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Efficacy and Safety of Remimazolam versus Dexmedetomidine for Sedation During Autologous Arteriovenous Fistula Creation Under Brachial Plexus Block in Patients with Uraemia: A Prospective Randomised Controlled Trial

Efficacy and Safety of Remimazolam versus Dexmedetomidine for Sedation During Autologous Arteriovenous Fistula Creation Under Brachial Plexus Block in Patients with Uraemia: A Prospective Randomised Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115430
Enrollment
Unknown
Registered
2025-12-25
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

uremia

Interventions

Dexmedetomidine group:Dexmedetomidine-Assisted Sedation

Sponsors

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

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

MeasureTime frame
The composite incidence of intraoperative sedation failure;

Secondary

MeasureTime 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

Public ContactJie Zhao

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

zhaojie567@163.com+86 15068829652

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026