🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06452147
Recruiting Not applicable

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

NCT06452147 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Phase
Not applicable
Started
2024-06-19
Last updated
2024-11-08

Condition(s) studied

AnesthesiaHip FracturesDementiaCognitive ImpairmentCognitive Decline

Investigational drug(s) / intervention(s)

Nerve block+standard anesthesiaIntravenous lidocaine+standard anesthesiaBupivacaine liposomeUltrasound-guided nerve block

Nerve block+standard anesthesia: 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.

Intravenous lidocaine+standard anesthesia: 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.

Bupivacaine liposome: 1.33% bupivacaine liposome

Ultrasound-guided nerve block: Ultrasound-guided nerve block

Study 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

Sex
ALL
Min age
65 Years
Max age
Healthy volunteers
Accepted
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 outcome measure(s)

Trial sites (1)

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

More Second Affiliated Hospital of Wenzhou Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06452147 on ClinicalTrials.gov ↗ ← All trials in China