Efficacy and Safety of HSK3486 Compared to Propofol in Induction of General Anesthesia in Adults Having Elective Surgery

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-blinded, Propofol-controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HSK3486 Injectable Emulsion for Induction of General Anesthesia in Adults Undergoing Elective Surgery.

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: HSK3486
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HSK3486<br>HSK3486 for induction of general anesthesia. | Drug: HSK3486<br>* HSK3486 for induction of general anesthesia.<br>|
| Active Comparator: Propofol<br>Propofol for induction of general anesthesia. | Drug: Propofol<br>* Propofol for induction of general anesthesia.<br>* Other names: Diprivan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From start of drug administration to MOAA/S ≤1 (up to 5 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 5 minutes | 
| 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. | 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). | 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. | From start of drug administration to MOAA/S ≤1 (up to 5 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Elective surgery, Propofol