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
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: t
View:
• Aged 65 years and older.
• Patients with unilateral hip fracture (including femoral neck, femoral head, intertrochanteric and subtrochanteric fractures) are scheduled for surgical treatment.
• American Society of Anesthesiologists (ASA) physical status IV or below.
• The patients or family members provide written informed consent.
• Additional inclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.
Locations
Other Locations
China
The Second Affilliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Time Frame
Start Date:2024-06-19
Estimated Completion Date:2028-07-30
Participants
Target number of participants:1860
Treatments
Experimental: Nerve block + standard anesthesia protocol
(described in detail in sub-trial protocol 1)
Experimental: Intravenous infusion of lidocaine + standard anesthesia protocol
(described in detail in sub-trial protocol 2)
No_intervention: Standard anesthesia protocol
(If an intervention was found to be effective in the interim analysis, the executive committee will decide whether to add it to the standard anesthesia protocol.)
Collaborators: The 1st Affiliated Hospital of Wenzhou Medical University, Dongyang People's Hospital, Taizhou Hospital, Zhejiang Provincial People's Hospital/ People's Hospital of Hangzhou Medical College, Jinhua Municipal Central Hospital, Ningbo No.6 Hospital, Ningbo No.2 Hospital, Lishui Country People's Hospital, Affiliated Wenling Hospital of Wenzhou Medical University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Fifth Hospital Affiliated to Wenzhou Medical University/ Lishui Central Hospital, People's Hospital of Quzhou
Leads: Second Affiliated Hospital of Wenzhou Medical University