Remimazolam on the Incidence of Postoperative Acute Kidney Injury

The Effect of Intraoperative Remimazolam Administration on the Incidence of Postoperative Acute Kidney Injury After Hepatobiliary and Pancreatic Surgery : a Prospective Randomized Controlled Trial

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07674719

Enrollment

Registered

2026-06-29

Start date

2026-06-26

Completion date

2028-06-26

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Fluid Therapy, Fluid Therapy DURING SURGERY, Hemodynamic Stability, Hepatobiliary Surgery, Propofol, Remimazolam

Brief 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. 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

DRUGRemimazolam (Byfavo)

TCI of remimazolam (0.3 - 1.5 mcg/ml)

DRUGpropofol

TCI of propofol (4.0 - 5.0 mg/mL)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Acute kidney injury	preop, postop day 0, 1, 3, 5	serum creatinine

Countries

South Korea

Contacts

CONTACTInsun Park, MD, PhD

pis121@hanmail.net823178777499

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026