A Study of Remimazolam Tosilate for Sedation in the ICU

A Multi-center, Randomized, Single-blind, Parallel Controlled With Active Drug, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in the Intensive Care Unit (ICU)

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.

Study Overview

• Status: Completed
• Conditions: Sedation in the ICU
• Intervention / Treatment: Drug: Remimazolam Tosilate; Drug: Propofol Medium and Long Chain Fat Emulsion Injection

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Patients and/or their guardians are able to provide a written informed consent, understand and agree to comply with the study requirements and protocol.
2. Subjects have been treated with endotracheal intubation and mechanical ventilation, and are expected to receive sedation after randomization at least 6 hours. The target sedation level during the period is -2 ≤ RASS ≤ +1.
3. 18 years to 80 years old, male or female.
4. 18 kg/m2 ≤ BMI ≤ 30 kg/m2.

Exclusion Criteria:

1. Deep sedation is required, or continuous sedation is not needed during the study process.
2. Participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation.
3. History of epilepsy or status epilepticus.
4. Myasthenia gravis or a history of myasthenia gravis.
5. Severe arrhythmias or heart disease; the circulatory system is unstable.
6. Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness.
7. Subjects with a history of drug abuse.
8. Organ failure before randomization.
9. Abnormal values of the laboratory examination.
10. Allergic to relevant drugs ingredient or component.
11. Pregnant or nursing women.
12. Subjects who has participated in clinical trials of other interventions recently.
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	Drug: Remimazolam Tosilate; Loading dose: 0.08mg/kg Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1-0.2mg/kg/h
Active Comparator: Propofol Medium and Long Chain Fat Emulsion Injection	Drug: Propofol Medium and Long Chain Fat Emulsion Injection; Loading dose: 0.3-0.5mg/kg Maintenance dose: IV Propofol Medium and Long Chain Fat Emulsion Injection, dose range 0.3-4.0mg/kg/h, increment or decrement of 0.3-0.6mg/kg/h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of sedation success, sedation success is defined as the percentage of time maintaining target sedation in the entire drug administering time ≥ 70% without rescue sedation.	within 24 hours after administration of research drug

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of time maintaining target sedation in the entire drug administering time.	within 24 hours after administration of research drug
Percentage of subjects receiving rescue sedation	within 24 hours after administration of research drug
The number of additional doses of the research drug	within 24 hours after administration of research drug]
The total dosage of Fentanyl	within 24 hours after administration of research drug
Wake-up time.	within 6 hours after stopping the research drug
Stopping the research drug to extubation time.	within 6 hours after stopping the research drug
Nursing scale score	follow-up period (approx. 5-10 minutes)

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Actual): August 13, 2024
• Study Completion (Actual): September 24, 2024

Study Registration Dates

• First Submitted: December 28, 2023
• First Submitted That Met QC Criteria: January 15, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Propofol
• Other Study ID Numbers: HR7056-302

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