Studying How Remimazolam and Sevoflurane Work Together During Anesthesia Comparing Two Models to Understand Their Interaction

What this Trial Is About

Researchers are investigating how remimazolam, a new ultra-short-acting benzodiazepine anesthetic, interacts with sevoflurane, a commonly used volatile anesthetic, during general anesthesia. The study focuses on adult patients undergoing elective laparoscopic surgery and aims to understand if the combination of these drugs produces a synergistic, additive, or less than additive effect. This is important because remimazolam offers stable hemodynamics but may have unpredictable hypnotic effects compared to traditional sedation monitors like the bispectral index BIS. Participants will receive various combinations of remimazolam infusion rates 0 to 6 mgkgh and sevoflurane inhalation concentrations 0 to 2 vol% during anesthesia induction. The study uses response surface modeling with two interaction models, the Minto and Greco models, to analyze pharmacodynamic interactions. Data collected includes BIS values and predicted drug concentrations, analyzed by specialized software. During the study, patients will undergo standard anesthetic induction with monitoring of consciousness levels and vital signs such as heart rate and blood pressure throughout surgery. Researchers will assess outcomes like interaction coefficients between the drugs, BIS responses, loss and recovery of consciousness, and intraoperative cardiovascular measures. The study is open-label, and participation involves careful monitoring during surgery to evaluate how the anesthetics work together.

Response Surface Modeling of Remimazolam and Sevoflurane