The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in non-intubated diagnostic and therapeutic procedures
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
Initial loading dose of 5mg, with additional doses of 2.5mg as necessary
Initial loading dose of 10mg, with additional doses of 2.5mg as necessary
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Rate of sedation success, Sedation success
Rate of sedation success, Sedation success is defined as: 1) Completion of the entire non-intubated diagnostic and therapeutic procedure; 2) No need for additional rescue sedation; 3) During the sedation induction phase, the MOAA/S score should be ≤3 within 2 minutes after the end of the initial dose administration or after ≤2 additional administrations; 4) No more than 2 additional administrations in every 5-minute.
Time frame: day 1
Number of additional administrations.
Time frame: day 1
Percentage of subjects needing additional administration.
Time frame: day 1
One-time success rate of endoscope insertion during the diagnostic and therapeutic procedure.
Time frame: day 1
Rate of over-sedation.
Time frame: day 1
Sedation induction time
Time frame: day 1
Wake-up time.
Time frame: day 1
Time to discharge.
Time frame: day 1
Rate of sedation-related hypotension and rate of sedation-related hypotension needing treatment.
Time frame: day 1
Rate of respiratory depression during sedation.
Time frame: day 1
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Investigator's Satisfaction with Sedation Assessment: The scoring range is from 0 to 10, where 0 represents dissatisfaction and 10 represents complete satisfaction.
Time frame: day 1
Participant's satisfaction with Sedation Assessment: The scoring range is from 0 to 10, where 0 represents dissatisfaction and 10 represents complete satisfaction.
Time frame: day 1