Clinical trial NCT06452147: Anesthesia and Perioperative Neurocognitive Disorders in the Elderly Patients Undergoing Hip Fracture Surgery Platform Trial (ANDES Platform Trial)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia
Hip Fractures
Dementia
Cognitive Impairment
Cognitive Decline
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: Zhejiang Provincial People's Hospital/ People's Hospital of Hangzhou Medical College
name: The 1st Affiliated Hospital of Wenzhou Medical University
name: Ningbo No.2 Hospital
name: Ningbo No.6 Hospital
name: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
name: Taizhou Hospital
name: Affiliated Wenling Hospital of Wenzhou Medical University
name: Lishui Country People's Hospital
name: The Fifth Hospital Affiliated to Wenzhou Medical University/ Lishui Central Hospital
name: Jinhua Municipal Central Hospital
name: Dongyang People's Hospital
name: People's Hospital of Quzhou
First posted: 2024-06-11
Enrollment: 1860
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Neurocognitive Disorders (NCD) events rate during the first 7 postoperative days
timeFrame: during the first 7 postoperative days
Secondary outcomes:
measure: Subtypes, severity, and duration of delirium
timeFrame: during the first 7 postoperative days
measure: Neurocognitive decline in postoperative 7 days
timeFrame: during the first 7 postoperative days
measure: Delayed neurocognitive recovery during 30 postoperative days
timeFrame: during 30 postoperative days
measure: Hospital Anxiety and Depression Scale (HADs)
timeFrame: during postoperative one year
measure: Acute pain before surgery
timeFrame: 1, 2, 3 days after surgery
measure: Length of hospitalization
timeFrame: days from admission to discharge, an average of 7 days
measure: Complications (except cognitive impairment)
timeFrame: during postoperation 30 days
measure: Mortality
timeFrame: 30 days
measure: Days at home up to 30 days after surgery (DAH30)
timeFrame: up to 30 days after surgery
measure: Score of EuroQol Five Dimensions Questionnaire (EQ-5D)
timeFrame: 1 week before fracture (review); 1 month; 6 months; and 12 months after surgery.
measure: Incidence of postoperative Neurocognitive Disorders (NCD)
timeFrame: within 1 year after surgery (long-term)
measure: Severity of postoperative Neurocognitive Disorders (NCD)
timeFrame: within 1 year after surgery (long-term)
measure: Type of postoperative Neurocognitive Disorders (NCD)
timeFrame: within 1 year after surgery (long-term)
measure: Instrumental Daily Living Ability Scale (IADL)
timeFrame: within 1 year after surgery (long-term)
measure: 1-year all-cause mortality
timeFrame: 1-year after surgery
measure: Economic indicators
timeFrame: during the entire trial, an average of 1 year.
Other outcomes:
measure: Incidence of adverse events
timeFrame: during hospitalization, an average of 7 days; through entire trial, an average of 1 year.
Locations:
city: Wenzhou
country: China
facility: The Second Affilliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: