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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 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
• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam Tosilate 1; IV of Remimazolam Tosilate at 5mg for initial dose	Drug: Remimazolam Tosilate; Initial dose plus supplemental doses as necessary.
Experimental: Remimazolam Tosilate 2; IV of Remimazolam Tosilate at 7mg for initial dose	Drug: Remimazolam Tosilate; Initial dose plus supplemental doses as necessary.
Experimental: Remimazolam Tosilate 3; IV of Remimazolam Tosilate at 8mg for initial dose	Drug: Remimazolam Tosilate; Initial dose plus supplemental doses as necessary.
Experimental: Remimazolam Tosilate 4; IV of Remimazolam Tosilate at 5mg for initial dose.At the end of the endoscopy, flumazenil was injected.	Drug: Remimazolam Tosilate; Initial dose plus supplemental doses as necessary.
Active Comparator: Propofol; IV of 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	Time Frame
successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy.	From start of study drug injection to patient discharge (approx. 3 hours)

Secondary Outcome Measures

Outcome Measure	Time Frame
recovery time as measured by time	After the last of study drug injection to patient discharge (approx. 3 hours)
rate of hypotension as measured by the proportion of subjects who experienced hypotension during a diagnostic upper GI endoscopy	From start of study drug injection to patient discharge (approx. 3 hours)
rate of hypoxaemia as measured by the proportion of subjects who experienced hypoxaemia during a diagnostic upper GI endoscopy	From start of study drug injection to patient discharge (approx. 3 hours)
rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression during a diagnostic upper GI endoscopy	From start of study drug injection to patient discharge (approx. 3 hours)
pain on injection was assessed by the patient immediately after administration of the study drug	1-10 minutes (from the beginning of sedation )]

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: December 27, 2016
• First Posted (Estimate): December 28, 2016

Study Record Updates

• Last Update Posted (Actual): September 8, 2017
• Last Update Submitted That Met QC Criteria: September 6, 2017
• Last Verified: December 1, 2016

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-IIc-UGE