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

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: Sedation

Treatments: Drug: Remimazolam Tosilate; Drug: Propofol

Study type: Interventional

Funder types: Industry

Identifiers

NCT03003884

HR-RMZL-IIc-UGE

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 153 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
• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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153 participants in 5 patient groups

Remimazolam Tosilate 1

Experimental group

Description:

IV of Remimazolam Tosilate at 5mg for initial dose

Treatment:

Drug: Remimazolam Tosilate

Remimazolam Tosilate 2

Experimental group

Description:

IV of Remimazolam Tosilate at 7mg for initial dose

Treatment:

Drug: Remimazolam Tosilate

Remimazolam Tosilate 3

Experimental group

Description:

IV of Remimazolam Tosilate at 8mg for initial dose

Treatment:

Drug: Remimazolam Tosilate

Remimazolam Tosilate 4

Experimental group

Description:

IV of Remimazolam Tosilate at 5mg for initial dose.At the end of the endoscopy, flumazenil was injected.

Treatment:

Drug: Remimazolam Tosilate

Propofol

Active Comparator group

Description:

IV of Propofol at 1.5mg/kg for initial dose

Treatment:

Drug: Propofol