RemimazolamNCT07674719
Remimazolam on the Incidence of Postoperative Acute Kidney Injury
A study testing Remimazolam (Byfavo) and propofol in people with Remimazolam and Propofol, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
We hypothesized that in patients undergoing elective hepatobiliary-pancreatic surgery, the group in which anesthesia is induced and maintained with remimazolam during surgery would maintain hemodynamic stability and reduce the incidence of postoperative acute kidney injury compared to propofol. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Remimazolam, Propofol, Acute Kidney Injury
- What is being tested?
- Remimazolam (Byfavo) and propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Jun 2026to 26 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 19 or older and under 85
- Patients scheduled to undergo elective hepatopancreatic surgery under general anesthesia
- American Society of Anesthesiologists (ASA) physical grade 1-3
- Those who voluntarily consented to a written informed consent form prior to participation in the study
Who cannot join
- Patients with hypersensitivity to other benzodiazepine drugs, including remimazolam, and to the components of this drug (e.g., patients with severe hypersensitivity to dextran 40)
- Patients with hypersensitivity to propofol
- Patients with underlying conditions: liver, neurological disorders, or acute narrow-angle glaucoma
- Patients with severe or acute respiratory failure
- Patients in shock or a coma
- Patients taking TCA antidepressants
- Patients with preoperative chronic kidney disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Insun Park, 823178777499, pis121@hanmail.net
About this study
Official title: The Effect of Intraoperative Remimazolam Administration on the Incidence of Postoperative Acute Kidney Injury After Hepatobiliary and Pancreatic Surgery : a Prospective Randomized Controlled Trial
We hypothesized that in patients undergoing elective hepatobiliary-pancreatic surgery, the group in which anesthesia is induced and maintained with remimazolam during surgery would maintain hemodynamic stability and reduce the incidence of postoperative acute kidney injury compared to propofol. The purpose is to provide practical evidence for perioperative management differentiated from other surgeries for hepatobiliary-pancreatic surgery patients for whom intraoperative fluid therapy is restricted.
- Conditions
- Remimazolam, Propofol, Acute Kidney Injury, Hemodynamic Stability, Hepatobiliary Surgery, Fluid Therapy
- Being tested
- Remimazolam (Byfavo), propofol
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam (Byfavo)Drug
TCI of remimazolam (0.3 - 1.5 mcg/ml)
propofolDrug
TCI of propofol (4.0 - 5.0 mg/mL)
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Experimental | Not described Receives: Drug: Remimazolam (Byfavo) |
| Propofol | Active comparator | Not described Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
serum creatinine
Measured: preop, postop day 0, 1, 3, 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start26 Jun 2026 (estimated)
- Primary completion26 Jun 2027 (estimated)
- Study completion26 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RemimazolamStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Park InSun, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674719
- Sponsor's protocol ID
- B-2509-996-004
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Remimazolam Administration on the Incidence of Postoperative Acute Kidney Injury After Hepatobiliary and Pancreatic Surgery : a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07674719
- Acronym / sponsor ID
- B-2509-996-004
- Conditions
- Remimazolam, Propofol, Acute Kidney Injury, Hemodynamic Stability, Hepatobiliary Surgery, Fluid Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 26 Jun 2026 (estimated)
- Primary completion
- 26 Jun 2027 (estimated)
- Study completion
- 26 Jun 2028 (estimated)
- First posted
- 29 Jun 2026 (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.
We hypothesized that in patients undergoing elective hepatobiliary-pancreatic surgery, the group in which anesthesia is induced and maintained with remimazolam during surgery would maintain hemodynamic stability and reduce the incidence of postoperative acute kidney injury compared to propofol. The purpose is to provide practical evidence for perioperative management differentiated from other surgeries for hepatobiliary-pancreatic surgery patients for whom intraoperative fluid therapy is restricted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Experimental | Drug: Remimazolam (Byfavo) |
| Propofol | Active comparator | Drug: propofol |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 19 or older and under 85
- Patients scheduled to undergo elective hepatopancreatic surgery under general anesthesia
- American Society of Anesthesiologists (ASA) physical grade 1-3
- Those who voluntarily consented to a written informed consent form prior to participation in the study
Key exclusion criteria (7 listed)
- Patients with hypersensitivity to other benzodiazepine drugs, including remimazolam, and to the components of this drug (e.g., patients with severe hypersensitivity to dextran 40)
- Patients with hypersensitivity to propofol
- Patients with underlying conditions: liver, neurological disorders, or acute narrow-angle glaucoma
- Patients with severe or acute respiratory failure
- Patients in shock or a coma
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 (Byfavo)TCI of remimazolam (0.3 - 1.5 mcg/ml) | Drug | Remimazolam |
| propofolTCI of propofol (4.0 - 5.0 mg/mL) | Drug | Propofol |
Primary outcome
Acute kidney injury
Time frame: preop, postop day 0, 1, 3, 5
serum creatinine
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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The Effect of Remimazolam Tosylate on the Incidence of Postoperative Delirium in Older Patients Undergoing Cardiac Surgery: A Prospective Randomized Controlled Trial
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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.
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 (Byfavo) and propofol in people with Remimazolam and Propofol, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 29 Jun 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Insun Park, MD, PhD (823178777499, pis121@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury (time frame: preop, postop day 0, 1, 3, 5). 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 29 Jun 2026.