A Multicenter, Randomized, Single-blind, Parallel and Control Phase III Trial Evaluating the Efficacy and Safety of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective Surgery.

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country330 target enrollmentMay 13, 2019

ConditionsAnesthesia for Elective Surgery Patients

InterventionsRemimazolam Tosilate Propofol

DrugsRemimazolam Tosilate Propofol

Overview

Phase: Phase 3
Intervention: Remimazolam Tosilate
Conditions: Anesthesia for Elective Surgery Patients
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 330
Locations: 1
Primary Endpoint: Percentage(%) of paticipants who experienced successful anesthesia during operation in each group
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is being conducted to evaluate the efficacy and safety of remimazolam tosilate compared to propofol for general anesthesia during elective surgery.

Registry

clinicaltrials.gov

Start Date

May 13, 2019

End Date

December 30, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Treatment group A

IV pumping of remimazolam tosilate at 6mg/kg/h for anesthesia induction and 1mg/kg/h for anesthesia maintenance

Intervention: Remimazolam Tosilate

Treatment B

IV pumping of propofol at 120\~150mg/kg/h for anesthesia induction and 3\~12mg/kg/h for anesthesia maintenance

Intervention: Propofol

Outcomes

Primary Outcomes

Percentage(%) of paticipants who experienced successful anesthesia during operation in each group

Time Frame: Average of 2 hours

Secondary Outcomes

Time from stop of investigational medicinal product to MOAA/S Score=5(Average of 2 hours)
Time from start of investigational medicinal product administration to loss of consciousness(Average of 2 hours)
Time from stop of investigational medicinal product to Aldrete Score>9(Average of 2 hours)