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NCT Number: NCT06998732

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

remimazolam sedation

Drug

remimazolam sedation

Primary outcomes

  1. ED95

    Time frame: 1 day

    the dose of Remimazolam that provides satisfactory sedation in 95% of patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Gang Chen

Other

Registry information

Official study title

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

Acronym: BCD

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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