Remimazolam on the Incidence of Postoperative Acute Kidney Injury

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-85
SponsorSeoul National University Bundang Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remimazolam (Byfavo)

    Drug

    TCI of remimazolam (0.3 - 1.5 mcg/ml)

  • propofol

    Drug

    TCI of propofol (4.0 - 5.0 mg/mL)

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: RemimazolamExperimental treatment 1 intervention
Group B: PropofolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Acute kidney injury

serum creatinine

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: