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

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country24 target enrollmentJune 27, 2023

ConditionsSedation in the ICU

InterventionsRemimazolam Tosilate

DrugsRemimazolam Tosilate

Overview

Phase: Phase 1
Intervention: Remimazolam Tosilate
Conditions: Sedation in the ICU
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 24
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 8 months 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 prolonged sedation(≥72h) during mechanical ventilation in the ICU.

Registry

clinicaltrials.gov

Start Date

June 27, 2023

End Date

March 5, 2025

Last Updated

8 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients or their guardians are able to provide a written informed consent
•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
•Age ≥ 18 and ≤ 80 years, male or female
•Body mass index (BMI) \> 18 and \< 30 kg/m2

Exclusion Criteria

•participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation；
•Suffering from mental disorders (such as schizophrenia, depression, etc.) and cognitive dysfunction;
•Organ failure during screening period；
•Subjects who were receiving dialysis during the screening period or who were expected to require dialysis treatment during the study period;
•History of epilepsy or status epilepticus;
•Subjects with a history of drug abuse；
•Myasthenia gravis or a history of myasthenia gravis;
•severe arrhythmias or heart disease;
•Subjects after neurosurgery operation；
•participants who did not require continuous sedation during mechanical ventilation for endotracheal intubation;

Arms & Interventions

Remimazolam Tosilate

IV of Remimazolam Tosilate

Intervention: Remimazolam Tosilate

Outcomes

Primary Outcomes

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.

Time Frame: within 72 hours after administration of research drug

Secondary Outcomes

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