Trial Outcomes & Findings for Efficacy and Safety of HSK3486 Compared to Propofol for Adults Undergoing Elective Surgery With General Anesthesia (NCT NCT05478174)

NCT ID: NCT05478174

Last Updated: 2025-10-10

Results Overview

1. Induction success (MOAA/S ≤1) after administration of the study drug, and 2. One or less top-up doses required without using any rescue drugs.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 400 participants
• Primary outcome timeframe: From the time of study drug administration to desired depth of anesthesia to MOAA/S≤1 ( up to 5 minutes)
• Results posted on: 2025-10-10

Participant Flow

Participant milestones

Measure	HSK3486 HSK3486 for general anesthesia induction HSK3486: HSK3486 for induction of general anesthesia	Propofol Propofol for general anesthesia induction Propofol: Propofol for induction of general anesthesia.
Overall Study STARTED	267	133
Overall Study Dosed	255	129
Overall Study Full Analysis Set	255	128
Overall Study Safety Set	255	129
Overall Study COMPLETED	254	129
Overall Study NOT COMPLETED	13	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of HSK3486 Compared to Propofol for Adults Undergoing Elective Surgery With General Anesthesia

Baseline characteristics by cohort

Measure	HSK3486 n=255 Participants HSK3486 for general anesthesia induction HSK3486: HSK3486 for induction of general anesthesia	Propofol n=128 Participants Propofol for general anesthesia induction Propofol: Propofol for induction of general anesthesia.	Total n=383 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	192 Participants n=5 Participants	97 Participants n=7 Participants	289 Participants n=5 Participants
Age, Categorical >=65 years	63 Participants n=5 Participants	31 Participants n=7 Participants	94 Participants n=5 Participants
Sex: Female, Male Female	153 Participants n=5 Participants	84 Participants n=7 Participants	237 Participants n=5 Participants
Sex: Female, Male Male	102 Participants n=5 Participants	44 Participants n=7 Participants	146 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=5 Participants	16 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	220 Participants n=5 Participants	110 Participants n=7 Participants	330 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 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	7 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	41 Participants n=5 Participants	20 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) White	203 Participants n=5 Participants	102 Participants n=7 Participants	305 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
ASA-PS ASA-PS I	62 Participants n=5 Participants	27 Participants n=7 Participants	89 Participants n=5 Participants
ASA-PS ASA-PS II	135 Participants n=5 Participants	74 Participants n=7 Participants	209 Participants n=5 Participants
ASA-PS ASA-PS III	58 Participants n=5 Participants	27 Participants n=7 Participants	85 Participants n=5 Participants
BMI <35kg/m^2	204 Participants n=5 Participants	102 Participants n=7 Participants	306 Participants n=5 Participants
BMI ≥35kg/m^2	51 Participants n=5 Participants	26 Participants n=7 Participants	77 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the time of study drug administration to desired depth of anesthesia to MOAA/S≤1 ( up to 5 minutes)

1. Induction success (MOAA/S ≤1) after administration of the study drug, and

2. One or less top-up doses required without using any rescue drugs.

Outcome measures

Measure	HSK3486 n=255 Participants HSK3486 for general anesthesia induction HSK3486: HSK3486 for induction of general anesthesia	Propofol n=128 Participants Propofol for general anesthesia induction Propofol: Propofol for induction of general anesthesia.
Success Rate of General Anesthesia Induction	253 Participants	128 Participants

SECONDARY outcome

Timeframe: 15 minutes from end of drug administration

The outcome is defined by all the following conditions:

a) Desired depth of anesthesia for general elective surgery is defined if all following criteria are met: i) No clinical signs of inadequate depth of anesthesia, such as lacrimation, movement, vomiting, coughing, laryngospasm, bucking, swallowing reflex or bronchospasm etc.

ii) No blood pressure (SBP, DBP, or MAP) increases more than 20% from baseline in response to any major operational procedures or noxious stimulus in defined period.

iii) Subjects maintain desired depth of anesthesia for general elective surgery with BIS as an objective assessment (after reaching initial lowest value, BIS remains sustainable level at not more than 60).

b) No significant respiratory depression, such as apnea, prior to the administration of rocuronium bromide.

c) No significant cardiac depression indicated by blood pressure decrease that requires intervention, i.e., vasopressors and/or IV fluid resuscitation.

Outcome measures

Measure	HSK3486 n=255 Participants HSK3486 for general anesthesia induction HSK3486: HSK3486 for induction of general anesthesia	Propofol n=128 Participants Propofol for general anesthesia induction Propofol: Propofol for induction of general anesthesia.
Percentage of Subjects With Successful Induction Who Maintain the Desired Depth of Anesthesia for General Elective Surgery, AND Without Significant Cardiac and Respiratory Depression	88 Participants	53 Participants

SECONDARY outcome

Timeframe: From start of drug administration to MOAA/S ≤1 (up to 3 minutes)

0 = No Pain 1-3 = Mild Pain 4-6 = Moderate Pain 7-9 = Severe Pain 10 = Worst pain imaginable

Outcome measures

Measure	HSK3486 n=255 Participants HSK3486 for general anesthesia induction HSK3486: HSK3486 for induction of general anesthesia	Propofol n=128 Participants Propofol for general anesthesia induction Propofol: Propofol for induction of general anesthesia.
Percentage of Subjects With Any Injection-site Pain on Numeric Rating Scale ≥1	42 Participants	58 Participants

Adverse Events

HSK3486

Serious events: 6 serious events

Other events: 178 other events

Deaths: 0 deaths

Propofol

Serious events: 2 serious events

Other events: 89 other events

Deaths: 0 deaths

Serious adverse events

Measure	HSK3486 n=255 participants at risk HSK3486 for general anesthesia induction HSK3486: HSK3486 for induction of general anesthesia	Propofol n=129 participants at risk Propofol for general anesthesia induction Propofol: Propofol for induction of general anesthesia.
Vascular disorders Hypotension	0.39% 1/255 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	0.00% 0/129 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Injury, poisoning and procedural complications Post-procedural hemorrhage	0.78% 2/255 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	0.00% 0/129 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Psychiatric disorders Confusional state	0.39% 1/255 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	0.00% 0/129 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Infections and infestations Urinary tract infection	0.39% 1/255 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	0.00% 0/129 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Metabolism and nutrition disorders Hypocalcemia	0.39% 1/255 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	0.00% 0/129 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Vascular disorders Ischemic stroke	0.00% 0/255 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	0.78% 1/129 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Gastrointestinal disorders Hiatus hernia	0.00% 0/255 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	0.78% 1/129 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.

Other adverse events

Measure	HSK3486 n=255 participants at risk HSK3486 for general anesthesia induction HSK3486: HSK3486 for induction of general anesthesia	Propofol n=129 participants at risk Propofol for general anesthesia induction Propofol: Propofol for induction of general anesthesia.
Vascular disorders Hypotension	20.4% 52/255 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	22.5% 29/129 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Gastrointestinal disorders Nausea	20.4% 52/255 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	19.4% 25/129 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Injury, poisoning and procedural complications Procedural Pain	14.9% 38/255 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	18.6% 24/129 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
General disorders Asthenia	14.1% 36/255 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	17.8% 23/129 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Vascular disorders Hypertension	11.8% 30/255 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	11.6% 15/129 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Vascular disorders Procedural Hypotension	8.2% 21/255 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	13.2% 17/129 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Nervous system disorders Dizziness	5.9% 15/255 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	4.7% 6/129 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Gastrointestinal disorders Vomitting	6.3% 16/255 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	3.9% 5/129 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.5% 14/255 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	4.7% 6/129 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Cardiac disorders Bradycardia	5.1% 13/255 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	3.9% 5/129 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.
Gastrointestinal disorders Constipation	1.6% 4/255 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.	5.4% 7/129 • Adverse Events (AEs) will be collected from the time of informed consent until the final study visit (Day 8). A treatment-emergent AE is defined as: an AE that occurs after the subject starts treatment with the IMP. If an Investigator becomes aware of a serious adverse event within 30 days after the last dose of study drug and it is considered by him/her to be caused by the study drug with a reasonable possibility, the event must be documented and reported. Adverse Events of Special Interest (AESIs) due to pharmacological effect of an anesthetic agent include hypoxemia, bradycardia, severe hypotension, allergy/anaphylaxis, cardiac arrhythmia and QTc prolongation.

Additional Information

Yu-Ling Lai

Haisco-USA Pharmaceuticals, Inc.

Phone: 858-263-4239

Email: yuling.lai@haisco-usa.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60