Efficacy and Safety Study of Aprepitant Injection for Prevention of Post-operative Nausea and Vomiting

A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Aprepitant Injection(QLG2174) in the Prevention of Post-operative Nausea and Vomiting

The goal of this Interventional study is to evaluate the efficacy and safety of Aprepitant Injection(QLG2174) for preventing PONV in Chinese patients.

Inclusion Criteria:

• aged 18 to 70 years, with a body mass index (BMI) of 18-30 kg/m² and body weight≥45kg.
• laparoscopic gynecologic or abdominal surgery under general anesthesia (duration≥1 hour and postoperative hospitalization ≥24 hours), with anesthesia maintained using sevoflurane and remifentanil (propofol maintenance was prohibited);
• had≥2 risk factors of PONV; expected to use postoperative opioid within 24 hours after surgery;
• American Society of Anesthesiologists (ASA) physical status class I-III.

Exclusion Criteria:

• planned intrathoracic, transplant, or central nervous system surgeries;
• diagnostic-only procedures;
• use of local/regional anesthesia (e.g., neuraxial/nerve blocks);
• postoperative intensive care unit (ICU) transfer;
• preoperative nasogastric/orogastric tube placement (from screening through 24 hours postoperatively)
• nausea, vomiting, retching, or organic disease-related emesis (e.g., intestinal obstruction) within 24 hours preoperatively; history of malignancy, epilepsy, or vestibular dysfunction;
• hypersensitivity to aprepitant;
• recent use of aprepitant/NK1 antagonists (within 2 weeks prior to randomization), antiemetics (including 5-HT3 antagonists, corticosteroids; within 1 week), strong CYP3A4 inhibitors/substrates (within 1 week), CYP3A4 inducers (within 4 weeks), or warfarin (within 2 weeks);
• clinically significant laboratory abnormalities (ALT/AST ≥2×upper limit of normal [ULN], total bilirubin ≥1.5×ULN, creatinine ≥1.5×ULN, hemoglobin ≤90 g/L)