Effects of different anesthesia techniques on cognitive function in elderly hip fracture patients
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
NA · Second Affiliated Hospital of Wenzhou Medical University · NCT06452147
This study tests different anesthesia methods to see which one helps older patients with hip fractures keep their thinking skills sharp during and after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1860 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Wenzhou Medical University (other) |
| Locations | 1 site (Wenzhou, Zhejiang) |
| Trial ID | NCT06452147 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of various enhanced anesthesia techniques on perioperative neurocognitive function in elderly patients undergoing hip fracture surgery. It is a pragmatic, multi-arm, adaptive, open-label, multicenter randomized controlled platform trial comparing these techniques to standard anesthesia care. The interventions include nerve block combined with standard anesthesia, intravenous lidocaine with standard anesthesia, bupivacaine liposome, and ultrasound-guided nerve block. The goal is to determine which anesthesia method best preserves cognitive function in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 65 and older with unilateral hip fractures scheduled for surgical treatment.
Not a fit: Patients with multiple trauma or fractures, or those requiring multiple anesthetic surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive outcomes for elderly patients undergoing hip fracture surgery.
How similar studies have performed: Other studies have explored anesthesia techniques in similar populations, but this platform trial approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wenzhou, Zhejiang
- The Second Affilliated Hospital and Yuying Children's Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anesthesia, Hip Fractures, Dementia, Cognitive Impairment, Cognitive Decline