A Clinical Study of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective Surgery

Phase 3

Completed

• Conditions: Anesthesia for Elective Surgery Patients
• Interventions: Drug: Remimazolam Tosilate; Drug: Propofol

• Registration Number: NCT03921775
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-19
• Study Start: 2019-05-13
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-14
• Last Update Posted: 2020-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A	Remimazolam Tosilate	IV pumping of remimazolam tosilate at 6mg/kg/h for anesthesia induction and 1mg/kg/h for anesthesia maintenance
Treatment B	Propofol	IV pumping of propofol at 120\~150mg/kg/h for anesthesia induction and 3\~12mg/kg/h for anesthesia maintenance

Primary Outcome Measures

Name	Time	Method
Percentage(%) of paticipants who experienced successful anesthesia during operation in each group	Average of 2 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China