Biological RhythmNCT07079800
A Temporal Variability Study of Remimazolam for General Anesthesia Induction and Maintenance
An observational study of Biological Rhythm and Drug Metabolism and Pharmacokinetics, run by Jie Chen at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Biological Rhythm, Drug Metabolism and Pharmacokinetics
- How many people
- 188 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2025to 20 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Experiment 1: Measurement Experiment of Remimazolam Blood Concentration and Dosage
- Age 18-65 years old, ASAI-II class, BMI18.5-25kg/m^2;
- Inpatients undergoing laparoscopic cholecystectomy;
- The estimated time of operation is 1.5~2.5 hours;
- Voluntary participation and signed informed consent.
- Experiment 2: Remimazolam metabolic enzyme CES1 activity measurement experiment
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- Age 18-75 years old, ASAI-III class;
- Inpatients undergoing laparoscopic partial hepatic resection;
- Voluntary participation and signed informed consent.
Who cannot join
- Experiment 1:Measurement Experiment of Remimazolam Blood Concentration and Dosage
- Pregnant or lactating women;
- Patients who are allergic to remazolam or contraindicated;
- Patients who are dependent on or tolerant to opioids or have long-term alcoholism;
- Serious cardiovascular system, respiratory system, liver and kidney diseases;
- History of obstructive sleep apnea;
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- Mental disorders or neurological diseases;
- Patients who participated in clinical trials of other drugs within the last 3 months;
- The attending physician or researcher considers that there are other circumstances that are not suitable for participation in this study;
- Refuse to participate in the study
- Experiment 2: Remimazolam metabolic enzyme CES1 activity measurement experiment
- Pregnant or lactating women;
- Patients who are allergic to remazolam or contraindicated;
- Patients who are dependent on or tolerant to opioids or have long-term alcoholism;
- Serious cardiovascular system, respiratory system;
- History of obstructive sleep apnea;
- Mental disorders or neurological diseases;
- Patients who participated in clinical trials of other drugs within the last 3 months;
- The attending physician or researcher considers that there are other circumstances that are not suitable for participation in this study;
- Refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital Of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
About this study
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.
Read the detailed description
This study is a single-blind, prospective cohort study. It is mainly divided into two parts: 1. Detection of the blood concentration and dosage differences of remimazolam: Patients who were scheduled to undergo laparoscopic cholecystectomy under general anesthesia were included. The patients were divided into the morning group (operation time 8:00-12:00) and the afternoon group (operation time 14:00-18:00) according to the operation time. The blood concentration of remimazolam after anesthesia induction was measured, and the influence of time rhythm on the pharmacokinetics of remimazolam was statistically analyzed. The dosage of remimazolam used during anesthesia maintenance was measured, and statistical analysis was conducted on whether there were dosage differences and the temporal rhythm of drug efficacy of remimazolam during the maintenance process. 2. CES1 Activity detection: Patients who were scheduled to undergo laparoscopic partial hepatectomy under general anesthesia were included. The research subjects were divided into the morning group (8:00-12:00) and the afternoon group (14:00-18:00) based on the liver tissue sampling time. The activity of carboxylate esterase 1 (CES1) in the normal tissues adjacent to liver cancer in patients at different time points was measured. Analyze the influence of time rhythm on the drug metabolism of remimazolam. The effects of time rhythm on the pharmacokinetics and pharmacodynamics of remimazolam were jointly verified from three aspects: blood drug concentration, drug dosage, and CES1 activity.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam blood concentration and dosage measurement experiment Morning group | Not described | |
| Remimazolam blood concentration and dosage measurement experiment Afternoon group | Not described | |
| Remimazolam metabolic enzyme CES1 activity measurement experiment morning group | Not described | |
| Remimazolam metabolizing enzyme CES1 activity measurement experiment afternoon group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remimazolam dosage
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
Measured: During the operation
Remimazolam blood concentration
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.
Measured: Within two weeks after the operation
CES1 activity
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.
Measured: Within two weeks after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start17 Jun 2025
- Primary completion20 Jun 2026 (estimated)
- Study completion20 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biological RhythmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jie Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jie Chen, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079800
- Sponsor's protocol ID
- 2025-120
- Status last verified
- Jul 2025
- First submitted
- 18 Jun 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Temporal Variability Study of Remimazolam for General Anesthesia Induction and Maintenance
- ClinicalTrials.gov ID
- NCT07079800
- Acronym / sponsor ID
- 2025-120
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Jie ChenUniversity, hospital or other
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 20 Jul 2026 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a single-blind, prospective cohort study. It is mainly divided into two parts: 1. Detection of the blood concentration and dosage differences of remimazolam: Patients who were scheduled to undergo laparoscopic cholecystectomy under general anesthesia were included. The patients were divided into the morning group (operation time 8:00-12:00) and the afternoon group (operation time 14:00-18:00) according to the operation time. The blood concentration of remimazolam after anesthesia induction was measured, and the influence of time rhythm on the pharmacokinetics of remimazolam was statistically analyzed. The dosage of remimazolam used during anesthesia maintenance was measured, and statistical analysis was conducted on whether there were dosage differences and the temporal rhythm of drug efficacy of remimazolam during the maintenance process. 2. CES1 Activity detection: Patients who were scheduled to undergo laparoscopic partial hepatectomy under general anesthesia were included. The research subjects were divided into the morning group (8:00-12:00) and the afternoon group (14:00-18:00) based on the liver tissue sampling time. The activity of carboxylate esterase 1 (CES1) in the normal tissues adjacent to liver cancer in patients at different time points was measured. Analyze the influence of time rhythm on the drug metabolism of remimazolam. The effects of time rhythm on the pharmacokinetics and pharmacodynamics of remimazolam were jointly verified from three aspects: blood drug concentration, drug dosage, and CES1 activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Remimazolam blood concentration and dosage measurement experiment Morning group | – | – |
| Remimazolam blood concentration and dosage measurement experiment Afternoon group | – | – |
| Remimazolam metabolic enzyme CES1 activity measurement experiment morning group | – | – |
| Remimazolam metabolizing enzyme CES1 activity measurement experiment afternoon group | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (9 listed)
- Experiment 1: Measurement Experiment of Remimazolam Blood Concentration and Dosage
- Age 18-65 years old, ASAI-II class, BMI18.5-25kg/m^2;
- Inpatients undergoing laparoscopic cholecystectomy;
- The estimated time of operation is 1.5~2.5 hours;
- Voluntary participation and signed informed consent.
Key exclusion criteria (20 listed)
- Experiment 1:Measurement Experiment of Remimazolam Blood Concentration and Dosage
- Pregnant or lactating women;
- Patients who are allergic to remazolam or contraindicated;
- Patients who are dependent on or tolerant to opioids or have long-term alcoholism;
- Serious cardiovascular system, respiratory system, liver and kidney diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Remimazolam dosage
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biological Rhythm and Drug Metabolism and Pharmacokinetics, run by Jie Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remimazolam dosage (time frame: During the operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.