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

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.

This is an multi-center,single-blinded,parallel-group,dose-finding study using Remimazolam or propofol for sedation in patients undergoing diagnostic upper GI endoscopy.Subjects are randomized to different treatment groups (including 4 for Remimazolam Tosilate and 1 for propofol).Lidocaine and fentanyl are permitted during a diagnostic upper GI endoscopy.Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.

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/m²<BMI(Body Mass Index)<30 kg/m².

Exclusion 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