This is a multicenter, randomized, double-blinded, propofol-controlled, Phase 3 clinical study to evaluate the efficacy and safety of HSK3486 for induction of general anesthesia in adults undergoing elective surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
255
Arizona Research Center
Phoenix, Arizona, United States
Lotus Clinical Research, LLC
Pasadena, California, United States
Phoenix Clinical Research, LLC
Tamarac, Florida, United States
Number of Participants With Successful Anesthesia Induction
The primary outcome of interest was the success rate of anesthesia induction, defined by the proportion of subjects with successful anesthesia. A subject was considered successful for anesthetic induction if the following conditions were met: induction success Modified Observer's Assessment of Awareness/Sedation Scale (MOAA/S ≤1) after administration of study drug and 1 or less top-up dose required without using any rescue drugs. Where Grade 0 is no response after trapezius squeeze, Grade 1 responds only after painful trapezius squeeze and Grade 5 is completely awake responds to name spoken in normal tone.
Time frame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)
Subjects' NRS Pain Score
Injection-site pain is evaluated verbally during study drug administration using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worse imaginable pain). Subjects' NRS pain score at the time of study drug administration (Day 1) and recall of pain score in PACU.
Time frame: Up to 8 hours
Proportion of Subjects With Successful Induction Who Maintain the Desired Depth of Anesthesia for General Elective Surgery, AND Without Significant Cardiac and Respiratory Depression.
The proportion of subjects with successful induction who maintain the desired depth of anesthesia for general elective surgery, AND without significant cardiac and respiratory depression between the time of successful induction and 15 minutes post initiation of study drug administration, or up to the beginning of second tracheal intubation attempt if it is a difficult condition and not beyond 15 minutes post initiation of study drug administration.
Time frame: 15 minutes from end of drug administration.
Proportion of Subjects With Any Injection-site Pain on Numeric Rating Scale.
The proportion of subjects with any injection-site pain at time of drug administration on the Numeric Rating Scale (NRS ≥1).
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The University of Chicago Medicine
Chicago, Illinois, United States
New York City Heath and Hospitals
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
UNC Health Care System
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
The Ohio State University Research Foundation
Columbus, Ohio, United States
HD Research
Bellaire, Texas, United States
...and 3 more locations
Time frame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)
Time to Successful Induction of General Anesthesia.
Time from the end of the first administration of the study drug to MOAA/S ≤1.
Time frame: From end of drug administration to MOAA/S ≤1 (up to 5 minutes)