Actively Recruiting
Effect of Carboxylesterase 1 (CES1) Genotype on Pharmacokinetics, Safety, and Efficacy of Remimazolam in Elective Surgery
Led by Korea University Guro Hospital · Updated on 2024-10-15
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how genetic differences in the enzyme Carboxylesterase 1 (CES1) affect the way remimazolam, a drug used during general anesthesia, is processed in the body. This observational study focuses on adults aged 19 to 70 who are undergoing elective surgery. The goal is to understand the impact of CES1 gene variations on remimazolam's safety, effectiveness, and how the drug moves through the body. Participants will undergo testing to determine their CES1 genotype through a laboratory blood test, which identifies different types of genetic variations called single nucleotide polymorphisms (SNPs). During surgery, participants will receive remimazolam besylate as part of their anesthesia for at least two hours. Blood samples will be collected at multiple time points before, during, and after remimazolam administration to measure drug concentrations. Urine samples will also be collected after anesthesia to analyze drug metabolites. Throughout the study, researchers will measure various outcomes including the dose of remimazolam needed to maintain anesthesia, changes in brain activity monitored by bispectral index (BIS), recovery times, pain levels, and any adverse events up to 48 hours after surgery. Additional outcomes include surgery duration, anesthesia time, and length of hospital stay. The study involves detailed monitoring and assessments related to anesthesia safety and effectiveness, with data collection continuing up to one month post-surgery.
CONDITIONS
Brief Title
Impact of CES1 Genotype on Remimazolam
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 to 70 years
- American Society of Anesthesiologists (ASA) physical status 1 or 2
- Scheduled for elective surgery
You will not qualify if you...
- Receiving concomitant regional anesthesia
- Uncontrolled hypertension with systolic blood pressure over 180 mmHg
- Uncontrolled diabetes mellitus with HbA1c above 9.0%
- Liver function tests (AST, ALT, Total bilirubin) more than twice the normal upper limit
- Estimated glomerular filtration rate below 60 ml/min/1.73m2
- Moderate to severe chronic obstructive pulmonary disease or respiratory failure
- Emergency surgery
- Hepatectomy or liver transplantation
- Use of cardiopulmonary bypass
- Craniotomy due to head trauma, unstable intracranial pressure, or brain disease
- Use of benzodiazepine medications with tolerance
- Anxiety, alcohol/drug dependence, or addiction to tricyclic antidepressants
- Hypersensitivity or adverse reactions to benzodiazepines, flumazenil, or anesthesia agents
- Lactose-related genetic disorders
- Myasthenia gravis or myasthenia gravis syndrome
- Recent myocardial infarction, significant coronary artery disease, stroke within 6 months
- Implanted rate-responsive cardiac pacemaker with bioelectrical impedance sensor
- Intrinsic brain disorders preventing EEG depth of anesthesia measurement
- History of severe allergies
- Cognitive impairment preventing understanding of consent
- Expected intraoperative blood loss of 1000 ml or more
- Investigator judgment of unsuitability for participation due to other reasons
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 hours during surgery and anesthesia
Participants receive remimazolam besylate during elective surgery and anesthesia, and blood and urine samples are collected to assess drug concentration and metabolites.
Blood samples collected at multiple time points before, during, and after remimazolam administration; urine collected after anesthesia
Duration - Up to 1 month after surgery
Participants are observed for safety outcomes and recovery after surgery, including adverse events and hospital stay.
Follow-up visits or assessments during hospital stay and up to 1 month after surgery
Trial Site Locations
Total: 1 location
1
Korea University Guro Hospital
Seoul, South Korea, 08308
Actively Recruiting
Research Team
B
Byung Gun Lim, MD, PhD
H
Hye Bin Kim, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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