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RECRUITING
NCT07620782
NA

Response Surface Modeling of Remimazolam and Sevoflurane

Sponsor: Pusan National University Yangsan Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

20 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-05-15

Completion Date

2027-12-31

Last Updated

2026-06-02

Healthy Volunteers

No

Interventions

DRUG

Remimazolam (Byfavo)

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

DRUG

Sevoflurane (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