Sedation
Conditions
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 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.
Interventions
Initial dose plus supplemental doses as necessary
DRUGPropofol
Initial dose plus supplemental doses as necessary
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of successful sedation | approximately 3 hours | successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation induction time | 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. |
| Sedation recovery time | approximately 3 hours | Sedation induction time is defined as from stop of study drug injection to be wide awake. |
| rate of hypotension | approximately 3 hours | rate of hypotension as measured by the proportion of subjects who experienced hypotension during a diagnostic upper GI endoscopy |
| rate of respiratory depression | approximately 3 hours | rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression during a diagnostic upper GI endoscopy |
Countries
China
Outcome results
None listed