RemImazolam Besylate for ICU-sedation in Patients With Mechanical Ventilation After Oral and Maxillofacial Surgery

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Nov 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called remimazolam besylate, which is designed to help sedate patients who are on mechanical ventilation after having surgery on their mouth or face. The goal is to see how safe and effective this medication is for patients in the intensive care unit (ICU) who need help breathing for a short time, typically less than three days. By exploring how quickly the drug works and how well it helps with sedation, the researchers hope to improve care for these patients.

To participate in this trial, people must be at least 18 years old and need assistance with breathing after their surgery. They should expect to stay in the ICU for a short period and require immediate sedation. However, some individuals may not be eligible, such as those who are pregnant, have certain severe health conditions, or have a history of using specific medications. If someone qualifies and agrees to take part, they will receive the medication while being closely monitored by medical staff to ensure their safety and comfort.

Gender

ALL

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).