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.
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 treatment groups (including 1 for Remimazolam Tosilate and 1 for propofol). 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
378
Initial dose plus supplemental doses as necessary
Initial dose plus supplemental doses as necessary
Clinical trial Ethnics Committee of Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
rate of successful sedation
successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy.
Time frame: approximately 3 hours
Sedation induction time
Sedation induction time is defined as from start of study drug injection to the first time of MOAA/S（The Observer's Assessment of Alertness/Sedation Scale） ≤ 3.
Time frame: approximately 3 hours
Sedation recovery time
Sedation induction time is defined as from stop of study drug injection to be wide awake.
Time frame: approximately 3 hours
rate of hypotension
rate of hypotension as measured by the proportion of subjects who experienced hypotension during a diagnostic upper GI endoscopy
Time frame: approximately 3 hours
rate of respiratory depression
rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression during a diagnostic upper GI endoscopy
Time frame: approximately 3 hours
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