A multicenter, randomized, single-blind, active controlled, parallel group study comparing remimazolam tosilate to propofol in patients undergoing bronchoscopy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
330
Intravenous injection at a dose of 0.3mg/kg for sedation induction and continuous intravenous infusion at an initiative dose of 1 mg/kg/h for sedation maintenance.
Intravenous injection at a dose of 1.5\~2.5mg/kg for sedation induction and continuous intravenous infusion at the dose of 0\~12 mg/kg/h for sedation maintenance
Peking Union Medical College Hospital
Beijing, China
Percentage (%) of participants who experienced successful sedation in undergoing bronchoscopy in each group
Time frame: From the onset of administration of the study drug to removal of bronchoscope on Day 1 of treatment
Time from start of investigational medicinal product administration to loss of consciousness
Time frame: From the onset of administration of the study drug to unconsciousness on Day 1 of treatment
Time from stop of investigational medicinal product to MOAA/S Score=5
Time frame: From the last dose of study drug until the patient has recovered to fully alert on Day 1 of treatment
Time from stop of investigational medicinal product to Aldrete Score≥9
Time frame: From the end of administration of the study drug until the patient reaches the modified Aldrete's system score of ≥9 points on Day 1 of treatment
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