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

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05606315

Collaborator

(none)

285

Enrollment

Location

Arms

33.5

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Remimazolam besylate, as a new benzodiazepine drug, has few advantages in respiratory depression and gastrointestinal motility. 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

Condition or Disease	Intervention/Treatment	Phase
Remimazolam Besylate Sedation ICU	Drug: Remimazolam Besylate Drug: Propofol Drug: midazolam	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

285 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

RemImazolam Besylate for ICU-sedation in Patients With Mechanical Ventilation After Oral and Maxillofacial Surgery: a Single-center, Randomized, Non-inferiority Clinical Study

Actual Study Start Date :

Mar 16, 2022

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remimazolam besylate	Drug: Remimazolam Besylate NS 50ML+ Remimazolam besylate(50mg , 2mg:2ml），IV-Pump，maintenance dose 0.1-0.3mg/h
Active Comparator: propofol	Drug: Propofol Propofol (50ml, 0.5g), IV-Pump，maintenance dose 0.3-4.0mg/kg/h
Active Comparator: midazolam	Drug: midazolam midazolam (10mg,2ml), IV-Pump，maintenance dose 0.02-0.1mg/kg/h

Arm

Intervention/Treatment

Experimental: Remimazolam besylate

Drug: Remimazolam Besylate

NS 50ML+ Remimazolam besylate(50mg , 2mg:2ml），IV-Pump，maintenance dose 0.1-0.3mg/h

Active Comparator: propofol

Drug: Propofol

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

Active Comparator: midazolam

Drug: midazolam

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

Outcome Measures

Primary Outcome Measures

Proportion of patients in each group who reached the target analgesia score range [From date of using the intervention drugs until the date of extubation, up to 28 days]]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥18 years old
mechanical ventilation patients with expected ICU stay time <72h
People who need immediate sedative treatment

Exclusion Criteria:

pregnancy；
can not get RASS score from patients
allergy to drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern medical university Nanfang hospital	Guangzhou		China	510515

Sponsors and Collaborators

Nanfang Hospital of Southern Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT05606315

Other Study ID Numbers:

NFEC-2021-341

First Posted:

Nov 4, 2022

Last Update Posted:

Nov 4, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Midazolam

Propofol

Study Results

No Results Posted as of Nov 4, 2022