Impact of CES1 Genotype on Remimazolam
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-70
SponsorKorea University Guro Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
American Society of Anesthesiologists (ASA) physical status 1 or 2
Age 19-70 years
Elective surgery
Disqualifiers
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
Trial population
The study will be conducted on adult patients aged 19-70 years, ASA physical status 1-2, undergoing elective surgery in the operating room of Korea University Guro Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Remimazolam besylate
DrugThis 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.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: CES1 without or without single nucleotide polymorphism (SNP)1 intervention
Trial outcomes
Primary outcomes
1
Dose-adjusted steady-state concentration of remimazolam
Determine the dose-adjusted steady-state concentration of remimazolam using Liquid Chromatography-Mass Spectrometry/Mass Spectrometry (LC-MS/MS)
Time frame
Immediately before the initiation of remimazolam administration ~ 120 minutes after the cessation of remimazolam2
Maintenance dose of remimazolam for maintaining general anesthesia
Hourly maintenance dose of remimazolam for maintaining general anesthesia
Time frame
Immediately before the initiation of remimazolam administration ~ 120 minutes after the cessation of remimazolam3
Total dose of remimazolam used to induce general anesthesia
Determine the total dose of remimazolam to achieve loss of consciousness (LOC). Modified Observer's Alertness/Sedation Scale (MOAA/S) \<2 indicates LOC. The MOAA/S scale assesses a patient's level of alertness and response to stimulation, and is scored on a 6-point scale (6: awake and alert, 1: deeply asleep and unresponsive to any stimulus).
Time frame
Initiation of remimazolam administration ~ 5 minutes after start of remimazolamSecondary outcomes
1
Time to LOC after remimazolam administration during anesthesia induction
Determine the time to achieve LOC after remimazolam dosing.
Time frame
Initiation of remimazolam administration ~ 5 minutes after start of remimazolam2
Time to bispectral index(BIS) < 60 after remimazolam administration during anesthesia induction
Determine the time to achieve BIS \<60 after remimazolam dosing
Time frame
Initiation of remimazolam administration ~ 10 minutes after start of remimazolam3
Changes in BIS during induction and maintenance of anesthesia
Measure BIS during anesthesia
Time frame
Initiation of remimazolam administration ~ 30 minutes after cessation of remimazolam4
Percentage maintained BIS >60 during general anesthesia
Calculate "Time maintained BIS \>60 / Time remimazolam administered"
Time frame
Initiation of remimazolam administration ~ Cessation of remimazolam(up to 10 hours after start of remimazolam administration)Sponsors and contacts
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Source ClinicalTrials.gov