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

Phase 2

Completed

• Conditions: Sedation
• Interventions: Drug: Remimazolam Tosilate; Drug: Propofol

• Registration Number: NCT03003884
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Study Timeline

• Study Start: 2016-11
• Status Verified: 2016-12
• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2016-12-27
• Study First Posted: 2016-12-28
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-09-06
• Last Update Posted: 2017-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam Tosilate 2	Remimazolam Tosilate	IV of Remimazolam Tosilate at 7mg for initial dose
Remimazolam Tosilate 3	Remimazolam Tosilate	IV of Remimazolam Tosilate at 8mg for initial dose
Remimazolam Tosilate 4	Remimazolam Tosilate	IV of Remimazolam Tosilate at 5mg for initial dose.At the end of the endoscopy, flumazenil was injected.
Remimazolam Tosilate 1	Remimazolam Tosilate	IV of Remimazolam Tosilate at 5mg for initial dose
Propofol	Propofol	IV of Propofol at 1.5mg/kg for initial dose

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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)
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)
pain on injection was assessed by the patient immediately after administration of the study drug	1-10 minutes (from the beginning of sedation )]
recovery time as measured by time	After the last of study drug injection to patient discharge (approx. 3 hours)

Trial Locations

Locations (1)

Beijing Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China