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

NCT ID: NCT03003884

Last Updated: 2017-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-03-31

Brief 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.

Detailed 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.

Conditions

Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Remimazolam Tosilate 1

IV of Remimazolam Tosilate at 5mg for initial dose

Group Type: EXPERIMENTAL

Remimazolam Tosilate

Intervention Type: DRUG

Initial dose plus supplemental doses as necessary.

Remimazolam Tosilate 2

IV of Remimazolam Tosilate at 7mg for initial dose

Group Type: EXPERIMENTAL

Remimazolam Tosilate

Intervention Type: DRUG

Initial dose plus supplemental doses as necessary.

Remimazolam Tosilate 3

IV of Remimazolam Tosilate at 8mg for initial dose

Group Type: EXPERIMENTAL

Remimazolam Tosilate

Intervention Type: DRUG

Initial dose plus supplemental doses as necessary.

Remimazolam Tosilate 4

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

Group Type: EXPERIMENTAL

Remimazolam Tosilate

Intervention Type: DRUG

Initial dose plus supplemental doses as necessary.

Propofol

IV of Propofol at 1.5mg/kg for initial dose

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Initial dose plus supplemental doses as necessary.

Interventions

Remimazolam Tosilate

Initial dose plus supplemental doses as necessary.

Intervention Type: DRUG

Propofol

Initial dose plus supplemental doses as necessary.

Intervention Type: DRUG

Eligibility 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/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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

HR-RMZL-IIc-UGE

Identifier Type: -

Identifier Source: org_study_id