A Study of Remimazolam Tosilate for Sedation in the ICU
NCT ID: NCT06222294
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
214 participants
INTERVENTIONAL
2024-03-12
2024-09-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Remimazolam Tosilate for Injection
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
Propofol Medium and Long Chain Fat Emulsion 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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 18 years to 80 years old, male or female.
4. 18 kg/m2 ≤ BMI ≤ 30 kg/m2.
Exclusion Criteria
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.
18 Years
80 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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HR7056-302
Identifier Type: -
Identifier Source: org_study_id
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