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NCT Number: NCT07674719

Remimazolam on the Incidence of Postoperative Acute Kidney Injury

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.

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Key information

Conditions

Remimazolam Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fluid Therapy Fluid Therapy DURING SURGERY Hemodynamic Stability Hepatobiliary Surgery Kidney Diseases Male Urogenital Diseases Propofol Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

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

Location contact

Insun Park

CONTACT

[email protected]

823178777499

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam (Byfavo)

Drug

TCI of remimazolam (0.3 - 1.5 mcg/ml)

Propofol

Drug

TCI of propofol (4.0 - 5.0 mg/mL)

Primary outcomes

  1. Acute kidney injury

    Time frame: preop, postop day 0, 1, 3, 5

    serum creatinine

Study contacts

Contact information is provided by the study sponsor or research team.

Insun Park, MD, PhD

CONTACT

[email protected]

823178777499

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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