A Study of Remimazolam Tosilate for Sedation in the ICU

Fujian Shengdi Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Sedation in the ICU

Treatments: Drug: Remimazolam Tosilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT05152303

HR7056-205

Details and patient eligibility

About

The purpose of this study is to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.

Enrollment: 60 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. Meet the age criteria, male or female
4. Meet the BMI criteria

Exclusion criteria

1. Deep sedation is required, or continuous sedation is not needed during the study process
2. Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness
3. Subjects with a history of drug abuse
4. Subjects after neurosurgery operation
5. Organ failure before randomization
6. Abnormal values of the laboratory examination
7. Abnormal blood pressure and heart rate during screening
8. Allergic to relevant drugs ingredient or component
9. Pregnant or nursing women
10. Subjects who has participated in clinical trials of other interventions recently

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

A：Remimazolam Tosilate

Experimental group

Treatment:

Drug: Remimazolam Tosilate

Drug: Remimazolam Tosilate

B：Remimazolam Tosilate

Experimental group

Treatment:

Drug: Remimazolam Tosilate

Drug: Remimazolam Tosilate