A Phase 4 interventional study of Eleveld model-guided dosing and Standard weight-based label dosing in Remimazolam and Pharmacokinetics and Pharmacodynamics, sponsored by Seoul National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Other
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:
Exclusion Criteria:
Dosage calculated with Eleveld PK/PD model
Drug: Eleveld model-guided dosing
Loading with 9 mg/kg/h until loss of consciousness, then maintenance with 1-2 mg/kg/h
Drug: Standard weight-based label dosing
Eleveld PK/PD model-guided dosing via a web-based calculator
Induction at 9 mg/kg/h and maintenance at 1-2 mg/kg/h
Eye-Opening Time, EOT
Time frame: Time from the discontinuation of remimazolam to eye-opening upon verbal command (min), up to 1h
Time to loss of consciousness (LOC)
Time frame: Time from the start of remimazolam administration to loss of consciousness (min), up to 1h
Intraoperative Bispectral Index (BIS) values
Time frame: Perioperative/Periprocedural
Incidence of intraoperative bradycardia (heart rate < 45 bpm)
Time frame: Perioperative/Periprocedural
Incidence of intraoperative tachycardia (heart rate > 110)
Time frame: Perioperative/Periprocedural
Incidence of intraoperative hypotension (mean blood pressure < 65 mmHg)
Time frame: Perioperative/Periprocedural
Incidence of intraoperative hypertension (SBP > 140 mmHg)
Time frame: Perioperative/Periprocedural
Total dose of intraoperative remimazolam (mg)
Time frame: Perioperative/Periprocedural
Total dose of intraoperative remifentanil (㎍)
Time frame: Perioperative/Periprocedural
Total dose(s) of intraoperative vasopressor(s)
Ephedrine (mg)
Time frame: Perioperative/Periprocedural
Extubation time (min)
Time frame: Time from the discontinuation of remimazolam to the removal of the endotracheal tube, up to 1h
Incidence of flumazenil administration
Time frame: From discontinuation of remimazolam to patient discharge from the operating room, up to 1h
Incidence of rescue sevoflurane use
Time frame: Perioperative/Periprocedural
Incidence of oxygen supplementation in the Post-Anesthesia Care Unit (PACU)
Time frame: Perioperative/Periprocedural, on the day of surgery
Incidence of postoperative delirium
Time frame: Perioperative/Periprocedural, up to 1 week
Incidence of postoperative nausea and vomiting (PONV)
Time frame: Perioperative/Periprocedural, up to 1 week
Length of stay in the PACU (min)
Time frame: Perioperative/Periprocedural, on the day of surgery
Incidence of re-sedation
Drop in the Modified Observer's Assessment of Alertness/Sedation \[MOAA/S\] score to 3 or lower during the PACU stay
Time frame: Perioperative/Periprocedural, on the day of surgery
Incidence of intraoperative awareness
assessed using the Modified Brice Questionnaire
Time frame: Perioperative/Periprocedural
Total dose(s) of intraoperative vasopressor(s)
phenylephrine (㎍)
Time frame: Perioperative/Periprocedural
Total dose(s) of intraoperative vasopressor(s)
norepinephrine (㎍)
Time frame: Perioperative/Periprocedural
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Seoul National University Hospital