Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy

• Status: Completed
• Trial end date: 2017-11-10
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of the sedation for Remimazolam or Propofol in patients undergoing diagnostic upper GI endoscopy.

• Phase: Phase 3
• 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;

• ASA( American Society of Anesthesiologists) I or II；

• 18 kg/m²- the operation time of gastroscopy is not more than 30 min；

• Signed informed consent.

Exclusion Criteria:

• Patients need to be Complicated gastroscopy;

• Patients need to be Tracheal intubation;

• Patients with respiratory management difficulties (Modified Mallampati grade IV）;

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

• A history of drug abuse and / or alcohol abuse 2 years prior to the screening period；

• allergic to drugs used in the study;

• pregnant women or those in lactation period

• The subject has participated in other clinical trial within the 3 months prior to randomization.