Using Remimazolam Tosilate for prolonged sedation in ICU patients

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

This study is testing if a new medication called Remimazolam Tosilate can safely keep ICU patients who are on a ventilator sedated for up to 72 hours.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Guiyang, Guizhou)
• Trial ID: NCT05913336 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of Remimazolam Tosilate for Injection in providing prolonged sedation for patients undergoing mechanical ventilation in the ICU. It aims to assess how well this medication can maintain sedation for at least 72 hours while ensuring patient safety. The study involves patients who have been intubated and are expected to require sedation after being randomized into the trial. Participants will be monitored closely for both effectiveness and any potential side effects during the sedation period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who require sedation after intubation and mechanical ventilation.

Not a fit: Patients with severe mental disorders, organ failure, or those requiring dialysis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve sedation management in ICU patients, leading to better outcomes during mechanical ventilation.

How similar studies have performed: Other studies have explored sedation methods in ICU settings, but the specific use of Remimazolam Tosilate for prolonged sedation is relatively novel.

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.

Where this trial is running

Guiyang, Guizhou

• The Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China (Recruiting)

Study contacts

• Study coordinator: Qin Liu, M.M

Conditions Sedation in the ICU