Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy

A Phase Ⅲ, Multicentre, Randomized, Single-blinded Study to Evaluate the Safety and Efficacy of the Sedation for Remimazolam or Propofol in Patients Undergoing Diagnostic Upper GI Endoscopy

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.

Study Overview

• Status: Completed
• Conditions: Sedation
• Intervention / Treatment: Drug: Remimazolam Tosilate; Drug: Propofol

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 378
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 010
      • Clinical trial Ethnics Committee of Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam Tosilate; Remimazolam Tosilate at 5mg for initial dose	Drug: Remimazolam Tosilate; Initial dose plus supplemental doses as necessary
Active Comparator: Propofol; Propofol at 1.5mg/kg for initial dose	Drug: Propofol; Initial dose plus supplemental doses as necessary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of successful sedation	successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy.	approximately 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation induction time	Sedation induction time is defined as from start of study drug injection to the first time of MOAA/S（The Observer's Assessment of Alertness/Sedation Scale） ≤ 3.	approximately 3 hours
Sedation recovery time	Sedation induction time is defined as from stop of study drug injection to be wide awake.	approximately 3 hours
rate of hypotension	rate of hypotension as measured by the proportion of subjects who experienced hypotension during a diagnostic upper GI endoscopy	approximately 3 hours
rate of respiratory depression	rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression during a diagnostic upper GI endoscopy	approximately 3 hours

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): November 10, 2017
• Study Completion (Actual): November 10, 2017

Study Registration Dates

• First Submitted: September 16, 2017
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: HR-RMZL-Ⅲ-UGE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No