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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
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;
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;
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;
Sichuan Provincial People's Hospital
Sichuan, China
Complete response
The primary efficacy analysis was the complete response (CR)within the 24 hours after the end of surgery (CR was defined as no vomiting or retching and on use of rescue medication)
Time frame: 24 hours after the end of surgery
Proportion of subjects experiencing nausea within 24 hours after the end of surgery
Nausea (defined as a feeling of urgency to vomit, characterized by merycism and/or urgent vomiting) measured on a 0-10 verbal response scale\[VAS\], where 0=no nausea at all and 10=the worst nausea that cannot be tolerated
Time frame: 24 hours after the end of surgery
Proportion of subjects experiencing significant nausea within 24 hours after the end of surgery
Significant nausea is defined as VAS score ≥ 4 cm
Time frame: 24 hours after the end of surgery
Proportion of subjects experiencing vomiting within 24 hours after the end of surgery
vomiting \[even with the expulsion of scanty gastric contents\] or retching \[presence of vomiting muscle movement without the expulsion of gastric contents\])
Time frame: 24 hours after the end of surgery
Proportion of subjects using rescue medication within 24 hours after the end of surgery
Any drug given in the post-operative period with the intention of providing anti-emetic rescue is counted as rescue anti-emetic medication
Time frame: 24 hours after the end of surgery
Time to first occurrence of vomiting or rescue therapy (whichever occurs first) within 24 hours after the end of surger
Vomiting includes vomiting or retching
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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;
Time frame: 24 hours after the end of surgery
The cumulative morphine doses administered within 24 hours after the end of surgery
Morphine as the postoperative analgesics
Time frame: 24 hours after the end of surgery
PONV Satisfaction Score by Subject and Investigator
Satisfaction Score rating range 0-10,where 0=not satisfactory at all, and 10=the most satisfactory
Time frame: 24 hours after the end of surgery