NCT05478174

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Haisco-USA Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Detailed description

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 with endotracheal intubation. After screening, eligible subjects will be randomized in a 2:1 ratio to receive either HSK3486 0.4/0.2 mg/kg (i.e., 0.4 mg/kg IV slow injection over 30 \[±5\] seconds followed by an additional 0.2 mg/kg dose over 10 \[±2\] seconds if needed) or propofol 2.0/1.0 mg/kg (i.e., 2.0 mg/kg IV slow injection over 30 \[±5\] seconds followed by an additional 1.0 mg/kg dose over 10 \[±2\]seconds if needed) in a blinded manner. Enrolled subjects will be stratified by American Society of Anesthesiologists Physical Status (ASA-PS; I-II and III-IV), age (\<65 and ≥65 years), and Body Mass Index (BMI \<35 and ≥35 kg/m2). Endotracheal intubation will be performed after adequate anesthetic induction (Modified Observer's Assessment of Awareness/Sedation \[MOAA/S\] ≤1) (Appendix 1) has been achieved and administration of neuromuscular blocking agent. Before surgery, premedication is allowed except for sedative-hypnotic or analgesic drugs. Premedication should be recorded if used. Prior to administration of the study drug in the operating room, the preoperative readiness of each subject will be confirmed. Oxygen will be supplied through a facemask (oxygen flow rate: ≥4 L/min) at least 2 minutes before study drug administration. Subsequently, the investigator can adjust the oxygen flow according to the specific situation of the subject and maintenance IV solution (normal saline \[NS\], lactated ringer's \[LR\], or 5% dextrose) will be administrated through IV infusion. Throughout the preinduction and induction periods, a timing device must be used to allow accuracy and sequencing of necessary assessments.

Conditions

• General Anesthesia

Interventions

Type	Name	Description
DRUG	HSK3486	HSK3486 for induction of general anesthesia
DRUG	Propofol	Propofol for induction of general anesthesia.

Timeline

• Start date: 2022-07-26
• Primary completion: 2023-11-07
• Completion: 2023-11-14
• First posted: 2022-07-28
• Last updated: 2025-10-10
• Results posted: 2024-10-29

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study