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Remimazolam on the Incidence of Postoperative Acute Kidney Injury

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Seoul National University

Status

Not yet enrolling

Conditions

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

Treatments

Drug: Remimazolam (Byfavo)
Drug: propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT07674719
B-2509-996-004

Details and patient eligibility

About

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.

Enrollment

78 estimated patients

Sex

All

Ages

19 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

78 participants in 2 patient groups

Remimazolam
Experimental group
Treatment:
Drug: Remimazolam (Byfavo)
Propofol
Active Comparator group
Treatment:
Drug: propofol

Trial contacts and locations

1

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Central trial contact

Insun Park, MD, PhD

Data sourced from clinicaltrials.gov

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