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

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

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.

Study Overview

• Status: Completed
• Conditions: Local Anesthesia Assisted Sedation
• Intervention / Treatment: Drug: Remimazolam Tosilate; Drug: Propofol Injection.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A/B; Treatment group A: Remimazolam Tosilate Treatment group B: Remimazolam Tosilate	Drug: Remimazolam Tosilate; Treatment group A: Remimazolam Tosilate; high dose Treatment group B: Remimazolam Tosilate; low dose
Active Comparator: Treatment group C; Treatment group C: Propofol Injection.	Drug: Propofol Injection.; Treatment group C: Propofol Injection.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects who achieved target sedation within 3 minutes after starting intravenous injection of load dose test drugs;	3 minutes after administration
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
Anesthesiologists' satisfaction with sedation	through study completion,an average of about 1 hour
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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2021
• Primary Completion (Actual): June 18, 2021
• Study Completion (Actual): July 4, 2021

Study Registration Dates

• First Submitted: August 11, 2021
• First Submitted That Met QC Criteria: August 15, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 15, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: HR7056-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No