A Study of Remimazolam Tosilate for Sedation in the ICU

Phase 3

Completed

• Conditions: Sedation in the ICU
• Interventions: Drug: Propofol Medium and Long Chain Fat Emulsion Injection; Drug: Remimazolam Tosilate

• Registration Number: NCT06222294
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-28
• Study First Submitted QC: 2024-01-15
• Study First Posted: 2024-01-24
• Study Start: 2024-03-12
• Status Verified: 2024-08
• Primary Completion: 2024-08-13
• Study Completion: 2024-09-24
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol Medium and Long Chain Fat Emulsion Injection	Propofol Medium and Long Chain Fat Emulsion Injection	-
Remimazolam Tosilate for Injection	Remimazolam Tosilate	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Percentage of time maintaining target sedation in the entire drug administering time.	within 24 hours after administration of research drug
Percentage of subjects receiving rescue sedation	within 24 hours after administration of research drug
Wake-up time.	within 6 hours after stopping the research drug
The number of additional doses of the research drug	within 24 hours after administration of research drug]
The total dosage of Fentanyl	within 24 hours after administration of research drug
Stopping the research drug to extubation time.	within 6 hours after stopping the research drug
Nursing scale score	follow-up period (approx. 5-10 minutes)

Trial Locations

Locations (1)

The First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China