Chronic Kidney FailureBCDNCT06998732
BCD to Measure the ED95 of Remimazolam-Assisted Sedation in Arteriovenous Fistula Creation Surgery
A study testing remimazolam sedation in people with Chronic Kidney Failure, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
This study intends to measure the ED95 of remimazolam-assisted sedation in arteriovenous fistula creation by BCD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Failure
- What is being tested?
- remimazolam sedation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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) physical status I-III
- BMI range: 18-28kg/m2 (including borderline values).
Who cannot join
- 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, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Biased Coin Design (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.
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.
- Conditions
- Chronic Kidney Failure
- Being tested
- remimazolam sedation
- Keywords
- Biased Coin Design, uremia, remimazolam, ED95
- Medical subject headings
- Kidney Failure, Chronic, Uremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remimazolam sedationDrug
remimazolam sedation
| Study group | Role | What they receive |
|---|---|---|
| remimazolam group | Experimental | Measurement of ED95 in uremic patients sedated with remimazolam using the BCD method Receives: Drug: remimazolam sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 10 minutes after the initial dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Jun 2025
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney FailureStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Chen, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998732
- Sponsor's protocol ID
- remimazolam
- Other IDs
- 13152
- Acronym
- BCD
- Status last verified
- Oct 2026
- First submitted
- 14 May 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Biased Coin Design (BCD) to Measure the ED95 of Remimazolam-Assisted Sedation in Arteriovenous Fistula Creation Surgery
- ClinicalTrials.gov ID
- NCT06998732
- Acronym / sponsor ID
- BCD / remimazolam
- Conditions
- Chronic Kidney Failure
- Keywords
- Biased Coin Design, uremia, remimazolam, ED95
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| remimazolam group | Experimental | Drug: remimazolam sedationMeasurement of ED95 in uremic patients sedated with remimazolam using the BCD method |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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) physical status I-III
- BMI range: 18-28kg/m2 (including borderline values).
Key exclusion criteria (4 listed)
- 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, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remimazolam sedationremimazolam sedation | Drug | remimazolam group |
Primary outcome
ED95
Time frame: within 10 minutes after the initial dose
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remimazolam sedation in people with Chronic Kidney Failure, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED95 (time frame: within 10 minutes after the initial dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.