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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Pusan National University Yangsan Hospital
RECRUITING
Yangsan
Contact Information
Primary
Hee Young Kim, MD, PhD
anekhy@gmail.com
82-55-360-2129
Time Frame
Start Date: 2026-05-15
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 80
Treatments
Experimental: Remimazolam and Sevoflurane Combination During Anesthetic Induction
Participants undergoing elective surgery under general anesthesia will receive varying combinations of remimazolam and sevoflurane during anesthetic induction to evaluate pharmacodynamic interactions using response surface modeling.
Related Therapeutic Areas
Sponsors
Leads: Pusan National University Yangsan Hospital

This content was sourced from clinicaltrials.gov