A Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as a procedural sedative during a diagnostic upper GI endoscopy and to assess its efficacy and safety profile comparing to propofol.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• subjects aged 18-60 years；

• intending to undergo diagnostic upper GI endoscopy

• American Society of Anesthesiologists Physical Status Score (ASA PS) I or II；

• 18 kg/m²Exclusion Criteria:

• Patients with a suspected upper GI bleed an conditions predisposing to hemorrhage at the discretion of the investigator;

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

• history of recent use of narcotics,analgesics,anaesthetics and benzodiazepine hypnotics;

• history of severe cardiovascular disease;

• cerebral disease or mental disorder;

• allergic to drugs used in the study;

• pregnant women or those in lactation period