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

Jiangsu HengRui Medicine Co., Ltd.153 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

153

Conditions

Sedation

Interventions

Remimazolam TosilateDRUG

Initial dose plus supplemental doses as necessary.

PropofolDRUG

Initial dose plus supplemental doses as necessary.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Union Medical College Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy.

Time frame: From start of study drug injection to patient discharge (approx. 3 hours)

Secondary Outcomes

recovery time as measured by time

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 1-10 minutes (from the beginning of sedation )]

Data from ClinicalTrials.gov

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