To evaluate the efficacy and safety of Remimazolam Tosilate for injection in local anesthesia assisted sedation, and to explore the dose range of remazolam toluenesulfonate for injection in local anesthesia assisted sedation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
Treatment group A: Remimazolam Tosilate; high dose Treatment group B: Remimazolam Tosilate; low dose
Treatment group C: Propofol Injection.
West China Hospital
Chengdu, Sichuan, China
The time to maintain target sedation as a percentage of the total study administration time.
Time frame: through study completion,an average of about 1 hour
Proportion of subjects who achieved target sedation within 3 minutes after starting intravenous injection of load dose test drugs;
Time frame: 3 minutes after administration
Proportion of subjects receiving remedial sedation;
Time frame: through study completion,an average of about 1 hour
The time from the start of intravenous injection of load dose test drug to the first achievement of target sedation;
Time frame: Time to achieve target sedation, an average of about 4 minutes
The time from stopping infusion of test drugs to reaching MOAA/S level 5 for the first time after operation
Time frame: Recovery time, an average of about 7 minutes
Anesthesiologists' satisfaction with sedation
Time frame: through study completion,an average of about 1 hour
Evaluation of subjects' satisfaction with sedation treatment;
Time frame: through study completion,an average of about 1 hour
Incidence of anterograde amnesia.
Time frame: through study completion,an average of about 1 hour
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