NCT06998732

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2025

Shorter than P25 for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

May 14, 2025

Last Update Submit

May 22, 2025

Conditions

Uremia

Keywords

Biased Coin DesignuremiaremimazolamED95

Outcome Measures

Primary Outcomes (1)

  • ED95

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

    1 day

Study Arms (1)

remimazolam group

EXPERIMENTAL

Measurement of ED95 in uremic patients sedated with remimazolam using the BCD method

Drug: remimazolam sedation

Interventions

remimazolam sedationDRUG

remimazolam sedation

remimazolam group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uremia

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Jie Zhao

CONTACT

8615068829652zhaojie1014@zju.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

May 14, 2025

First Posted

May 31, 2025

Study Start

June 1, 2025

Primary Completion

September 30, 2025

Study Completion

October 31, 2025

Last Updated

May 31, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL