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Impact of CES1 Genotype on Remimazolam

NCT05841667 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2024-10-15

No results posted yet for this study

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.

Conditions

  • Adult
  • Middle Aged
  • Elective Surgical Procedures

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.

Sponsors & Collaborators

  • Korea University Guro Hospital

    lead OTHER

Principal Investigators

  • Byung Gun Lim, MD, PhD · Korea University Guro Hospital

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-06
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05841667 on ClinicalTrials.gov