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Response Surface Modeling of Remimazolam and Sevoflurane

NCT07620782 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-06-02

No results posted yet for this study

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.

Conditions

  • Laparoscopic Surgery

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%.

Sponsors & Collaborators

  • Pusan National University Yangsan Hospital

    lead OTHER

Principal Investigators

  • Hee Young Kim, MD, PhD · Pusan National University Yangsan Hospital, Yangsan, South Korea

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2027-04-01
Completion
2027-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07620782 on ClinicalTrials.gov