Biological RhythmDrug Metabolism and Pharmacokinetics
Study summary
The purpose of this study was to observe and compare the differences in plasma concentration, dosage and carboxylesterase 1 activity of remimazolam when remimazolam is used for general anesthesia induction and maintenance at different times of the day, and to explore the effect of time rhythm on the pharmacokinetics and pharmacodynamics of remimazolam, so as to provide new ideas and clinical basis for optimizing medication regimens and anesthesia management.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
Inclusion Criteria:
Experiment 1: Measurement Experiment of Remimazolam Blood Concentration and Dosage
1. Age 18-65 years old, ASAI-II class, BMI18.5-25kg/m\^2;
2. Inpatients undergoing laparoscopic cholecystectomy;
3. The estimated time of operation is 1.5\~2.5 hours;
4. Voluntary participation and signed informed consent.
Experiment 2: Remimazolam metabolic enzyme CES1 activity measurement experiment
1. Age 18-75 years old, ASAI-III class;
2. Inpatients undergoing laparoscopic partial hepatic resection;
3. Voluntary participation and signed informed consent.
Exclusion Criteria:
Experiment 1:Measurement Experiment of Remimazolam Blood Concentration and Dosage
1. Pregnant or lactating women;
2. Patients who are allergic to remazolam or contraindicated;
3. Patients who are dependent on or tolerant to opioids or have long-term alcoholism;
4. Serious cardiovascular system, respiratory system, liver and kidney diseases;
5. History of obstructive sleep apnea;
6. Mental disorders or neurological diseases;
7. Patients who participated in clinical trials of other drugs within the last 3 months;
8. The attending physician or researcher considers that there are other circumstances that are not suitable for participation in this study;
9. Refuse to participate in the study
Experiment 2: Remimazolam metabolic enzyme CES1 activity measurement experiment
1. Pregnant or lactating women;
2. Patients who are allergic to remazolam or contraindicated;
3. Patients who are dependent on or tolerant to opioids or have long-term alcoholism;
4. Serious cardiovascular system, respiratory system;
5. History of obstructive sleep apnea;
6. Mental disorders or neurological diseases;
7. Patients who participated in clinical trials of other drugs within the last 3 months;
8. The attending physician or researcher considers that there are other circumstances that are not suitable for participation in this study;
9. Refuse to participate in the study
Primary outcome measure(s)
Remimazolam dosage — During the operation During the maintenance of anesthesia, adjust the infusion rate of remimazolam to maintain the BIS value at 40-60, and record the dosage of remimazolam
Remimazolam blood concentration — Within two weeks after the operation Arterial blood of 2 ml was collected immediately after the end of remimazolam infusion during the anesthesia induction period and 6 minutes after the end of infusion, respectively. After each sample collection, rinse the ductus arteriosus with 1 ml of normal saline. The blood sample was drawn into a plastic tube containing ethylenediaminetetraacetic acid and stored at 4℃. Centrifuge the blood sample within 10 minutes after collection. Transfer the supernatant plasma into a polypropylene tube within 15 minutes after separation and store it immediately at -20℃. Blood samples should be stored at -80℃ within 4 hours after collection. The blood concentration of remimazolam and the concentration of its metabolite CNS7054 were determined by ultra-performance liquid chromatography-tandem mass spectrometry within two weeks after blood collection.
CES1 activity — Within two weeks after the operation When a surgeon removes a liver tumor, 50 mg of normal liver tissue adjacent to the tumor is quickly taken. The liver tissue is rinsed with normal saline, dried with filter paper, and placed in a cryotube. It is then rapidly frozen in liquid nitrogen and stored in a -80 ° C refrigerator for subsequent determination of CES1 enzyme activity by enzyme-linked immunosorbent assay.
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital Of Chongqing Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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