A Trial of Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: Local Anesthesia Assisted Sedation

Treatments: Drug: Remimazolam Tosilate; Drug: Propofol Injection.

Study type: Interventional

Funder types: Industry

Identifiers

NCT05015361

HR7056-204

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 2 patient groups

Treatment group A/B

Experimental group

Description:

Treatment group A: Remimazolam Tosilate Treatment group B: Remimazolam Tosilate

Treatment:

Drug: Remimazolam Tosilate

Treatment group C

Active Comparator group

Description:

Treatment group C: Propofol Injection.

Treatment:

Drug: Propofol Injection.