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

RecruitingNAAges 65 Years - anyAllSecond Affiliated Hospital of Wenzhou Medical Uniโ€ฆ
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In plain words

What the trial is, and whether it could suit you

The ANDES Platform Trial is a pragmatic, multicenter, adaptive randomized controlled platform trial in patients aged 65 years or older undergoing surgery for hip fracture. The trial evaluates whether enhanced anesthesia techniques reduce perioperative neurocognitive disorders compared with standard anesthesia care. The platform includes two randomization processes. In the first randomization, eligible participants are assigned to an active platform intervention-currently a preoperative regional nerve block or perioperative intravenous lidocaine infusion-or to a shared standard-anesthesia control. Participants for whom general anesthesia is planned may also enter a second, nested randomization and are assigned in a fixed 1:1 ratio to total intravenous anesthesia or volatile inhalational anesthesia, regardless of whether they participate in the first randomization. A non-surgical cogniti

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๐Ÿ“‹ Eligibility rules (as published)
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. Patients 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. Additional exclusion criteria for the nerve block randomization: 1. Contraindications to nerve block, including allergy to local anesthetics, other contraindications specified in the applicable prescribing information, infection at the puncture site, or refusal to receive nerve block; 2. The investigator considers the participant unsuitable for nerve block because of conditions such as a history of severe peripheral neuropathy or severe coagulation dysfunction; 3. Receipt of nerve block before randomization during the current hospitalization. Additional exclusion criteria for the intravenous lidocaine randomization: 1. Allergy to lidocaine; 2. Severe hepatic impairment or renal insufficiency for which the investigator considers the participant unsuitable for enrollment. Eligibility Criteria for nonsurgical cognitive control participants: A nonsurgical cognitive control cohort may be recruited from emergency departments, outpatient clinics, inpatient wards, or the community for standardization of neurocognitive assessments. These participants will be matched as far as possible to surgical participants by age and education level. Except for criteria related to hip fracture surgery and trial interventions, the same general inclusion and exclusion criteria will apply. Nonsurgical cognitive control participants must not undergo surgery or anesthesia during the observation period; participants who undergo surgery during follow-up will be excluded from the nonsurgical cognitive control cohort.
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What it tests

  • Nerve block
  • Standard anesthesia care
  • Bupivacaine liposome
  • Regular local anesthetic
  • Intravenous infusion of lidocaine
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Where

13 sites
Dongyang People's Hospital
Dongyang, China
Zhejiang Provincial People's Hospital
Hangzhou, China
Jinhua Municipal Central Hospital
Jinhua, China
Lishui Central Hospital, the Fifth Hospital Affiliated to Wenzhou Medical University
Lishui, China
Lishui People's Hospital
Lishui, China
Ningbo No.2 Hospital
Ningbo, China
Ningbo No.6 Hospital
Ningbo, China
Quzhou People's Hospital
Quzhou, China

โ€ฆand 5 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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