Using Remimazolam Besylate for Sedation in ICU Patients After Oral Surgery

RemImazolam Besylate for ICU-sedation in Patients With Mechanical Ventilation After Oral and Maxillofacial Surgery: Multicenter, Randomized, Non-inferiority Clinical Study

This study is testing if a new sedation drug called remimazolam can safely help patients in the ICU after oral surgery feel relaxed without affecting their breathing, compared to standard sedatives.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 285 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (other)
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT05606315 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and effectiveness of remimazolam besylate, an ultra-short-acting benzodiazepine, for sedation in mechanically ventilated patients following oral and maxillofacial surgery. The trial aims to determine if remimazolam can provide rapid and reversible sedation without respiratory depression, thereby potentially shortening the duration of mechanical ventilation. Patients will be monitored closely in the ICU to assess sedation levels and any adverse effects. The study compares remimazolam to traditional sedatives like propofol and midazolam.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who require mechanical ventilation after oral and maxillofacial surgery and expect to stay in the ICU for less than 72 hours.

Not a fit: Patients who are pregnant, have severe heart conditions, or a history of long-term benzodiazepine or opioid use may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved sedation management and faster recovery for patients after major oral surgeries.

How similar studies have performed: Previous studies have shown promising results with remimazolam in other sedation contexts, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years old;
* After undergoing oral and maxillofacial surgery, it is expected that a ventilator will be needed to assist with breathing;
* mechanical ventilation patients with expected ICU stay time \<72h;
* People who need immediate sedative treatment;
* Obtain informed consent from subject or legal representative;

Exclusion Criteria:

* Pregnancy；
* Can not get RASS score from patients;
* Allergy to drugs;
* Proven acute and severe intracranial or spinal nerve disease due to vascular, infection, intracranial dilation, or injury;
* Uncompensated acute circulatory failure at randomization (severe hypotension with MAP\<50 mmHg despite adequate fluid resuscitation and vasopressor therapy);
* Severe bradycardia (heart rate \<50 beats/min) or degree II-III heart block (unless a pacemaker is installed);
* A history of long-term use of benzodiazepines or opioids;
* Subjects receiving sedation for indications other than to tolerate ventilators (e.g., epilepsy);
* Continuous sedation is unlikely to be required during mechanical ventilation (e.g. Guillain-Barre syndrome);
* Patients determined by the clinician to be unlikely to be removed from mechanical ventilation, such as diseases/injuries that primarily affect respirator neuromuscular function and conditions that clearly require long-term ventilation support (such as high spinal cord injury);
* Participation in any other interventional study (any study that assigns subjects to different treatment groups and/or performs unconventional diagnostic or monitoring procedures).

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• Southern medical university Nanfang hospital — Guangzhou, Guangdong, China (RECRUITING)
• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Hongbin HU, doctor

Conditions: Remimazolam Besylate, Sedation, ICU, Remimazolam besylate, Oral cancer