RecruitingNot ApplicableNCT07620782

Response Surface Modeling of Remimazolam and Sevoflurane

Response Surface Model Between Remimazolam and Sevoflurane; Comparison of the Minto and the Greco Model


Sponsor

Pusan National University Yangsan Hospital

Enrollment

80 participants

Start Date

May 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 20 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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

Exclusion Criteria6

  • Known allergy to remimazolam or sevoflurane
  • Renal, hepatic, neuromuscular, or neurological disease
  • Use of medications affecting the central nervous system
  • Chronic psychoactive drug use
  • Ischemic heart disease
  • Pregnant women

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRemimazolam (Byfavo)

Remimazolam will be administered at infusion rates ranging from 0 to 6 mg/kg/h using an infusion pump with pharmacokinetic simulation software.

DRUGSevoflurane (Volatile Anesthetic)

Sevoflurane will be administered by inhalation with targeted end-tidal concentrations between 0 and 2 vol%.


Locations(1)

Pusan National University Yangsan Hospital

Yangsan, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07620782


Related Trials