Clinical trial NCT05152303: A Study of Remimazolam Tosilate for Sedation in the ICU
Official title: Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in the Intensive Care Unit (ICU) - a Multicenter, Randomized, Single Blind, Dose Finding Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sedation in the ICU
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Multicenter, Randomized, Single Blind, Dose Finding, Phase II Clinical Trial 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
Primary purpose: TREATMENT

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.


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. 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

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 and the average dosage of rescue sedation
timeFrame: within 24 hours after administration of research drug
measure: Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesiaassessment time point after drug administering.
timeFrame: within 24 hours after administration of research drug
measure: The number of times to change the infusion rate
timeFrame: within 24 hours after administration of research drug
measure: Wake-up time.
timeFrame: within 8 hours after stopping the research drug
measure: Evaluation of nursing difficulty.
timeFrame: follow-up period (approx. 5-10 minutes)
measure: Mechanical ventilation time.
timeFrame: at the time of extubation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References: