This is a Phase II, dose-escalation clinical trial conducted in mechanically ventilated patients receiving sedation no longer than 24 hours. The efficacy, safety, and pharmacokinetics of remimazolam besylate were evaluated using a randomized, single-blind design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
36
After a loading dose of 0.08mg/kg, a maintaining dose of 0.1mg/kg/h is given
After a loading dose of 0.08mg/kg, a maintaining dose of 0.2mg/kg/h is given
After a loading dose of 0.08mg/kg, a maintaining dose of 0.4mg/kg/h is given
Wuhan Union Hospital
Wuhan, Hubei, China
The percentage of time in the target sedation range without rescue sedation
The percentage of time in the target sedation range without rescue sedation
Time frame: Within 24 hours while receiving the study drug
The number and severity of treatment emergent adverse events (TEAEs)
The number and severity of treatment emergent adverse events (TEAEs)
Time frame: Within 48 hours after the stop of the study drug
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