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

• Status: Completed
• Trial end date: 2019-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Anesthetics; Propofol

Criteria

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