Clinical trial
A Multi-center, Randomized, Single-blind, Parallel Controlled With Active Drug, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in the Intensive Care Unit (ICU)
Name
HR7056-302
Description
The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.
Trial arms
Trial start
2024-01-01
Estimated PCD
2025-01-01
Trial end
2025-01-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Remimazolam Tosilate
Loading dose: 0.08mg/kg Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1-0.2mg/kg/h
Arms:
Remimazolam Tosilate for Injection
Propofol Medium and Long Chain Fat Emulsion Injection
Loading dose: 0.3-0.5mg/kg Maintenance dose: IV Propofol Medium and Long Chain Fat Emulsion Injection, dose range 0.3-4.0mg/kg/h, increment or decrement of 0.3-0.6mg/kg/h
Arms:
Propofol Medium and Long Chain Fat Emulsion Injection
Size
214
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. 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 214, 'type': 'ESTIMATED'}}
Updated at
2024-01-24
1 organization
3 products
1 indication
Product
RemimazolamIndication
ICU SedationProduct
PropofolOrganization
Jiangsu HengRui Medicine