A Study of Remimazolam Tosilate for Sedation in the ICU

Hengrui Medicine

Status and phase: Not yet enrolling; Phase 3

Conditions: Sedation in the ICU

Treatments: Drug: Propofol Medium and Long Chain Fat Emulsion Injection; Drug: Remimazolam Tosilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT06222294

HR7056-302

Details and patient eligibility

About

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

Enrollment: 214 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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. 18 Years to 80 Years Old, male or female；
4. 18 kg/m2≤BMI≤30kg/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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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214 participants in 2 patient groups

Remimazolam Tosilate for Injection

Experimental group

Treatment:

Drug: Remimazolam Tosilate

Propofol Medium and Long Chain Fat Emulsion Injection

Active Comparator group

Treatment:

Drug: Propofol Medium and Long Chain Fat Emulsion Injection