognitive Impairment; Cognitive Decline

Outcome Measures

Primary Outcomes (1)

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

  Neurocognitive Disorders includes: 1. Postoperative delirium (POD) was mesaured by 3D-CAM; 2. 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).

  during the first 7 postoperative days

Secondary Outcomes (16)

• Subtypes, severity, and duration of delirium

  during the first 7 postoperative days

• Neurocognitive decline in postoperative 7 days

  during the first 7 postoperative days

• Delayed neurocognitive recovery during 30 postoperative days

  during 30 postoperative days

• Hospital Anxiety and Depression Scale (HADs)

  during postoperative one year

• Acute pain before surgery

  1, 2, 3 days after surgery

Other Outcomes (1)

• Incidence of adverse events

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

Study Arms (3)

Nerve block + standard anesthesia protocol

EXPERIMENTAL

(described in detail in sub-trial protocol 1)

Other: Nerve block+standard anesthesia; Drug: Bupivacaine liposome; Device: Ultrasound-guided nerve block

Intravenous infusion of lidocaine + standard anesthesia protocol

EXPERIMENTAL

(described in detail in sub-trial protocol 2)

Drug: Intravenous lidocaine+standard anesthesia

Standard anesthesia protocol

NO INTERVENTION

(If an intervention was found to be effective in the interim analysis, the executive committee will decide whether to add it to the standard anesthesia protocol.)

Interventions

Nerve block+standard anesthesia OTHER

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 nerve block effect.

Nerve block + standard anesthesia protocol

Intravenous lidocaine+standard anesthesia DRUG

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 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.

Intravenous infusion of lidocaine + standard anesthesia protocol

Bupivacaine liposome DRUG

1.33% bupivacaine liposome

Nerve block + standard anesthesia protocol

Ultrasound-guided nerve block DEVICE

Ultrasound-guided nerve block

Nerve block + standard anesthesia protocol

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead
• Zhejiang Provincial People's Hospital/ People's Hospital of Hangzhou Medical College: collaborator
• The 1st Affiliated Hospital of Wenzhou Medical University: collaborator
• Ningbo No.2 Hospital: collaborator
• Ningbo No.6 Hospital: collaborator
• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University: collaborator
• Taizhou Hospital: collaborator
• Affiliated Wenling Hospital of Wenzhou Medical University: collaborator
• Lishui Country People's Hospital: collaborator
• The Fifth Hospital Affiliated to Wenzhou Medical University/ Lishui Central Hospital: collaborator
• Jinhua Municipal Central Hospital: collaborator
• Dongyang People's Hospital: collaborator
• People's Hospital of Quzhou: collaborator

Study Sites (1)

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

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Hip Fractures; Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 11, 2024
• Study Start: June 19, 2024
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)