Local Anesthesia Assisted Sedation
Conditions
Brief summary
To evaluate the efficacy and safety of Remimazolam Tosilate for injection in local anesthesia assisted sedation, and to explore the dose range of remazolam toluenesulfonate for injection in local anesthesia assisted sedation.
Interventions
Treatment group A: Remimazolam Tosilate; high dose Treatment group B: Remimazolam Tosilate; low dose
DRUGPropofol Injection.
Treatment group C: Propofol Injection.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Remimazolam Tosilate compared with Propofol Injection
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide a written informed consent 2. Subjects requiring local anesthesia assisted sedation 3. Male or female 4. Meet the weight standard 5. Conform to the ASA Physical Status Classification
Exclusion criteria
1. Previous respiratory or pulmonary diseases 2. Subjects who had received general anesthesia 3. Subjects with a history of myocardial infarction or unstable angina pectoris 4. Subjects with atrioventricular block or cardiac insufficiency 5. Subjects with a history of ischemic stroke or transient ischemic attack 6. Subjects with poor blood pressure control after medication 7. Subjects with abnormal clotting function 8. Subjects with a history of mental illness and a history of cognitive impairment epilepsy 9. Subjects with a history or possibility of a difficult airway 10. Subject with a history of substance abuse and drug abuse 11. Abnormal values in the laboratory 12. Allergic to a drug ingredient or component 13. Pregnant or nursing women 14. No birth control during the specified period of time 15. Participated in clinical trials of other drugs (received experimental drugs) 16. The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to maintain target sedation as a percentage of the total study administration time. | through study completion,an average of about 1 hour |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects receiving remedial sedation; | through study completion,an average of about 1 hour |
| The time from the start of intravenous injection of load dose test drug to the first achievement of target sedation; | Time to achieve target sedation, an average of about 4 minutes |
| The time from stopping infusion of test drugs to reaching MOAA/S level 5 for the first time after operation | Recovery time, an average of about 7 minutes |
| Proportion of subjects who achieved target sedation within 3 minutes after starting intravenous injection of load dose test drugs; | 3 minutes after administration |
| Evaluation of subjects' satisfaction with sedation treatment; | through study completion,an average of about 1 hour |
| Incidence of anterograde amnesia. | through study completion,an average of about 1 hour |
| Anesthesiologists' satisfaction with sedation | through study completion,an average of about 1 hour |
Countries
China
Outcome results
None listed