Actively Recruiting
Impact of CES1 Genotype on Remimazolam
Led by Korea University Guro Hospital · Updated on 2024-10-15
120
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Impact of CES1 Genotype on Remimazolam
Who Can Participate
Eligibility Criteria
You may qualify if you...
- American Society of Anesthesiologists (ASA) physical status 1 or 2
- Age 19-70 years
- Scheduled for elective surgery
You will not qualify if you...
- Concomitant regional anesthesia
- Uncontrolled hypertension (systolic blood pressure >180 mmHg)
- Uncontrolled diabetes mellitus (HbA1c >9.0%)
- Aspartate transaminase (AST), Alanine transferase (ALT), or Total bilirubin levels more than twice the normal upper limit
- Estimated glomerular filtration rate below 60 ml/min/1.73m2
- Moderate to severe chronic pulmonary obstructive 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 if tolerance is present
- History of anxiety, alcohol or drug dependence, or addiction to tricyclic antidepressants
- Known hypersensitivity or adverse reactions to benzodiazepines, flumazenil, or other anesthesia agents
- Lactose-related genetic disorders
- Myasthenia gravis or related syndromes
- Recent myocardial infarction, significant coronary artery disease, stroke, or untreated coronary artery disease within 6 months
- Implanted rate-responsive cardiac pacemaker with bioelectrical impedance sensor
- Brain disorders that hinder EEG anesthesia depth monitoring (e.g., epilepsy)
- History of severe allergies
- Cognitive impairment preventing understanding of study instructions and consent
- Expected blood loss of 1000 ml or more during surgery
- Any other reasons deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
H
Hye Bin Kim, MD, PhD
CONTACT
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here