About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 19 to 79 years undergoing elective non-cardiac surgery expected to last 60 minutes or longer under general anesthesia with endotracheal intubation
Disqualifiers
Emergency surgery
Surgery requiring evoked potential (EP) monitoring
Chronic benzodiazepine users
Body Mass Index (BMI) ≥ 35 kg/㎡
Trial design
Parallel
Treatments tested in this trial
Eleveld model-guided dosing
DrugEleveld PK/PD model-guided dosing via a web-based calculator
Standard weight-based label dosing
DrugInduction at 9 mg/kg/h and maintenance at 1-2 mg/kg/h
Treatment groups
Trial outcomes
Primary outcomes
Eye-Opening Time, EOT
Secondary outcomes
Time to loss of consciousness (LOC)
Intraoperative Bispectral Index (BIS) values
Incidence of intraoperative bradycardia (heart rate < 45 bpm)
Incidence of intraoperative tachycardia (heart rate > 110)
Sponsors and contacts
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Seoul National University Hospital
Lead sponsor
Hana Pharm Co., Ltd.
Collaborator