ClinicalTrials.gg
CompletedNCT06998732BCDUpdated Oct 27, 2026

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

An interventional study of remimazolam sedation in Chronic Kidney Failure, sponsored by Sir Run Run Shaw Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Sir Run Run Shaw Hospital · Not applicable, Interventional, and Treatment

Updated Oct 27, 2026Now CompletedFirst site in China+8 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Chronic Kidney Failure

Keywords

  • Biased Coin Design
  • uremia
  • remimazolam
  • ED95
03

In context

Kidney Failure, Chronic

2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.

This study's enrollment of 50 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Sir Run Run Shaw Hospital is the lead sponsor of 135 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 27, 2026. See what changed

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • (ASA) physical status I-III
  • range: 18-28kg/m2 (including borderline values).

Exclusion criteria

Exclusion Criteria:

  • 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, etc.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    remimazolam group

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

    Drug: remimazolam sedation

Interventions

  • Drugremimazolam sedation

    remimazolam sedation

06

What researchers measure

Primary outcomes

  1. ED95

    ED95 of intravenous remimazolam for successful moderate sedation. ED95 will be estimated using isotonic regression based on the prespecified biased-coin up-and-down sequence. Sedation success is defined as MOAA/S≤3 within 10min after study-drug administration, without rescue sedative or clinically significant movement requiring additional medication. The 95% confidence interval will be calculated using bootstrap resampling.

    Time frame: within 10 minutes after the initial dose

07

Study locations

1 site
  • Sir run run shaw hospital
    Hangzhou, Zhejiang 310000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2025 to primary completion in Sep 2026, 15 months.

Of 347 non-industry interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's 15 months is below that.

Counting every sponsor, half of 425 studies reached it within 23 months; a quarter within 8 and three quarters within 46.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 27, 2026: primary completion Sep 2025 → Sep 2026 and completion Oct 2025 → Sep 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
May 14, 2025
First posted
May 31, 2025
StartActual
Jun 1, 2025
Primary completionActual
Sep 30, 2026was Sep 2025
CompletionActual
Sep 30, 2026was Oct 2025
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Completed
changed Oct 27, 2026
Sites
1 site added — first site in China
Show site
  • Sir run run shaw hospital · Hangzhou, China
Oct 27, 2026
Primary completion
Sep 30, 2025→Sep 30, 2026 (actual)
Oct 27, 2026
Study completion
Oct 31, 2025→Sep 30, 2026 (actual)
Oct 27, 2026
Enrollment
40 (estimated)→50 (actual)
Oct 27, 2026
Eligibility
1 inclusion criterion edited; 1 exclusion criterion edited
What changed in the criteria
Inclusion criteria
  • EditedAmerican Society of Anesthesiologists (ASA) classification < Grade IV.physical status I-III
Exclusion criteria
  • Editedvulnerable groups, including those with mental illness, cognitive impairment, critically ill patients, pregnant women, illiterates, etc.
Oct 27, 2026
Primary outcomes
1 time frame changed, 1 description edited
What changed in the outcomes
  • Time frameED951 day → within 10 minutes after the initial dose
  • DescriptionED95: how it is measured was reworded
Oct 27, 2026
Sponsor
Gang Chen→Sir Run Run Shaw Hospital
Oct 27, 2026
Design
Phase 4→Not applicable
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Not yet recruiting→Completed
    1 site added — first site in China
    Show site
    • Sir run run shaw hospital · Hangzhou, China
    Primary completion Sep 30, 2025→Sep 30, 2026 (now actual)
    Study completion Oct 31, 2025→Sep 30, 2026 (now actual)
    Enrollment 40 (estimated)→50 (actual)
    Eligibility 1 inclusion criterion edited; 1 exclusion criterion edited
    What changed in the criteria
    Inclusion criteria
    • EditedAmerican Society of Anesthesiologists (ASA) classification < Grade IV.physical status I-III
    Exclusion criteria
    • Editedvulnerable groups, including those with mental illness, cognitive impairment, critically ill patients, pregnant women, illiterates, etc.
    Primary outcomes 1 time frame changed, 1 description edited
    What changed in the outcomes
    • Time frameED951 day → within 10 minutes after the initial dose
    • DescriptionED95: how it is measured was reworded
    Sponsor Gang Chen→Sir Run Run Shaw Hospital
    Design Phase 4→Not applicable
    + 6 other changes: index terms, identifiers, verification date, conditions, contact details and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06998732
Responsible party
Gang Chen (chief physician, Sir Run Run Shaw Hospital) — Principal investigator
First posted
May 31, 2025
Start date
Jun 1, 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026
Last update
Oct 27, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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