CompletedPhase 3

A Study of Remimazolam Tosilate for Sedation in the ICU

China214 participantsStarted 2024-03-12

Plain-language summary

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

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Patients and/or their guardians are able to provide a written informed consent, understand and agree to comply with the study requirements and protocol.
✓. 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.
✓. 18 years to 80 years old, male or female.
✓. 18 kg/m2 ≤ BMI ≤ 30 kg/m2.

Exclusion criteria

✕. Deep sedation is required, or continuous sedation is not needed during the study process.
✕. Participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation.
✕. History of epilepsy or status epilepticus.
✕. Myasthenia gravis or a history of myasthenia gravis.
✕. Severe arrhythmias or heart disease; the circulatory system is unstable.
✕. Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness.
✕. Subjects with a history of drug abuse.
✕. Organ failure before randomization.

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 24 hours after administration of research drug

Trial details

NCT IDNCT06222294

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-13

View on ClinicalTrials.gov More Sedation in the ICU trials