Remimazolam on the Incidence of Postoperative Acute Kidney Injury

NCT07674719 | Not Yet Recruiting

• 1 other identifier: B-2509-996-004
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Acute kidney injury

  serum creatinine

  preop, postop day 0, 1, 3, 5

Study Arms (2)

Remimazolam

EXPERIMENTAL

Drug: Remimazolam (Byfavo)

Propofol

ACTIVE COMPARATOR

Drug: propofol

Interventions

Remimazolam (Byfavo) DRUG

TCI of remimazolam (0.3 - 1.5 mcg/ml)

Remimazolam

propofol DRUG

TCI of propofol (4.0 - 5.0 mg/mL)

Propofol

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

remimazolam; Propofol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Insun Park, MD, PhD

CONTACT

823178777499; pis121@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 29, 2026
• Study Start: June 26, 2026
• Primary Completion (Estimated): June 26, 2027
• Study Completion (Estimated): June 26, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)