A Study of Remimazolam Tosilate for Sedation in the ICU

Phase 2

Completed

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

• Registration Number: NCT05152303
• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-11-29
• Study First Posted: 2021-12-09
• Study Start: 2022-10-12
• Status Verified: 2023-04
• Primary Completion: 2023-04-02
• Study Completion: 2023-04-19
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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. Meet the age criteria, male or female
4. Meet the BMI criteria

Exclusion Criteria

1. Deep sedation is required, or continuous sedation is not needed during the study process
2. Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness
3. Subjects with a history of drug abuse
4. Subjects after neurosurgery operation
5. Organ failure before randomization
6. Abnormal values of the laboratory examination
7. Abnormal blood pressure and heart rate during screening
8. Allergic to relevant drugs ingredient or component
9. Pregnant or nursing women
10. Subjects who has participated in clinical trials of other interventions recently

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A：Remimazolam Tosilate	Remimazolam Tosilate	-
B：Remimazolam Tosilate	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
Mechanical ventilation time.	at the time of extubation
Percentage of subjects receiving rescue sedation and the average dosage of rescue sedation	within 24 hours after administration of research drug
Percentage of time maintaining target sedation in the entire drug administering time.	within 24 hours after administration of research drug
The number of times to change the infusion rate	within 24 hours after administration of research drug
Evaluation of nursing difficulty.	follow-up period (approx. 5-10 minutes)
Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesiaassessment time point after drug administering.	within 24 hours after administration of research drug
Wake-up time.	within 8 hours after stopping the research drug

Trial Locations

Locations (1)

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