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NCT07675850
Efficacy and Safety of Eleveld PK/PD Model-based Dosing During General Anesthesia
Conditions: Remimazolam, Pharmacokinetics and Pharmacodynamics
Sex: All
Ages: 19 Years – 79 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 68
Sponsor: Seoul National University Hospital
Location: Seoul National University Hospital Seoul Jongno-gu
Summary
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
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
Source: ClinicalTrials.gov (NCT07675850). StuddyBuddy aggregates publicly available trial information.