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

Last updated: January 7, 2024
Sponsor: Nanfang Hospital, Southern Medical University
Overall Status: Active - Recruiting

Phase

4

Condition

Anesthesia

Treatment

Midazolam

Remimazolam Besylate

Propofol

Clinical Study ID

NCT05606315
NFEC-2021-341
  • Ages > 18
  • All Genders

Study Summary

Remimazolam besylate, as a new benzodiazepine drug, showing rapid clearance and moderate distribution of pharmacokinetic changes. The study will further explore the safety and effectiveness of remimazolam besylate n the sedation of mechanically ventilated patients after oral and maxillofacial surgery in the ICU.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years old;
  • After undergoing oral and maxillofacial surgery, it is expected that a ventilator willbe 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

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 withMAP<50 mmHg despite adequate fluid resuscitation and vasopressor therapy);
  • Severe bradycardia (heart rate <50 beats/min) or degree II-III heart block (unless apacemaker 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 mechanicalventilation, such as diseases/injuries that primarily affect respirator neuromuscularfunction and conditions that clearly require long-term ventilation support (such ashigh spinal cord injury);
  • Participation in any other interventional study (any study that assigns subjects todifferent treatment groups and/or performs unconventional diagnostic or monitoringprocedures).

Study Design

Total Participants: 285
Treatment Group(s): 3
Primary Treatment: Midazolam
Phase: 4
Study Start date:
March 16, 2022
Estimated Completion Date:
December 31, 2024

Study Description

Remimazolam besylate is a new type of ultra-short-acting benzodiazepine, showing rapid clearance and moderate distribution of pharmacokinetic changes. Remimazolam has been widely studied for programmed sedation in endoscopic procedures such as gastroenteroscopy and bronchoscopy. Remimazolam, as a short-acting sedative agent that is not metabolized by liver or kidney, can achieve rapid and reversible sedation and has the potential to shorten the duration of mechanical ventilation.

In the oral and maxillofacial surgical treatment, the use of microvascular free tissue transfer for reconstruction is one of the common operations. In order to avoid mechanical damage to the transplanted reconstructed tissue due to spontaneous movement, patients undergoing major head and neck reconstruction surgery are considered to require postoperative deep sedation for a certain period of time (RASS score required -4/-5 points). Deep sedation may cause hypotension and lead to reduced flap perfusion pressure, increasing the risk of hypoperfusion and flap necrosis, thus requiring close postoperative monitoring in the ICU.

Therefore, there is an urgent need for a sedative drug that can achieve rapid and sufficient sedation, does not inhibit breathing and can reduce the amount of patients or rapid recovery after drug withdrawal without increasing delirium. Based on the deficiencies of currently used sedatives and the potential advantages of remimazolam, we hypothesize that remimazolam can shorten the extubation time and lower the adverse reaction rate in patients with oropharyngeal cancer after mechanical ventilation sedation.

This clinical study was a randomized, multi-center, parallel-controlled, non-inferior clinical study. After signing the informed consent, participants meeting the inclusion/exclusion criteria will be randomly assigned to the treatment group (ramazolam besylate) and the control group (propofol, midazolam) in a ratio of 1:1:1, with a total of 285 participants recruited.

Connect with a study center

  • Southern medical university Nanfang hospital

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong 518036
    China

    Site Not Available

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