This is a Phase III, randomized, double-blind, propofol-controlled, parallel-design, multi-center study to evaluate the efficacy and safety of HSK3486 for sedation or anesthesia in patients undergoing colonoscopy and gastroscopy. The study will enroll approximately 280 adults. The maximum study duration is anticipated to be up to nine months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
280
West China Hospital, Sichuan University
Changde, China
Success of colonoscopy procedure
Measured by completion of colonoscopy, no requirement for an alternative sedative or anesthesia drug and no requirement for more than 5 doses of study drug within any 15 minute period.
Time frame: from the first dose of the study drug to removal of colonoscope on day 1
The success rate of the gastroscopy procedure
Time frame: from the first dose of the study drug to removal of gastroscope on day 1
The success rate of the colonoscopy and gastroscopy procedure
Time frame: from the first dose of the study drug to rem oval of colonoscope and gastroscope on day 1
Time to induction of sedation or anaesthesia
Time frame: from the first dose of the study drug to the first MOAA/S scores≤1 on day 1
Time to start of procedure
Time frame: From first dose of study drug until insertion of colonoscope or gastroscope on day 1
Time to fully alert
Time frame: from the removal of colonoscopy or gastroscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1
Time to discharge
Time frame: from the removal of colonoscopy or gastroscopy procedure, until the first of three consecutive Aldrete scores of more than or equal to 9 on day 1
Sedation/anesthesia satisfaction, satisfaction assessment of subjects, anesthesiologists, and endoscopic physicians
Time frame: from time to fully alert, until time to discharge on day 1
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