MedTrace Logo

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

NCT05606315 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2024-01-09

No results posted yet for this 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.

Conditions

  • Remimazolam Besylate
  • Sedation
  • ICU

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.

Sponsors & Collaborators

  • Peking University Shenzhen Hospital

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-16
Primary Completion
2024-03-31
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05606315 on ClinicalTrials.gov