Status:
COMPLETED
A Study of Remimazolam Tosilate for Sedation in the ICU
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Sedation in the ICU
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.
Eligibility Criteria
Inclusion
- 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
- 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.
- Abnormal values of the laboratory examination.
- Allergic to relevant drugs ingredient or component.
- Pregnant or nursing women.
- Subjects who has participated in clinical trials of other interventions recently.
- Other conditions deemed unsuitable to be included.
Key Trial Info
Start Date :
March 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2024
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT06222294
Start Date
March 12 2024
End Date
September 24 2024
Last Update
January 9 2026
Active Locations (1)
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1
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080