Clinical trial NCT06222294: A Study of Remimazolam Tosilate for Sedation in the ICU
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sedation in the ICU
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-24
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: 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.
timeFrame: within 24 hours after administration of research drug
Secondary outcomes:
measure: Percentage of time maintaining target sedation in the entire drug administering time.
timeFrame: within 24 hours after administration of research drug
measure: Percentage of subjects receiving rescue sedation
timeFrame: within 24 hours after administration of research drug
measure: The number of additional doses of the research drug
timeFrame: within 24 hours after administration of research drug]
measure: The total dosage of Fentanyl
timeFrame: within 24 hours after administration of research drug
measure: Wake-up time.
timeFrame: within 6 hours after stopping the research drug
measure: Stopping the research drug to extubation time.
timeFrame: within 6 hours after stopping the research drug
measure: Nursing scale score
timeFrame: follow-up period (approx. 5-10 minutes)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References: