CompletedPhase 1/2

A Study of Remimazolam Tosilate for Prolonged Sedation in the ICU

China24 participantsStarted 2023-06-27

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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;

What they're measuring

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.

Timeframe: within 72 hours after administration of research drug

Trial details

NCT IDNCT05913336

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-05

View on ClinicalTrials.gov More Sedation in the ICU trials