NCT06170476

A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in PONV

A Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Finding Study of HSK21542 Injection for the Prevention of Postoperative Nausea and Vomiting (PONV)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Sichuan Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled Dose-Finding study. About 200 subjects undergoing elective laparoscopic abdominal or gynecological surgery are planned to be enrolled and randomized into four groups by a ratio of 1:1:1:1.

Conditions

• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	HSK21542-60μg	HSK21542 injection of 60 μg was administered once within 15 min before the end of surgery, and was administered by intravenous bolus injection for no less than 30 s;
DRUG	HSK21542-120μg	HSK21542 injection of 120 μg was administered once within 15 min before the end of surgery, and was administered by intravenous bolus injection for no less than 30 s;
DRUG	HSK21542-180μg	HSK21542 injection of 180 μg was administered once within 15 min before the end of surgery, and was administered by intravenous bolus injection for no less than 30 s;
DRUG	Placebo	A placebo was administered once within 15 min before the end of surgery, and was administered by intravenous bolus injection for no less than 30 s;

Timeline

• Start date: 2023-11-10
• Primary completion: 2024-02-28
• Completion: 2024-05-15
• First posted: 2023-12-14
• Last updated: 2024-07-09

Locations

1 site across 1 country: China