Response Surface Modeling of Remimazolam and Sevoflurane

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorPusan National University Yangsan Hospital

About this trial

This prospective randomized open-label study aims to investigate the pharmacodynamic interaction between remimazolam and sevoflurane during general anesthesia using response surface modeling. Although remimazolam has favorable hemodynamic stability compared with propofol, its hypnotic effect may be less predictable and poorly correlated with conventional sedation monitoring indices such as the bispectral index (BIS). In clinical practice, remimazolam and sevoflurane are often combined during induction and maintenance of anesthesia; however, the optimal interaction between these agents remains unclear.

This study will evaluate whether the interaction between remimazolam and sevoflurane is synergistic, additive, or infra-additive using two representative response surface interaction models: the Minto model and the Greco model. BIS values and predicted effect-site concentrations will be analyzed using NONMEM software.

Eligibility criteria

Qualifiers

Adults aged 20 to 80 years

Scheduled for elective surgery under general anesthesia at Pusan National University Yangsan Hospital

American Society of Anesthesiologists (ASA) physical status I or II

Able to provide written informed consent

Disqualifiers

Known allergy to remimazolam or sevoflurane

Renal, hepatic, neuromuscular, or neurological disease

Use of medications affecting the central nervous system

Chronic psychoactive drug use

Trial design

Treatments tested in this trial

  • Remimazolam (Byfavo)
  • Sevoflurane (Volatile Anesthetic)

Treatment groups

80 Participants
are divided into 1 treatment group