The study is being conducted to evaluate the efficacy and safety of Remimazolam for intraoperative sedation in pediatric and adolescent patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
138
Remimazolam Tosilate for injection.
Propofol injection.
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGThe overall sedation success rate.
The overall sedation success rate, which encompasses both successful induction of sedation and successful maintenance of adequate sedation throughout the anesthesia procedure.
Time frame: Throughout the anesthesia procedure.
Proportion of subjects with hemodynamic instability.
Defined as a ≥ ±20% change from the baseline in blood pressure or heart rate.
Time frame: Up to 2 days.
Incidence and severity of adverse events during the study.
Time frame: Up to 3 days.
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