Status:
COMPLETED
Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Sedation
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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.
Detailed Description
This is a multi-center, ,parallel-group, single blind study using Remimazolam or propofol for sedation in patients undergoing diagnostic upper GI endoscopy.Subjects are randomized to different treatme...
Eligibility Criteria
Inclusion
- subjects aged 18-60 years；
- intending to undergo diagnostic upper GI endoscopy;
- ASA( American Society of Anesthesiologists) I or II；
- 18 kg/m²\<BMI(Body Mass Index)\<30 kg/m²;
- the operation time of gastroscopy is not more than 30 min；
- Signed informed consent.
Exclusion
- 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 period；
- 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.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2017
Estimated Enrollment :
378 Patients enrolled
Trial Details
Trial ID
NCT03425474
Start Date
September 1 2017
End Date
November 10 2017
Last Update
February 12 2018
Active Locations (1)
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1
Clinical trial Ethnics Committee of Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 010