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

Anesthesia Clinical Trial

— ANDES platform  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452147
• Other study ID #: SAHoWMU-CR2024-03-112
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: July 30, 2028

Study information

• Verified date: June 2024
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1860
• Est. completion date: July 30, 2028
• Est. primary completion date: July 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Fractures, Bone
• Hip Fractures
• Neurocognitive Disorders

Intervention

Other:
• Nerve block+standard anesthesia
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.

Drug:
• Intravenous lidocaine+standard anesthesia
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
1.33% bupivacaine liposome

Device:
• Ultrasound-guided nerve block
Ultrasound-guided nerve block

Locations

Country	Name	City	State
China	The Second Affilliated Hospital and Yuying Children's Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (13)

Lead Sponsor

Collaborator

Second Affiliated Hospital of Wenzhou Medical University

Dongyang People's Hospital, 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 1st Affiliated Hospital of Wenzhou Medical University, The Fifth Hospital Affiliated to Wenzhou Medical University/ Lishui Central Hospital, The First People's Hospital of Wenling, Zhejiang Provincial People's Hospital/ People's Hospital of Hangzhou Medical College

Country where clinical trial is conducted

China, 

Outcome

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