A Multi-center, Randomized, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Remimazolam Tosilate (Ruibeining®) for Injection for Sedation in Non-intubated Diagnostic and Therapeutic Procedures

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country240 target enrollmentJanuary 2024

ConditionsSedation in Non-intubated Diagnostic and Therapeutic Procedures

InterventionsRemimazolam Tosilate for Injection

DrugsRemimazolam Tosilate for Injection

Overview

Phase: Phase 4
Intervention: Remimazolam Tosilate for Injection
Conditions: Sedation in Non-intubated Diagnostic and Therapeutic Procedures
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 240
Locations: 1
Primary Endpoint: Rate of sedation success, Sedation success
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in non-intubated diagnostic and therapeutic procedures

Registry

clinicaltrials.gov

Start Date

January 2024

End Date

March 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years old, male or female
•Intending to undergo routine gastroscopy or colonoscopy
•ASA (American Society of Anesthesiologists) I to III
•18 kg/m2≤BMI (Body Mass Index)≤30kg/m2
•Signed informed consent

Exclusion Criteria

•Subjects need to be tracheal intubation
•Subjects need to be complicated endoscopic diagnostic and therapeutic procedures
•Subjects who have had severe cardiovascular diseases or severe arrhythmias within 6 months prior to signing the ICF
•Heart rate \<50 beats/min during the screening period
•Poor blood pressure control during the screening period
•Subjects with severe respiratory diseases
•Subjects with respiratory management difficulties (Modified Mallampati grade IV)
•Subjects with a history of mental illness (schizophrenia, mania, bipolar disorder, psychosis, etc.), long-term use of psychotropic drugs, and cognitive impairment
•A history of drug abuse or addiction within 2 years prior to signing the ICF
•Pregnant women or those in lactation period

Arms & Interventions

Remimazolam Tosilate for Injection（5mg）

Intervention: Remimazolam Tosilate for Injection

Remimazolam Tosilate for Injection（10mg）

Intervention: Remimazolam Tosilate for Injection

Outcomes

Primary Outcomes

Rate of sedation success, Sedation success

Time Frame: day 1

Rate of sedation success, Sedation success is defined as: 1) Completion of the entire non-intubated diagnostic and therapeutic procedure; 2) No need for additional rescue sedation; 3) During the sedation induction phase, the MOAA/S score should be ≤3 within 2 minutes after the end of the initial dose administration or after ≤2 additional administrations; 4) No more than 2 additional administrations in every 5-minute.

Secondary Outcomes

Percentage of subjects needing additional administration.(day 1)
Participant's satisfaction with Sedation Assessment: The scoring range is from 0 to 10, where 0 represents dissatisfaction and 10 represents complete satisfaction.(day 1)
Number of additional administrations.(day 1)
Sedation induction time(day 1)
Rate of respiratory depression during sedation.(day 1)
Investigator's Satisfaction with Sedation Assessment: The scoring range is from 0 to 10, where 0 represents dissatisfaction and 10 represents complete satisfaction.(day 1)
Wake-up time.(day 1)
Time to discharge.(day 1)
One-time success rate of endoscope insertion during the diagnostic and therapeutic procedure.(day 1)
Rate of over-sedation.(day 1)
Rate of sedation-related hypotension and rate of sedation-related hypotension needing treatment.(day 1)