Response Surface Modeling of Remimazolam and Sevoflurane
Recruiting now · Not applicable
Conditions studied: Laparoscopic Surgery
In brief
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.
Key facts
- Study ID
- NCT07620782
- Run by
- Pusan National University Yangsan Hospital
- People needed
- 80
- Starts
- 2026-05-15
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-06-02
Who can join
Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Pusan National University Yangsan Hospital — Yangsan, South Korea (enrolling)
Full record on ClinicalTrials.gov
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