CompletedPhase 2

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

China153 participantsStarted 2016-11

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

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

Trial details

NCT IDNCT03003884

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-03

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