RecruitingNCT05841667

Impact of CES1 Genotype on Remimazolam

A Clinical Study to Explore the Effect of Carboxylesterase 1 (CES1) Genotype on Pharmacokinetics, Safety, and Efficacy of Remimazolam


Sponsor

Korea University Guro Hospital

Enrollment

120 participants

Start Date

Sep 6, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Remimazolam is primarily metabolized via CES1, and other drugs that are commonly metabolized by CES1 are known to have their pharmacokinetics and clinical effects affected by genetic polymorphisms in CES1. The goal of this observational study is to investigate the impact of the CES1 genotype on the pharmacokinetics, safety, and efficacy of remimazolam in patients undergoing elective surgery.


Eligibility

Min Age: 19 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

Remimazolam is a newer sedative/anesthetic drug used during surgery. Like many drugs, it is broken down in the body by specific enzymes — in this case, an enzyme called CES1 (carboxylesterase 1). The gene controlling CES1 varies between individuals, meaning some people metabolize remimazolam faster or slower than others, which could affect how deeply they are sedated and how quickly they wake up. This study investigates whether CES1 genetic variation (genotype) affects how remimazolam behaves during anesthesia. Participants are adults aged 19 to 70 who are scheduled for elective (non-emergency) surgery under general anesthesia. People with serious liver, kidney, lung, or heart conditions, those with uncontrolled diabetes, or those taking benzodiazepine medications are excluded. Understanding how genetics affect drug metabolism is the foundation of precision medicine — the idea that treatments can be tailored to individuals based on their genetic makeup. If CES1 genotype significantly influences remimazolam metabolism, anesthesiologists could potentially use a patient's genetic profile to choose the right dose, resulting in safer, more predictable anesthesia.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRemimazolam besylate

This is an observational study, meaning that no interventions are actually administered to the participants. However, blood and urine samples will be collected for research purposes. Participants will receive remimazolam besylate for at least 2 hours during anesthesia and surgery. Blood will be drawn to determine the concentration of remimazolam in the blood at the following time points: (1) before remimazolam administration, (2) after remimazolam administration has lasted at least 2 hours without a change in concentration, (3) immediately before discontinuation of remimazolam if there has been a change in concentration since the second blood draw, (4) within 5 minutes of discontinuation, (5) within 15-60 minutes of discontinuation, and (6) 90 minutes after discontinuation. Urine will also be collected after the end of anesthesia to check for metabolites of remimazolam.


Locations(1)

Korea University Guro Hospital

Seoul, South Korea

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NCT05841667


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