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Clinical trial

Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in the Intensive Care Unit (ICU) - a Multicenter, Randomized, Single Blind, Dose Finding Phase II Clinical Trial

ID
Name
HR7056-205
Description
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.
Trial arms
Trial start
2022-10-12
Estimated PCD
2023-04-02
Trial end
2023-04-19
Status
Completed
Phase
Early phase I
Treatment
Remimazolam Tosilate
Loading dose: 0.08mg/kg IV of Remimazolam Tosilate, Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1mg/kg/h
Arms:
A：Remimazolam Tosilate
Remimazolam Tosilate
Loading dose: 0.08mg/kg, Drug: Propofol Injection Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.2mg/kg/h IV of Propofol Injection
Arms:
B：Remimazolam Tosilate
Size
60
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
within 24 hours after administration of research drug
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a Multicenter, Randomized, Single Blind, Dose Finding, Phase II Clinical Trial 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', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2023-05-23

1 organization

1 product

1 indication

Organization
Fujian Shengdi Pharmaceutical
Product
Remimazolam
Indication
ICU Sedation