A Phase III Clinical Study Evaluating the Efficacy and Safety of Remimazolam Tosilate Compared to Propofol in Patients Undergoing Bronchoscopy

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country330 target enrollmentJune 15, 2020

ConditionsSedation

InterventionsRemimazolam Tosilate Propofol

DrugsRemimazolam Tosilate Propofol

Overview

Phase: Phase 3
Intervention: Remimazolam Tosilate
Conditions: Sedation
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 330
Locations: 1
Primary Endpoint: Percentage (%) of participants who experienced successful sedation in undergoing bronchoscopy in each group
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A multicenter, randomized, single-blind, active controlled, parallel group study comparing remimazolam tosilate to propofol in patients undergoing bronchoscopy.

Registry

clinicaltrials.gov

Start Date

June 15, 2020

End Date

October 30, 2020

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18\~80 years, female or male
•Patients scheduled for an bronchoscopy procedure
•18 kg/m2\<BMI\<30kg/m2
•Patients understand clearly and participate in the study voluntarily, and sign the informed consent

Exclusion Criteria

•Patients scheduled for emergency surgery
•Patients with a history of drug abuse and / or alcohol abuse 2 years prior to the screening period
•One or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
•Pregnant women or those in lactation period
•Allergic to drugs used in the study
•Patients have participated in other clinical trial within the 3 months prior to randomization
•Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the subject for any other reason

Arms & Interventions

Remimazolam Tosilate

Intervention: Remimazolam Tosilate

Propofol

Intervention: Propofol

Outcomes

Primary Outcomes

Percentage (%) of participants who experienced successful sedation in undergoing bronchoscopy in each group

Time Frame: From the onset of administration of the study drug to removal of bronchoscope on Day 1 of treatment

Secondary Outcomes

Time from start of investigational medicinal product administration to loss of consciousness(From the onset of administration of the study drug to unconsciousness on Day 1 of treatment)
Time from stop of investigational medicinal product to MOAA/S Score=5(From the last dose of study drug until the patient has recovered to fully alert on Day 1 of treatment)
Time from stop of investigational medicinal product to Aldrete Score≥9(From the end of administration of the study drug until the patient reaches the modified Aldrete's system score of ≥9 points on Day 1 of treatment)