A Temporal Variability Study of Remimazolam for General Anesthesia Induction and Maintenance

NCT07079800 | Active Not Recruiting

• 1 other identifier: 2025-120
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Biological Rhythm; Drug Metabolism and Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  Within two weeks after the operation

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• Age 18-75 years old, ASAI-III class;
• Inpatients undergoing laparoscopic partial hepatic resection;
• Voluntary participation and signed informed consent.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Jie Chen: lead

Study Sites (1)

The Second Affiliated Hospital Of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 23, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)