At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 465 enrolled
Drug / intervention
HSK3486 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Global 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
In Brief
A Phase 3 clinical trial evaluating HSK3486 and Propofol for General Anesthesia. Completed, enrolled 465 participants across 28 sites in 3 countries.
Detailed Summary
To demonstrate HSK3486 0.4/0.2 mg/kg (0.4 mg/kg intravenous \[IV\] slow injection over 30 \[±5\] seconds for the first dose, an additional 0.2 mg/kg if needed) is non-inferior to Propofol 2.0/1.0 mg/kg (2.0 mg/kg IV slow injection over 30 \[±5\] seconds for first dose, an additional 1.0 mg/kg if needed) in success of induction of general anesthesia in adults undergoing elective surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeneral Anesthesia
CountriesPoland, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedAug 2022
Enrollment StartJan 2024
Primary CompletionJul 2024
TodayJul 2026
First PostedAug 3, 2022
Enrollment StartJan 12, 2024
Primary CompletionJul 23, 2024
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 3.9 years ago
Interventions
HSK3486drug
HSK3486 for induction of general anesthesia
Propofoldrug
Propofol for induction of general anesthesia