Study to Test Accuracy of Cipepofol Target-Controlled Infusion During General Anesthesia in Elective Surgery Patients

What this Trial Is About

Researchers are conducting a multi-center, randomized, open-label clinical study to evaluate and improve the accuracy of the target-controlled infusion TCI model for cipepofol during general anesthesia in patients undergoing elective surgery. The study aims to verify and optimize the infusion parameters to ensure precise control of drug delivery in this setting. Participants will be randomly assigned to one of two groups receiving different plasma target-controlled concentrations of cipepofol during anesthesia induction a low concentration group 0.9 bcgml and a high concentration group 1.2 bcgml. An interim analysis will be done after collecting about 5% of data from each group to evaluate key parameters like the effect-site equilibrium rate constant Ke0. During the study, participants will undergo general anesthesia with tracheal intubation for elective surgeries lasting at least one hour. Researchers will monitor vital signs, anesthesia effects, and infusion accuracy, focusing on optimizing parameters such as CeLoCCeRoC and Ke0 within two hours. The study will include screening for eligibility, informed consent, and close observation throughout surgery with ongoing assessments to ensure safety and data quality.

A Study to Evaluate the Accuracy of aTCI Model of Cipepofol in Patients With General Anesthesia During Elective Surgery