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

Outcome

Outcome not reported

Stopped (Enrollment): “The trial was terminated early because additional sites did not recruit as planned, making the multicenter sample size infeasible. Enrollment ended after 117 participants were randomized at Nanfang Hospital, unrelated to safety, efficacy, or outcomes”

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.