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

NCT05015361 | Completed Phase 2

• 1 other identifier: HR7056-204
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Local Anesthesia Assisted Sedation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

Treatment group A/B

EXPERIMENTAL

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

Drug: Remimazolam Tosilate

Treatment group C

ACTIVE COMPARATOR

Treatment group C: Propofol Injection.

Drug: Propofol Injection.

Interventions

Remimazolam Tosilate DRUG

Treatment group A: Remimazolam Tosilate; high dose Treatment group B: Remimazolam Tosilate; low dose

Treatment group A/B

Propofol Injection. DRUG

Treatment group C: Propofol Injection.

Treatment group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent
• Subjects requiring local anesthesia assisted sedation
• Male or female
• Meet the weight standard
• Conform to the ASA Physical Status Classification

You may not qualify if:

• Previous respiratory or pulmonary diseases
• Subjects who had received general anesthesia
• Subjects with a history of myocardial infarction or unstable angina pectoris
• Subjects with atrioventricular block or cardiac insufficiency
• Subjects with a history of ischemic stroke or transient ischemic attack
• Subjects with poor blood pressure control after medication
• Subjects with abnormal clotting function
• Subjects with a history of mental illness and a history of cognitive impairment epilepsy
• Subjects with a history or possibility of a difficult airway
• Subject with a history of substance abuse and drug abuse
• Abnormal values in the laboratory
• Allergic to a drug ingredient or component
• Pregnant or nursing women
• No birth control during the specified period of time
• Participated in clinical trials of other drugs (received experimental drugs)

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Remimazolam Tosilate compared with Propofol Injection

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 20, 2021
• Study Start: May 7, 2021
• Primary Completion: June 18, 2021
• Study Completion: July 4, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

CN (1)