Efficacy and Safety of Eleveld PK/PD Model-based Dosing During General Anesthesia

Comparison of Efficacy and Safety Between Eleveld PK/PD Model-based Dosing and Standard Dosing During General Anesthesia

The goal of this randomized, controlled clinical trial is to evaluate the efficacy, safety, and recovery profile of an individualized, Eleveld pharmacokinetic/pharmacodynamic model-guided dosing strategy for remimazolam in adult patients undergoing elective non-cardiac surgery under general anesthesia.

The main questions it aims to answer are:

Does Eleveld model-guided customized dosing significantly reduce the eye-opening time at the end of surgery compared to standard weight-based dosing?

Can the Eleveld model-guided approach prevent relative drug accumulation and delayed emergence while maintaining an adequate depth of anesthesia and comparable hemodynamic stability?

Researchers will compare the Experimental Group (Eleveld model-guided dosing) to the Control Group (Standard weight-based label dosing) to see if preemptive dose optimization based on individual patient covariates effectively reduces the total drug consumption, frequency of rescue flumazenil administration, and emergence time.

Participants will:

• Be randomly assigned to receive remimazolam for the induction and maintenance of general anesthesia according to either the Eleveld model-guided customized regimen or the standard weight-based regimen.
• Have their depth of anesthesia continuously monitored using a Bispectral Index (BIS) sensor.
• Be assessed for the primary outcome (time to eye-opening upon verbal command after discontinuation of anesthetics) and secondary outcomes, including total drug consumption, hemodynamic stability, and postoperative complications (e.g., re-sedation, delirium, PONV).

Inclusion Criteria:

• Patients aged 19 to 79 years undergoing elective non-cardiac surgery expected to last 60 minutes or longer under general anesthesia with endotracheal intubation

Exclusion Criteria:

• Emergency surgery
• Surgery requiring evoked potential (EP) monitoring
• Chronic benzodiazepine users
• Body Mass Index (BMI) ≥ 35 kg/㎡
• Chronic kidney disease
• Hepatic dysfunction or chronic liver disease
• Contraindication or history of hypersensitivity to remimazolam
• American Society of Anesthesiologists (ASA) physical status ≥ IV
• Pregnant women
• Contraindication or history of hypersensitivity to flumazenil