Remimazolam on the Incidence of Postoperative Acute Kidney Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remimazolam (Byfavo), propofol.
- Who it may be relevant to
- Registry conditions: Remimazolam, Propofol, Acute Kidney Injury, Hemodynamic Stability. Basic parameters: 19 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Remimazolam (Byfavo)
TCI of remimazolam (0.3 - 1.5 mcg/ml) - Drug propofol
TCI of propofol (4.0 - 5.0 mg/mL)
Primary outcome measures
- Acute kidney injury [Time frame: preop, postop day 0, 1, 3, 5]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
South Korea · 1 center
- Seoul National University Bundang Hospital — Seongnam-si
Identifiers
NCT: NCT07674719 · B-2509-996-004