Assessing the safety and effectiveness of remazolam besylate for sedation in critically ill patients on ventilators after surgery
Efficacy and Safety of Remazolam Besylate in Patients Requiring Mechanical Ventilation Admitted to ICU After Non-cardiac Surgery: Protocol for a Randomized, Controlled No-inferiority Trial
This study is testing if a new sedative called remazolam besylate is safe and effective for helping critically ill patients on ventilators after surgery, compared to a standard sedative.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 306 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Beijing Shijitan Hospital, Capital Medical University Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06575530 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multi-center, prospective, randomized, double-blind, no-inferiority study aimed at evaluating the safety and efficacy of remazolam besylate compared to dexmedetomidine for sedation in critically ill patients who are mechanically ventilated following elective surgery. Participants will be adults aged 18-64 who require light to moderate sedation and have been admitted to the ICU with tracheal intubation. The study will focus on measuring the effectiveness of sedation and monitoring for any adverse drug events during the mechanical ventilation period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-64 who are undergoing non-cardiac elective surgery and require mechanical ventilation post-operatively.
Not a fit: Patients with severe neurological conditions, significant cardiac dysfunction, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective sedation option for critically ill patients requiring mechanical ventilation after surgery.
How similar studies have performed: While there have been studies on sedation in critically ill patients, the specific use of remazolam besylate in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-64 years old * must accept no-cardiac elective surgery * must under general anaesthesia * can be combined regional tissue anesthesia * must admitted to ICU with tracheal intubation after general anaesthesia - expected mechanical ventilation time must more than 24 hours * light or moderate sedation must needed Exclusion Criteria: * intracranial surgery or severe neurological or spinal cord disease * schizophrenia, epilepsy, and Parkinson's disease * coma, severe dementia, or language barrier before surgery * cardiac dysfunction or arrhythmia * severe liver dysfunction(Child-Pugh C class) * severe kidney dysfunction * use of dexmedetomidine or remifentanil besylate 24 hours before or during surgery * pregnancy or lactation * any investigational drug useage 30 days before surgery * refuse to participant.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Shijitan Hospital.CMU — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yuefu Wang, doctor
- Email: wangyuefu3806@bjsjth.cn
- Phone: +86
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.