uremia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years inclusive. 2. Diagnosed with end-stage renal disease requiring haemodialysis. 3. Scheduled for AVF surgery under brachial plexus anaesthesia. 4. American Society of Anaesthesiologists (ASA) physical status classification III-IV. 5. Voluntarily participates in this study and signs an informed consent form. Should a subject be unable to read and sign the informed consent form due to incapacity or other reasons, their legal guardian shall undertake the informed consent process and sign the form on their behalf. Should a subject lack the ability to read the informed consent form (e.g., illiterate subjects), a witness shall observe the informed consent process and sign the form.
Exclusion criteria
Exclusion criteria: 1. Individuals with known hypersensitivity to the investigational medicinal product or its constituents. 2. Vulnerable groups beyond the elderly/illiterate, including those with mental disorders, cognitive impairment, critically ill patients, pregnant women, etc. 3. Patients with severe cardiac conditions (e.g., acute myocardial infarction, major arrhythmias); severe cardiac conduction block, sick sinus syndrome, or left ventricular ejection fraction =5), difficult airway, or high risk of aspiration. 6. History of prolonged benzodiazepine use or alcohol/substance abuse. 7. Communication impairment preventing assessment cooperation. 8. Extremely unstable haemodynamics (e.g., MAP < 65 mmHg requiring high-dose vasoactive agents for maintenance).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite incidence of intraoperative sedation failure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Haemodynamic parameters;Patient comfort rating;Postoperative 24-hour AVF blood flow rate (mL/min);Patient and surgeon satisfaction scores.;Adverse events;The incidence of hypoxaemia.; | — |
Countries
China
Contacts
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University