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The Efficacy and Safety of Remimazolam for Sedation During Arteriovenous Fistula Balloon Dilatation in Patients with Uraemia: A Randomised Controlled Trial

The Efficacy and Safety of Remimazolam for Sedation During Arteriovenous Fistula Balloon Dilatation in Patients with Uraemia: A Randomised Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115527
Enrollment
Unknown
Registered
2025-12-28
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

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 18–80 years inclusive. 2. Diagnosed with end-stage renal disease requiring haemodialysis. 3.Scheduled for AVF-PTA under local 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 consent form due to incapacity or other reasons, their legal guardian shall undertake the informed consent process and sign the consent form on their behalf. Should a subject lack the ability to read the consent form (e.g., illiterate subjects), a witness shall observe the informed consent process and sign the consent form.

Exclusion criteria

Exclusion criteria: 1. allergy to remazolam or benzodiazepines;. 2. vulnerable groups other than the elderly/illiterate, including the mentally ill, cognitively impaired, critically ill patients, pregnant women, etc. 3. patients with severe hepatic failure or unable to tolerate regional anaesthesia; 4. difficult airway or high risk of reflux aspiration. 5. severe obstructive sleep apnoea (STOP-Bang score >=5). 6. mental illness or communication disorders that prevent co-operation with the assessment. 7. Extremely unstable haemodynamics (e.g. MAP < 65 mmHg requiring high doses of vasoactive drugs); 8. Severe cardiac disease (e.g. acute myocardial infarction, severe arrhythmia).

Design outcomes

Primary

MeasureTime frame
Patient Satisfaction Rating;

Secondary

MeasureTime frame
Surgical satisfaction;Sedation depth;Pain assessment;Recovery status;Adverse events;Safety;

Countries

China

Contacts

Public Contactzhaojie

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

zhaojie567@163.com+86 150 6882 9652

Outcome results

None listed

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