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

Anesthesia for Elective Surgery Patients Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03921775
• Other study ID #: HR-RMZL-?-GA
• Status: Completed
• Phase: Phase 3
• Start date: May 13, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: May 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclution Criteria:

1. 18~60 years, female or male

2. Patients scheduled for an elective surgical procedure(mechanical ventilation via endotracheal tube)

3. BMI: 18~30 kg/m2

4. Patients understand clearly and participate in the study voluntarily, and sign the informed consent

Exclusion criteria:

1. Patients scheduled for emergency surgery

2. Patients with a history of drug abuse and / or alcohol abuse 2 years prior to the screening period

3. One or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.)

4. Pregnant women or those in lactation period

5. Allergic to drugs used in the study

6. Patients with respiratory management difficulties (Modified Mallampati grade IV)

7. Patients have participated in other clinical trial within the 3 months prior to randomization

8. Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the subject for any other reason

Related Conditions & MeSH terms

• Anesthesia for Elective Surgery Patients

Intervention

Drug:
• Remimazolam Tosilate
For induction and maintenance of general anesthesia
• Propofol
For induction and maintenance of general anesthesia

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage(%) of paticipants who experienced successful anesthesia during operation in each group		Average of 2 hours
Secondary	Time from start of investigational medicinal product administration to loss of consciousness		Average of 2 hours
Secondary	Time from stop of investigational medicinal product to MOAA/S Score=5		Average of 2 hours
Secondary	Time from stop of investigational medicinal product to Aldrete Score>9		Average of 2 hours