A Study of Remimazolam Tosilate for Sedation in Non-intubated Diagnostic and Therapeutic Procedures

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Sedation in Non-intubated Diagnostic and Therapeutic Procedures
• Intervention / Treatment: Drug: Remimazolam Tosilate for Injection; Drug: Remimazolam Tosilate for Injection

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Qin Liu; Phone Number: +0518-82342973; Email: qin.liu@hengrui.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital, Fudan University
      • Principal Investigator: Changhong Miao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years old, male or female
2. Intending to undergo routine gastroscopy or colonoscopy
3. ASA (American Society of Anesthesiologists) I to III
4. 18 kg/m2≤BMI (Body Mass Index)≤30kg/m2
5. Signed informed consent

Exclusion Criteria:

1. Subjects need to be tracheal intubation
2. Subjects need to be complicated endoscopic diagnostic and therapeutic procedures
3. Subjects who have had severe cardiovascular diseases or severe arrhythmias within 6 months prior to signing the ICF
4. Heart rate <50 beats/min during the screening period
5. Poor blood pressure control during the screening period
6. Subjects with severe respiratory diseases
7. Subjects with respiratory management difficulties (Modified Mallampati grade IV)
8. Subjects with a history of mental illness (schizophrenia, mania, bipolar disorder, psychosis, etc.), long-term use of psychotropic drugs, and cognitive impairment
9. A history of drug abuse or addiction within 2 years prior to signing the ICF
10. Pregnant women or those in lactation period
11. Allergic to relevant drugs ingredient or component in the study
12. Currently participating in or planning to participate in other drug or device clinical trials during this study
13. Other conditions deemed unsuitable to be included

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam Tosilate for Injection（5mg）	Drug: Remimazolam Tosilate for Injection; Initial loading dose of 5mg, with additional doses of 2.5mg as necessary; Drug: Remimazolam Tosilate for Injection; Initial loading dose of 10mg, with additional doses of 2.5mg as necessary
Experimental: Remimazolam Tosilate for Injection（10mg）	Drug: Remimazolam Tosilate for Injection; Initial loading dose of 5mg, with additional doses of 2.5mg as necessary; Drug: Remimazolam Tosilate for Injection; Initial loading dose of 10mg, with additional doses of 2.5mg as necessary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of sedation success, Sedation success	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.	day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of additional administrations.	day 1
Percentage of subjects needing additional administration.	day 1
One-time success rate of endoscope insertion during the diagnostic and therapeutic procedure.	day 1
Rate of over-sedation.	day 1
Sedation induction time	day 1
Wake-up time.	day 1
Time to discharge.	day 1
Rate of sedation-related hypotension and rate of sedation-related hypotension needing treatment.	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
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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: December 27, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HR7056-401

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