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

Not Applicable

Recruiting

• Conditions: Cognitive Decline; Dementia; Anesthesia; Hip Fractures; Cognitive Impairment
• Interventions: Other: Nerve block+standard anesthesia; Drug: Intravenous lidocaine+standard anesthesia; Drug: Bupivacaine liposome; Device: Ultrasound-guided nerve block

• Registration Number: NCT06452147
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-06-10
• Study First Posted: 2024-06-11
• Study Start: 2024-06-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08
• Primary Completion: 2028-07-30
• Study Completion: 2028-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1860

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. Petients 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nerve block + standard anesthesia protocol	Bupivacaine liposome	(described in detail in sub-trial protocol 1)
Nerve block + standard anesthesia protocol	Nerve block+standard anesthesia	(described in detail in sub-trial protocol 1)
Nerve block + standard anesthesia protocol	Ultrasound-guided nerve block	(described in detail in sub-trial protocol 1)
Intravenous infusion of lidocaine + standard anesthesia protocol	Intravenous lidocaine+standard anesthesia	(described in detail in sub-trial protocol 2)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Score of EuroQol Five Dimensions Questionnaire (EQ-5D)	1 week before fracture (review); 1 month; 6 months; and 12 months after surgery.	using EQ-5D to measure quality of life
Instrumental Daily Living Ability Scale (IADL)	within 1 year after surgery (long-term)	IADL ≤6 is normal
Economic indicators	during the entire trial, an average of 1 year.	* Hospitalization fees; * Preoperative fees; * Anesthesia fees; * Surgery fees; * Post-operative fees; * Post-discharge medical expenses.
Neurocognitive decline in postoperative 7 days	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.
Incidence of postoperative Neurocognitive Disorders (NCD)	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).
Mortality	30 days
Type of postoperative Neurocognitive Disorders (NCD)	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.
Delayed neurocognitive recovery during 30 postoperative days	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.
Hospital Anxiety and Depression Scale (HADs)	during postoperative one year
Length of hospitalization	days from admission to discharge, an average of 7 days
Complications (except cognitive impairment)	during postoperation 30 days	including pulmonary infection, myocardial infarction, renal failure, gastrointestinal obstruction, etc.
Days at home up to 30 days after surgery (DAH30)	up to 30 days after surgery
Severity of postoperative Neurocognitive Disorders (NCD)	within 1 year after surgery (long-term)	Includes major and mild postoperative NCD
Subtypes, severity, and duration of delirium	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.
Acute pain before surgery	1, 2, 3 days after surgery	Using Visual Analogue Scale (VAS)
1-year all-cause mortality	1-year after surgery

Trial Locations

Locations (1)

The Second Affilliated Hospital and Yuying Children's Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China