A Study of Remimazolam Tosilate for Prolonged Sedation in the ICU

Phase 1

Recruiting

• Conditions: Sedation in the ICU
• Interventions: Drug: Remimazolam Tosilate

• Registration Number: NCT05913336
• 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 prolonged sedation(≥72h) during mechanical ventilation in the ICU.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-22
• Study Start: 2023-06-27
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-28
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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. Age ≥ 18 and ≤ 80 years, male or female
4. Body mass index (BMI) > 18 and < 30 kg/m2

Exclusion Criteria

1. participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation；
2. Suffering from mental disorders (such as schizophrenia, depression, etc.) and cognitive dysfunction;
3. Organ failure during screening period；
4. Subjects who were receiving dialysis during the screening period or who were expected to require dialysis treatment during the study period;
5. History of epilepsy or status epilepticus;
6. Subjects with a history of drug abuse；
7. Myasthenia gravis or a history of myasthenia gravis;
8. severe arrhythmias or heart disease;
9. Subjects after neurosurgery operation；
10. participants who did not require continuous sedation during mechanical ventilation for endotracheal intubation;
11. Abnormal values of the laboratory examination
12. Subjects who required vasopressor medication to maintain normotensive blood pressure during the screening period (excluding subjects who used vasopressor medication only during surgery);
13. Allergic to relevant drugs ingredient or component;
14. Pregnant or nursing women;
15. Subjects who has participated in clinical trials of other interventions recently;
16. Other conditions deemed unsuitable to be included.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remimazolam Tosilate	Remimazolam Tosilate	IV of 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 72 hours after administration of research drug

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesia	within 72 hours after administration of research drug
Mechanical ventilation time.	at the time of extubation
Evaluation of nursing difficulty.	follow-up period (approx. 5-10 minutes)
Wake-up time.	after stopping the research drug
Percentage of subjects receiving rescue sedation and the average dosage of rescue sedation	within 72 hours after administration of research drug
Percentage of time maintaining target sedation in the entire drug administering time.	within 72 hours after administration of research drug

Trial Locations

Locations (1)

The Affiliated Hospital of Guizhou Medical University; 🇨🇳 Guiyang, Guizhou, China