Trial Outcomes & Findings for Efficacy and Safety of HSK3486 Compared to Propofol in Induction of General Anesthesia in Adults Having Elective Surgery (NCT NCT04711837)

Last Updated: 2025-10-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

255 participants

Primary outcome timeframe

From start of drug administration to MOAA/S ≤1 (up to 5 minutes)

Results posted on

2025-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	HSK3486 HSK3486 for induction of general anesthesia. HSK3486: HSK3486 for induction of general anesthesia.	Propofol Propofol for induction of general anesthesia. Propofol: Propofol for induction of general anesthesia.
Overall Study STARTED	170	85
Overall Study COMPLETED	168	83
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HSK3486 n=168 Participants HSK3486 for induction of general anesthesia. HSK3486: HSK3486 for induction of general anesthesia.	Propofol n=83 Participants Propofol for induction of general anesthesia. Propofol: Propofol for induction of general anesthesia.	Total n=251 Participants Total of all reporting groups
Age, Customized Age Group (Years) · ≥65	27 Participants n=5 Participants	14 Participants n=7 Participants	41 Participants n=5 Participants
Age, Customized Age Group (Years) · <65	141 Participants n=5 Participants	69 Participants n=7 Participants	210 Participants n=5 Participants
Sex: Female, Male Female	119 Participants n=5 Participants	57 Participants n=7 Participants	176 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	26 Participants n=7 Participants	75 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	45 Participants n=5 Participants	23 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	118 Participants n=5 Participants	58 Participants n=7 Participants	176 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	36 Participants n=5 Participants	12 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) White	121 Participants n=5 Participants	71 Participants n=7 Participants	192 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)

Outcome measures

Outcome measures
Measure	HSK3486 n=168 Participants HSK3486 for induction of general anesthesia. HSK3486: HSK3486 for induction of general anesthesia.	Propofol n=83 Participants Propofol for induction of general anesthesia. Propofol: Propofol for induction of general anesthesia.
Number of Participants With Successful Anesthesia Induction	163 Participants	81 Participants

SECONDARY outcome

Timeframe: Up to 8 hours

Population: Full Analysis Set (FAS): All randomized subjects who have received at least 1 dose of the study drug (HSK3486 or propofol).

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.

Outcome measures

Outcome measures
Measure	HSK3486 n=168 Participants HSK3486 for induction of general anesthesia. HSK3486: HSK3486 for induction of general anesthesia.	Propofol n=83 Participants Propofol for induction of general anesthesia. Propofol: Propofol for induction of general anesthesia.
Subjects' NRS Pain Score Proportion of NRS ≥ 1 pain score on Day 1 · Proportion of NRS ≥4 pain score	10 Participants	51 Participants
Subjects' NRS Pain Score Proportion of NRS ≥ 1 pain score on Day 1 · Proportion of NRS ≥1 and <4 pain score	20 Participants	13 Participants
Subjects' NRS Pain Score Proportion of NRS ≥ 1 pain score on Day 1 · Proportion of NRS = 0 Pain score	137 Participants	19 Participants
Subjects' NRS Pain Score Proportion of NRS ≥ 1 pain score on Day 1 · Missing NRS	1 Participants	0 Participants
Subjects' NRS Pain Score Proportion of NRS ≥ 1 pain Score in PACU · Proportion of NRS ≥1 and <4 pain score	27 Participants	17 Participants
Subjects' NRS Pain Score Proportion of NRS ≥ 1 pain Score in PACU · Proportion of NRS ≥4 pain score	19 Participants	39 Participants
Subjects' NRS Pain Score Proportion of NRS ≥ 1 pain Score in PACU · Proportion of NRS = 0 Pain score	113 Participants	21 Participants
Subjects' NRS Pain Score Proportion of NRS ≥ 1 pain Score in PACU · Missing NRS	9 Participants	6 Participants

SECONDARY outcome

Timeframe: 15 minutes from end of drug administration.

Population: Induction of General Anesthesia

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.

Outcome measures

Outcome measures
Measure	HSK3486 n=168 Participants HSK3486 for induction of general anesthesia. HSK3486: HSK3486 for induction of general anesthesia.	Propofol n=83 Participants Propofol for induction of general anesthesia. Propofol: Propofol for induction of general anesthesia.
Proportion of Subjects With Successful Induction Who Maintain the Desired Depth of Anesthesia for General Elective Surgery, AND Without Significant Cardiac and Respiratory Depression. Successful Induction	163 Participants	81 Participants
Proportion of Subjects With Successful Induction Who Maintain the Desired Depth of Anesthesia for General Elective Surgery, AND Without Significant Cardiac and Respiratory Depression. Failed Induction	5 Participants	2 Participants

SECONDARY outcome

Timeframe: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)

The proportion of subjects with any injection-site pain at time of drug administration on the Numeric Rating Scale (NRS ≥1).

Outcome measures

Outcome measures
Measure	HSK3486 n=167 Participants HSK3486 for induction of general anesthesia. HSK3486: HSK3486 for induction of general anesthesia.	Propofol n=83 Participants Propofol for induction of general anesthesia. Propofol: Propofol for induction of general anesthesia.
Proportion of Subjects With Any Injection-site Pain on Numeric Rating Scale.	30 Participants	64 Participants

SECONDARY outcome

Timeframe: From end of drug administration to MOAA/S ≤1 (up to 5 minutes)

Population: Time to successful induction of general anesthesia was defined as the time from the end of first administration of the study drug to the time when MOAA/S was ≤1.

Time from the end of the first administration of the study drug to MOAA/S ≤1.

Outcome measures

Outcome measures
Measure	HSK3486 n=168 Participants HSK3486 for induction of general anesthesia. HSK3486: HSK3486 for induction of general anesthesia.	Propofol n=83 Participants Propofol for induction of general anesthesia. Propofol: Propofol for induction of general anesthesia.
Time to Successful Induction of General Anesthesia.	0.75 minutes Interval 0.6167 to 0.9	0.62 minutes Interval 0.5167 to 0.8

OTHER_PRE_SPECIFIED outcome

Timeframe: From end of drug administration to disappearance of eyelash reflex (up to 5 minutes)

Population: Time to loss of eyelash reflex was defined as the time from the end of the first administration of the study drug to the time when eyelash reflex was lost.

Time from the end of the first administration of the study drug to the disappearance of eyelash reflex.

Outcome measures

Outcome measures
Measure	HSK3486 n=168 Participants HSK3486 for induction of general anesthesia. HSK3486: HSK3486 for induction of general anesthesia.	Propofol n=83 Participants Propofol for induction of general anesthesia. Propofol: Propofol for induction of general anesthesia.
Time to the Disappearance of Eyelash Reflex	0.92 minutes Interval 0.8333 to 1.0	0.80 minutes Interval 0.7333 to 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)

Failed to meet successful induction of general anesthesia defined by the use of the Top-up Study Drug and Rescue/Remediation Drugs

Outcome measures

Outcome measures
Measure	HSK3486 n=168 Participants HSK3486 for induction of general anesthesia. HSK3486: HSK3486 for induction of general anesthesia.	Propofol n=83 Participants Propofol for induction of general anesthesia. Propofol: Propofol for induction of general anesthesia.
Number of Participants That Failed to Meet Successful Induction of General Anesthesia	5 Participants	2 Participants

Adverse Events

HSK3486

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Propofol

Serious events: 3 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	HSK3486 n=168 participants at risk HSK3486 for induction of general anesthesia. HSK3486: HSK3486 for induction of general anesthesia.	Propofol n=83 participants at risk Propofol for induction of general anesthesia. Propofol: Propofol for induction of general anesthesia.
Cardiac disorders Pulmonary Embolism	0.00% 0/168 • Adverse event reporting begins from the time of informed consent and ends 30 days after the last dose of study drug.	1.2% 1/83 • Number of events 83 • Adverse event reporting begins from the time of informed consent and ends 30 days after the last dose of study drug.
Gastrointestinal disorders Abdominal Wall Haematoma	0.00% 0/168 • Adverse event reporting begins from the time of informed consent and ends 30 days after the last dose of study drug.	1.2% 1/83 • Number of events 83 • Adverse event reporting begins from the time of informed consent and ends 30 days after the last dose of study drug.
Musculoskeletal and connective tissue disorders Femur Fracture	0.00% 0/168 • Adverse event reporting begins from the time of informed consent and ends 30 days after the last dose of study drug.	1.2% 1/83 • Number of events 83 • Adverse event reporting begins from the time of informed consent and ends 30 days after the last dose of study drug.

Other adverse events

Other adverse events
Measure	HSK3486 n=168 participants at risk HSK3486 for induction of general anesthesia. HSK3486: HSK3486 for induction of general anesthesia.	Propofol n=83 participants at risk Propofol for induction of general anesthesia. Propofol: Propofol for induction of general anesthesia.
Vascular disorders Hypotension	28.0% 47/168 • Adverse event reporting begins from the time of informed consent and ends 30 days after the last dose of study drug.	32.5% 27/83 • Adverse event reporting begins from the time of informed consent and ends 30 days after the last dose of study drug.
Gastrointestinal disorders Nausea	27.4% 46/168 • Adverse event reporting begins from the time of informed consent and ends 30 days after the last dose of study drug.	32.5% 27/83 • Adverse event reporting begins from the time of informed consent and ends 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Procedural Pain	19.0% 32/168 • Adverse event reporting begins from the time of informed consent and ends 30 days after the last dose of study drug.	22.9% 19/83 • Adverse event reporting begins from the time of informed consent and ends 30 days after the last dose of study drug.

Additional Information

Yu-Ling Lai Senior Director Clinical Operations

Haisco USA Pharmaceutical Inc.

Phone: 1 732-26-4759

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60