Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2023-09-06
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CES1 without or without single nucleotide polymorphism (SNP)
We will determine the CES1 genotype of participants through a laboratory test. Several different types of SNPs can be identified, and analyses can be further stratified by CES1 SNP type.
Remimazolam besylate
This is an observational study, meaning that no interventions are actually administered to the participants. However, blood and urine samples will be collected for research purposes.
Participants will receive remimazolam besylate for at least 2 hours during anesthesia and surgery. Blood will be drawn to determine the concentration of remimazolam in the blood at the following time points: (1) before remimazolam administration, (2) after remimazolam administration has lasted at least 2 hours without a change in concentration, (3) immediately before discontinuation of remimazolam if there has been a change in concentration since the second blood draw, (4) within 5 minutes of discontinuation, (5) within 15-60 minutes of discontinuation, and (6) 90 minutes after discontinuation. Urine will also be collected after the end of anesthesia to check for metabolites of remimazolam.
Interventions
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Remimazolam besylate
This is an observational study, meaning that no interventions are actually administered to the participants. However, blood and urine samples will be collected for research purposes.
Participants will receive remimazolam besylate for at least 2 hours during anesthesia and surgery. Blood will be drawn to determine the concentration of remimazolam in the blood at the following time points: (1) before remimazolam administration, (2) after remimazolam administration has lasted at least 2 hours without a change in concentration, (3) immediately before discontinuation of remimazolam if there has been a change in concentration since the second blood draw, (4) within 5 minutes of discontinuation, (5) within 15-60 minutes of discontinuation, and (6) 90 minutes after discontinuation. Urine will also be collected after the end of anesthesia to check for metabolites of remimazolam.
Eligibility Criteria
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Inclusion Criteria
* Age 19-70 years
* Elective surgery
Exclusion Criteria
* 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
19 Years
70 Years
ALL
No
Sponsors
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Korea University Guro Hospital
OTHER
Responsible Party
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Byung Gun Lim
Professor
Principal Investigators
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Byung Gun Lim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Korea University Guro Hospital
Locations
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Korea University Guro Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023GR0069
Identifier Type: -
Identifier Source: org_study_id
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