A Study of Remimazolam Tosilate for Prolonged Sedation in the ICU

Evaluating the Efficacy and Safety of Remimazolam Tosilate for Injection for Prolonged Mechanical Ventilation Sedation in the Intensive Care Unit (ICU) - A Non-randomized, Multicenter, Single-arm, Open-label, Proof-of-concept, Phase I/II Clinical Trial

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for prolonged sedation(≥72h) during mechanical ventilation in the ICU.

Study Overview

• Status: Completed
• Conditions: Sedation in the ICU
• Intervention / Treatment: Drug: Remimazolam Tosilate

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Guizhou
    • Guiyang, Guizhou, China, 550001
      • The Affiliated Hospital of Guizhou Medical University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Patients or their guardians are able to provide a written informed consent
2. Subjects have been treated with endotracheal intubation and mechanical ventilation, and is expected to receive sedation after randomization. The target level and duration of sedation meet the criteria
3. Age ≥ 18 and ≤ 80 years, male or female
4. Body mass index (BMI) > 18 and < 30 kg/m2

Exclusion Criteria:

1. participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation；
2. Suffering from mental disorders (such as schizophrenia, depression, etc.) and cognitive dysfunction;
3. Organ failure during screening period；
4. Subjects who were receiving dialysis during the screening period or who were expected to require dialysis treatment during the study period;
5. History of epilepsy or status epilepticus;
6. Subjects with a history of drug abuse；
7. Myasthenia gravis or a history of myasthenia gravis;
8. severe arrhythmias or heart disease;
9. Subjects after neurosurgery operation；
10. participants who did not require continuous sedation during mechanical ventilation for endotracheal intubation;
11. Abnormal values of the laboratory examination
12. Subjects who required vasopressor medication to maintain normotensive blood pressure during the screening period (excluding subjects who used vasopressor medication only during surgery);
13. Allergic to relevant drugs ingredient or component;
14. Pregnant or nursing women;
15. Subjects who has participated in clinical trials of other interventions recently;
16. Other conditions deemed unsuitable to be included.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam Tosilate; IV of Remimazolam Tosilate	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

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 72 hours after administration of research drug

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of nursing difficulty.	follow-up period (approx. 5-10 minutes)
Mechanical ventilation time.	at the time of extubation
Percentage of time maintaining target sedation in the entire drug administering time.	within 72 hours after administration of research drug
Percentage of subjects receiving rescue sedation and the average dosage of rescue sedation	within 72 hours after administration of research drug
Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesia	within 72 hours after administration of research drug
Wake-up time.	after stopping the research drug

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2023
• Primary Completion (Actual): March 5, 2025
• Study Completion (Actual): March 5, 2025

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: September 1, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HR7056-206

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