Clinical trial NCT05015361: A Trial of Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation
Official title: Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation -- a Multicenter, Randomized, Single Blind, Positive Drug Parallel Controlled Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Local Anesthesia Assisted Sedation
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-20
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Remimazolam Tosilate compared with Propofol Injection
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The time to maintain target sedation as a percentage of the total study administration time.
timeFrame: through study completion,an average of about 1 hour
Secondary outcomes:
measure: Proportion of subjects who achieved target sedation within 3 minutes after starting intravenous injection of load dose test drugs;
timeFrame: 3 minutes after administration
measure: Proportion of subjects receiving remedial sedation;
timeFrame: through study completion,an average of about 1 hour
measure: The time from the start of intravenous injection of load dose test drug to the first achievement of target sedation;
timeFrame: Time to achieve target sedation, an average of about 4 minutes
measure: The time from stopping infusion of test drugs to reaching MOAA/S level 5 for the first time after operation
timeFrame: Recovery time, an average of about 7 minutes
measure: Anesthesiologists' satisfaction with sedation
timeFrame: through study completion,an average of about 1 hour
measure: Evaluation of subjects' satisfaction with sedation treatment;
timeFrame: through study completion,an average of about 1 hour
measure: Incidence of anterograde amnesia.
timeFrame: through study completion,an average of about 1 hour
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References: