This is a Multi-Center, Randomized, Double-Blind, Propofol-Controlled Phase III Clinical Trial. Around 260 eligible subjects are planned to be enrolled and randomized in a 1:1 ratio to either the HSK3486 arm or propofol arm. The main objective is to evaluate the efficacy of HSK3486 vs. propofol for the induction of sedation/anesthesia in subjects undergoing fiberoptic bronchoscopy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
267
Subjects \< 65 years old:Initial dose of 0.4 mg/kg followed by 0.15 mg/kg if needed;Subjects ≥ 65 years old:75% of the dose for subjects \< 65 years old.
Subjects \< 65 years old:Initial dose of 2 mg/kg followed by 0.75 mg/kg if needed;Subjects ≥ 65 years old:75% of the dose for subjects \< 65 years old.
West China Hospital,Sichuan University
Chengdu, China
Success rate of fiberoptic bronchoscopy. A successful diagnosis/treatment should meet both of the following:
1. Completion of fiberoptic bronchoscopy; 2. No alternative sedation/anesthetic drugs are used, that is, the number of doses of the study drug is ≤ 5 times within any given 15-minute period, starting from the initial administration until the fiberoptic bronchoscopy is completed.
Time frame: During induction of sedation/anesthetic on day 1
Time to successful sedation/anesthetic induction
Time frame: From the initial administration of the investigational drug to the first time when MOAA/S is ≤1 on day 1
Time to fully awake
the time from the withdrawal of the bronchoscope or the last dose of the study drug to the first of 3 consecutive MOAA/S scores = 5
Time frame: From the last dose of study drug or rescue sedative AND from end of fiberoptic bronchoscopy until the patient has recovered to fully alert on day 1
Time to discharge
the time from the withdrawal of the bronchoscope or the last dose of the study drug to the first of 3 consecutive Aldrete scores ≥ 9
Time frame: Time from the last dose of study drug or rescue sedative and from the end of fiberoptic bronchoscopy until discharge (defined as the ability to walk unassisted) on day 1
Use of the investigational drug and alternative drugs
Time frame: During induction of sedation/anesthetic on day 1
Use of questionnaires to estimate sedation/anesthesia satisfaction, including satisfaction assessments of the subject and anesthesiologist
Time frame: During induction of sedation/anesthetic on day 1
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