Response Surface Modeling of Remimazolam and Sevoflurane
Response Surface Model Between Remimazolam and Sevoflurane; Comparison of the Minto and the Greco Model
Pusan National University Yangsan Hospital
80 participants
May 15, 2026
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
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
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Interventions
Remimazolam will be administered at infusion rates ranging from 0 to 6 mg/kg/h using an infusion pump with pharmacokinetic simulation software.
Sevoflurane will be administered by inhalation with targeted end-tidal concentrations between 0 and 2 vol%.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07620782