BCD to Measure the ED95 of Remimazolam-Assisted Sedation in Arteriovenous Fistula Creation Surgery

Using Biased Coin Design (BCD) to Measure the ED95 of Remimazolam-Assisted Sedation in Arteriovenous Fistula Creation Surgery

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06998732

Acronym

BCD

Enrollment

Registered

2025-05-31

Start date

2025-06-01

Completion date

2025-10-31

Last updated

2025-05-31

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

Conditions

Uremia

Keywords

Biased Coin Design, uremia, remimazolam, ED95

Brief summary

This study intends to measure the ED95 of remimazolam-assisted sedation in arteriovenous fistula creation by BCD.

Detailed description

Operative venous fistula (AVF) under local anaesthesia is a common surgical procedure for long-term haemodialysis patients. A common surgical procedure for patients with renal failure on dialysis. However, due to the long duration of the procedure, patients are prone to anxiety and nervousness that Especially if it is difficult to keep quiet during the operation, it may lead to blood pressure fluctuation and other complications, affecting the operation's smooth progress of the procedure. Moderate sedation is particularly important in this type of surgery, as it can effectively relieve the patient's tension and stabilise vital signs, It can effectively relieve the patient's tension, stabilise vital signs and reduce the patient's discomfort, thus contributing to the successful completion of the operation.This study intends to measure the ED95 of remazolam-assisted sedation in arteriovenous fistula creation by BCD. This will provide a scientific basis for anaesthetic drug selection in uremic patients.

Interventions

DRUGremimazolam sedation

remimazolam sedation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 18-65 years old (including borderline values). * Elective surgical patients under local anaesthesia for operation of AVF * Voluntary participation in this study and signing of informed consent. * American Society of Anesthesiologists (ASA) classification \< Grade IV. * BMI range: 18-28kg/m2 (including borderline values).

Exclusion criteria

* hypersensitivity to remimazolam or benzodiazepines. * patients with severe cardiac, pulmonary, neurological diseases or liver failure. -- Preoperative use of sedative drugs, anticonvulsants, etc. * patients who cannot cooperate with postoperative recovery or follow-up. * vulnerable groups, including those with mental illness, cognitive impairment, critically ill patients, pregnant women, illiterates, etc.

Design outcomes

Primary

Measure	Time frame	Description
ED95	1 day	the dose of Remimazolam that provides satisfactory sedation in 95% of patients.

Contacts

Primary ContactJie Zhao

zhaojie1014@zju.edu.cn8615068829652

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026