Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy (NCT03425474) | Clinical Trial Compass
CompletedPhase 3
Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy
China378 participantsStarted 2017-09-01
Plain-language summary
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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* subjects aged 18-60 yearsï¼›
* intending to undergo diagnostic upper GI endoscopy;
* ASA( American Society of Anesthesiologists) I or IIï¼›
* 18 kg/m²\<BMI(Body Mass Index)\<30 kg/m²;
* the operation time of gastroscopy is not more than 30 minï¼›
* 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 periodï¼›
* 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.