Clinical trial NCT05913336: A Study of Remimazolam Tosilate for Prolonged Sedation in the ICU
Official title: Evaluating the Efficacy and Safety of Remimazolam Tosilate for Injection for Prolonged Mechanical Ventilation Sedation in the Intensive Care Unit (ICU) - A Non-randomized, Multicenter, Single-arm, Open-label, Proof-of-concept, Phase I/II Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Sedation in the ICU
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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. 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.

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 72 hours after administration of research drug
Secondary outcomes:
measure: Percentage of time maintaining target sedation in the entire drug administering time.
timeFrame: within 72 hours after administration of research drug
measure: Percentage of subjects receiving rescue sedation and the average dosage of rescue sedation
timeFrame: within 72 hours after administration of research drug
measure: Percentage of subjects receiving rescue analgesia and the average dosage of rescue analgesia
timeFrame: within 72 hours after administration of research drug
measure: Wake-up time.
timeFrame: 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: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
Study officials:
References: