RecruitingNot Applicable

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

China1,860 participantsStarted 2024-06-19

Plain-language 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

Who can participate

Age range65 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.);
✕. Two or more anesthetic surgeries are required.
✕. Petients with an obvious history of head trauma (such as loss of consciousness for more than 5 minutes, post-traumatic amnesia, etc.);
✕. Patients who the researcher believes are unable to complete the assessment of primary outcome;
✕. Additional exclusion criteria may pertain to specific interventions and will be described in relevant sub-protocols.

What they're measuring

Incidence of Neurocognitive Disorders (NCD) events rate during the first 7 postoperative days

Timeframe: during the first 7 postoperative days

Trial details

NCT IDNCT06452147

SponsorSecond Affiliated Hospital of Wenzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-30

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