None listed
Conditions
Interventions
Remazolam low-dose group:Rimazolam load dose 0.05mg/kg
Remazolam high-dose group:Rimazolam load dose 0.1mg/kg
Propofol group:Propofol load dose 1mg/kg
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The subjects clearly understand and voluntarily participate in this research, sign the informed consent form themselves, and voluntarily abide by the research process; 2. Elective local anesthesia surgery; 3. The operation is performed in the operating room, and the estimated duration of the operation is more than 30 minutes; 4. Aged 18-65 years, gender is not limited; 5. BMI 18-28kg/m^2; 6. ASA is grade I-II.
Exclusion criteria
Exclusion criteria: 1. Respiratory and/or pulmonary diseases that are not suitable for participating in the research as assessed by the investigator: (1) Those who are expected to be difficult to intubate; (2) Suffering from sleep apnea syndrome; 2. Subjects who have received general anesthesia within 7 days before randomization; 3. History of arrhythmia such as bradycardia (heart rate =160mmHg or =100mmHg or =11.1 mmol/L during the screening period); 7. Abnormal liver function during the screening period: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >=1.5xULN and/or total bilirubin (TBIL) >=1.5xULN; 8. Abnormal renal function during the screening period: serum creatinine (Cr) >= 1.5xULN; 9. Abnormal coagulation function during the screening period: prolonged prothrombin time (PT) > ULN+3s and/or prolonged activated partial thromboplastin time (APTT) >ULN+10s; 10. Abnormal platelet count during screening: platelet count <50x10^9/L; 11. During the screening period, the infectious disease screening test is positive for syphilis antibody and human immunodeficiency virus (HIV) antibody; 12. Those who are allergic to remazolam, propofol, fentanyl and other drug ingredients or components that may be used in the research; 13. Subjects who may affect the efficacy and safety evaluation due to alcohol, drug and drug withdrawal during the study; 14. Subjects who are pregnant or breastfeeding; 15. Expected to receive interventional surgery; 16. Participated in clinical trials of other drugs within 3 months before the screening period (defined as receiving investigational drugs or placebo); 17. Other situations in which the researcher judges that the subject is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to maintain target sedation (MOAA/S grades 1-4) as a percentage of total study dosing time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving target sedation within 5 minutes of starting infusion of investigational drug;Time from start of investigational drug infusion to first achievement of target sedation; | — |
Countries
China
Contacts
Public ContactLiu Jin
West China Hospital of Sichuan University
Outcome results
None listed