Phase 3
N=255
Efficacy and Safety of HSK3486 Compared to Propofol in Induction of General Anesthesia in Adults Having Elective Surgery
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT04711837 ↗Enrolled (actual)
255
Serious AEs
1.2%
Results posted
May 2023
Primary outcome: Primary: Number of Participants With Successful Anesthesia Induction — 163; 81 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- HSK3486 (Drug); Propofol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Haisco-USA Pharmaceuticals, Inc.
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Anesthesia Induction |
163; 81 | — |
| SECONDARY Subjects' NRS Pain Score |
20; 13; 10; 51; 137; 19 | — |
| SECONDARY Proportion of Subjects With Successful Induction Who Maintain the Desired Depth of Anesthesia for General Elective Surgery, AND Without Significant Cardiac and Respiratory Depression. |
163; 81; 5; 2 | — |
| SECONDARY Proportion of Subjects With Any Injection-site Pain on Numeric Rating Scale. |
30; 64 | — |
| SECONDARY Time to Successful Induction of General Anesthesia. |
0.75; 0.62 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Subjects undergoing elective surgery (nonemergency, noncardiothoracic, and nonintracranial surgery anticipated to last at least 1 hour ).
- Males or females, aged ≥18 years old, with American Society of Anesthesiologists Physical Status (ASA PS) I to IV.
- Body mass index (BMI) ≥18 kg/m2.
- For all females of childbearing potential, negative pregnancy test at screening and baseline. Additionally, females of childbearing potential must agree to use birth control (such as condom, intrauterine device [IUD], abstinence) from the time of consent until 30 days post study drug administration.
- Capable of understanding the procedures and methods of this study, willing to sign an Informed Consent Form, and to complete this study in strict compliance with the study protocol.
Exclusion Criteria
- Contraindications to deep sedation/general anesthesia or a history of adverse reaction to sedation/general anesthesia.
- Known to be allergic to eggs, soy products, opioids and their antidotes, or propofol; subject having contraindications to propofol, opioids, and their antidotes.
- Medical condition or evidence of increased sedation/general anesthesia risk.
- Management risks of respiratory tract and judged by the investigator to be unsuitable for inclusion in the study.
- Any medication that has the potential to interact synergistically with propofol or HSK3486, including but not limited to all sedatives and hypnotics.
- Laboratory parameters significantly out of range at screening.
- Female subjects with a positive pregnancy test (serum or urine) at screening or baseline; lactating subjects; any subject planning to get pregnant within 1 month after the study (including the male subject's partner).
- Judged by the investigator to have any other factors that make the subject unsuitable for participation in the study.
Data sourced from ClinicalTrials.gov (NCT04711837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.