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Search / Trial NCT06998732

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

Launched by GANG CHEN · May 22, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Biased Coin Design Uremia Remimazolam Ed95

ClinConnect Summary

This clinical trial is studying a medication called remimazolam, which is used to help patients relax and feel comfortable during a specific type of surgery called arteriovenous fistula creation. This surgery is often needed for patients with kidney issues (uremia) who require dialysis. The goal of the study is to find out the proper amount of remimazolam that helps most patients feel relaxed during the procedure.

To participate in this study, patients need to be between 18 and 65 years old and be scheduled for surgery under local anesthesia. They should also be in generally good health, as determined by a medical assessment. Individuals with certain health conditions, such as severe heart or lung problems, or those who have allergies to remimazolam, cannot take part in this trial. If eligible, participants can expect to receive remimazolam before their surgery and will be monitored throughout the process to ensure their safety and comfort. This study is currently not recruiting participants yet, but it will help improve sedation practices for future surgeries.

Gender

ALL

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.

About Gang Chen

Gang Chen is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With expertise in designing and managing clinical studies across various therapeutic areas, Gang Chen focuses on innovative methodologies and rigorous protocols to ensure the integrity and reliability of trial results. Their collaborative approach fosters partnerships with healthcare professionals and research institutions, aiming to address unmet medical needs and contribute to the development of transformative therapies. Through a patient-centered lens, Gang Chen prioritizes ethical considerations and regulatory compliance, striving to enhance the standards of clinical research.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported