Effect of CES1 Genotype on Remimazolam in Surgery
A Clinical Study to Explore the Effect of Carboxylesterase 1 (CES1) Genotype on Pharmacokinetics, Safety, and Efficacy of Remimazolam
This study is testing how a specific gene affects how well the drug remimazolam works and is processed in the body for patients having planned surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 19 Years to 70 Years |
| Sex | All |
| Sponsor | Korea University Guro Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05841667 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how the CES1 genotype influences the pharmacokinetics, safety, and efficacy of remimazolam in patients undergoing elective surgical procedures. By examining patients aged 19 to 70 with ASA physical status 1 or 2, the study aims to understand the genetic factors that may affect drug metabolism and response. The research focuses on patients who are not undergoing emergency surgeries and do not have significant comorbidities that could interfere with the study outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19-70 undergoing elective surgery with ASA physical status 1 or 2.
Not a fit: Patients with uncontrolled hypertension, diabetes, or those undergoing emergency procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized anesthesia care, improving safety and efficacy for patients undergoing elective surgeries.
How similar studies have performed: While the specific impact of CES1 genotype on remimazolam has not been extensively studied, similar pharmacogenomic approaches have shown promise in optimizing drug therapies in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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 disorders * Myasthenia gravis or myasthenia gravis syndrome * Newly diagnosed myocardial infarction/clinically significant coronary artery disease, cerebral ischemic attack/stroke within 6 months, or significant untreated coronary artery disease * Implanted rate-responsive cardiac pacemaker with a bioelectrical impedance sensor. * Intrinsic brain disorders or other conditions that make it difficult to determine the depth of anesthesia through EEG measurements (e.g., epilepsy) * History of severe allergies * Cognitive impairment that prevents comprehension of the instructions and consent form of this study, in case of sedation * Expected intraoperative blood loss of 1000 ml or more * Judged by the investigator to be unsuitable for participation in this study due to other reasons
Where this trial is running
Seoul
- Korea University Guro Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Byung Gun Lim, MD, PhD — Korea University Guro Hospital
- Study coordinator: Byung Gun Lim, MD, PhD
- Email: bglim9205@korea.ac.kr
- Phone: 82-2-2626-1437
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.