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

Phase 2

Completed

• Conditions: Local Anesthesia Assisted Sedation
• Interventions: Drug: Propofol Injection.; Drug: Remimazolam Tosilate

• Registration Number: NCT05015361
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-07
• Primary Completion: 2021-06-18
• Study Completion: 2021-07-04
• Status Verified: 2021-08
• Study First Submitted: 2021-08-11
• Study First Submitted QC: 2021-08-15
• Last Update Submitted: 2021-08-15
• Study First Posted: 2021-08-20
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group C	Propofol Injection.	Treatment group C: Propofol Injection.
Treatment group A/B	Remimazolam Tosilate	Treatment group A: Remimazolam Tosilate Treatment group B: Remimazolam Tosilate

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Evaluation of subjects' satisfaction with sedation treatment;	through study completion,an average of about 1 hour
Proportion of subjects who achieved target sedation within 3 minutes after starting intravenous injection of load dose test drugs;	3 minutes after administration
Anesthesiologists' satisfaction with sedation	through study completion,an average of about 1 hour
Incidence of anterograde amnesia.	through study completion,an average of about 1 hour
Proportion of subjects receiving remedial sedation;	through study completion,an average of about 1 hour

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China