Impact of CES1 Genotype on Remimazolam
Recruiting now
Conditions studied: Adult, Middle Aged, Elective Surgical Procedures
In brief
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.
Key facts
- Study ID
- NCT05841667
- Run by
- Korea University Guro Hospital
- People needed
- 120
- Starts
- 2023-09-06
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2024-10-15
Who can join
Age: 19 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- American Society of Anesthesiologists (ASA) physical status 1 or 2
- Age 19-70 years
- Elective surgery
You may not qualify if…
- 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 it is running
- Korea University Guro Hospital — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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