Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy

Hengrui Medicine

Status and phase

Completed

Phase 3

Conditions

Sedation

Treatments

Drug: Propofol

Drug: Remimazolam Tosilate

Study type

Interventional

Funder types

Industry

Identifiers

NCT03425474

HR-RMZL-Ⅲ-UGE

Details and patient eligibility

About

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.

Full description

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

Enrollment

378 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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<BMI(Body Mass Index)<30 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.