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

Phase 4 Terminated 117 enrolled Nanfang Hospital, Southern Medical University Peking University Shenzhen Hospital · collab

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start: 2022-03-16
Primary completion: 2025-01-12
Completion: 2025-02-09

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Midazolam	Small molecule	0.02 mg/kg	Intravenous
Comparator	Midazolam	Small molecule	0.1 mg/kg	Intravenous
Comparator	Propofol	Small molecule	0.3 mg/kg	Intravenous
Comparator	Propofol	Small molecule	4 mg/kg	Intravenous
Subject	Remimazolam	Small molecule	0.5 mg/kg	Intravenous
Subject	Remimazolam	Small molecule	3 mg/kg	Intravenous

Indications

No indication recorded.