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Recruiting NCT05841667

Impact of CES1 Genotype on Remimazolam

Trial Parameters

Condition Adult
Sponsor Korea University Guro Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 120
Sex ALL
Min Age 19 Years
Max Age 70 Years
Start Date 2023-09-06
Completion 2025-12-31
Interventions
Remimazolam besylate

Brief 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 Criteria

Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status 1 or 2 * Age 19-70 years * Elective surgery Exclusion Criteria: * Concomitant regional anesthesia * Uncontrolled hypertension (systolic blood pressure \>180 mmHg) * Uncontrolled diabetes mellitus (HbA1c \>9.0%) * Aspartate transaminase (AST), Alanine transferase (ALT), Total bilirubin \> more than 2 times the normal upper limit * Estimated glomerular filtration rate \<60 ml/min/1.73m2 * Moderate to severe chronic pulmonary obstructive disease or respiratory failure * Emergency * Hepatectomy, Liver transplantation * Cardiopulmonary bypass use * Craniotomy due to head trauma, unstable intracranial pressure, or brain disease * Use of benzodiazepine medications (if tolerance is present) * Anxiety, alcohol/drug dependence, or addiction to tricyclic antidepressants * Reported hypersensitivity and adverse reactions to benzodiazepines, flumazenil, and other agents used during anesthesia * Lactose-related genetic

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