Sedation
Conditions
Brief summary
The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as a procedural sedative during a diagnostic upper GI endoscopy and to assess its efficacy and safety profile comparing to propofol.
Detailed description
This is an multi-center,single-blinded,parallel-group,dose-finding study using Remimazolam or propofol for sedation in patients undergoing diagnostic upper GI endoscopy.Subjects are randomized to different treatment groups (including 4 for Remimazolam Tosilate and 1 for propofol).Lidocaine and 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 * American Society of Anesthesiologists Physical Status Score (ASA PS) I or II； * 18 kg/m²\<BMI(Body Mass Index)\<30 kg/m².
Exclusion criteria
* Patients with a suspected upper GI bleed an conditions predisposing to hemorrhage at the discretion of the investigator; * one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.); * history of recent use of narcotics,analgesics,anaesthetics and benzodiazepine hypnotics; * history of severe cardiovascular disease; * cerebral disease or mental disorder; * allergic to drugs used in the study; * pregnant women or those in lactation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy. | From start of study drug injection to patient discharge (approx. 3 hours) |
Secondary
| Measure | Time frame |
|---|---|
| recovery time as measured by time | After the last of study drug injection to patient discharge (approx. 3 hours) |
| rate of hypotension as measured by the proportion of subjects who experienced hypotension during a diagnostic upper GI endoscopy | From start of study drug injection to patient discharge (approx. 3 hours) |
| rate of hypoxaemia as measured by the proportion of subjects who experienced hypoxaemia during a diagnostic upper GI endoscopy | From start of study drug injection to patient discharge (approx. 3 hours) |
| rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression during a diagnostic upper GI endoscopy | From start of study drug injection to patient discharge (approx. 3 hours) |
| pain on injection was assessed by the patient immediately after administration of the study drug | 1-10 minutes (from the beginning of sedation )] |
Countries
China
Outcome results
None listed