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โ† Trials
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Efficacy and Safety of Eleveld PK/PD Model-based Dosing During General Anesthesia

RecruitingPhase 4Ages 19 Years - 79 YearsAllSeoul National University Hospital
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In plain words

What the trial is, and whether it could suit you

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 eff

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๐Ÿ“‹ Eligibility rules (as published)
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) โ‰ฅ 35 kg/ใŽก * Chronic kidney disease * Hepatic dysfunction or chronic liver disease * Contraindication or history of hypersensitivity to remimazolam * American Society of Anesthesiologists (ASA) physical status โ‰ฅ IV * Pregnant women * Contraindication or history of hypersensitivity to flumazenil
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What it tests

  • Eleveld model-guided dosing
  • Standard weight-based label dosing
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Where

1 site
Seoul National University Hospital
Seoul, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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