Clinical trial Ethnics Committee of Peking Union Medical College Hospital
Beijing, Beijing Municipality, 010, China
NCT Number: NCT03425474
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 3
Beijing, Beijing Municipality, 010, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Initial dose plus supplemental doses as necessary
Initial dose plus supplemental doses as necessary
Time frame: approximately 3 hours
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 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 induction time is defined as from stop of study drug injection to be wide awake.
Time frame: approximately 3 hours
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 as measured by the proportion of subjects who experienced respiratory depression during a diagnostic upper GI endoscopy
Jiangsu HengRui Medicine Co., Ltd.
Industry
A Phase Ⅲ, Multicentre, Randomized, Single-blinded Study to Evaluate the Safety and Efficacy of the Sedation for Remimazolam or Propofol in Patients Undergoing Diagnostic Upper GI Endoscopy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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