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SUSPENDED
NCT05606315
PHASE4

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

Sponsor: Nanfang Hospital, Southern Medical University

View on ClinicalTrials.gov

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.

Official title: RemImazolam Besylate for ICU-sedation in Patients With Mechanical Ventilation After Oral and Maxillofacial Surgery: a Prospective Randomized Non-inferiority Pilot Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

117

Start Date

2022-03-16

Completion Date

2026-12-31

Last Updated

2026-06-10

Healthy Volunteers

No

Interventions

DRUG

Remimazolam Besylate

NS 50ML + Remimazolam besylate(50mg , 2mg:2ml), IV-Pump,maintenance dose 0.5-3mg/kg/h.

DRUG

Propofol

Propofol (50ml, 0.5g), IV-Pump, maintenance dose 0.3-4.0mg/kg/h.

DRUG

Midazolam

Midazolam (10mg,2ml), IV-Pump, maintenance dose 0.02-0.1mg/kg/h.

Locations (2)

Southern medical university Nanfang hospital

Guangzhou, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China