Menu
Not yet recruiting NCT06998732

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

Phase IV Interventional Uremia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: remimazolam sedation.
Who it may be relevant to
Registry conditions: Uremia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug remimazolam sedation
    remimazolam sedation

Primary outcome measures

  • ED95 [Time frame: 1 day]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06998732 · remimazolam · 13152

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗