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RECRUITING
NCT05841667

Impact of CES1 Genotype on Remimazolam

Sponsor: Korea University Guro Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

19 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2023-09-06

Completion Date

2025-12-31

Last Updated

2024-10-15

Healthy Volunteers

No

Interventions

DRUG

Remimazolam 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