NCT06697782

Aprepitant and Ondansetron Monotherapy or Combination for Postoperative Nausea and Vomiting in Thyroid Cancer

Clinical Study of Aprepitant and Ondansetron Monotherapy or Combination in the Treatment of Postoperative Nausea and Vomiting in Thyroid Carcinoma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The vast majority of patients treated prophylactically with "first-line" antiemetics in the 5-hydroxytryptamine (5-HT3) receptor antagonist class still have significant PONV. Combination therapies with different pharmacologic bases have the potential to reduce the incidence of PONV. This study is a multicenter, three-arm, prospective study to evaluate the efficacy and safety of aprepitant and ondansetron, monotherapy or in combination, in the prevention of nausea and vomiting after surgery for thyroid cancer.

Detailed description

Postoperative nausea and vomiting (PONV) is the most common complication after surgery, especially thyroidectomy, and the incidence of PONV can be as high as 80% without the administration of prophylactic antiemetics. Currently, available prophylactic interventions for PONV, especially monotherapy, lack universal efficacy. Combination therapy with a different pharmacologic basis has the potential to reduce the incidence of PONV. Previous studies using various 5-HT3 receptor antagonists in combination with aprepitant have shown promising results in reducing the incidence of PONV. The present study is a multicenter, three-arm, prospective study designed to evaluate the efficacy and safety of aprepitant and ondansetron, alone or in combination, in the prevention of postoperative nausea and vomiting in thyroid cancer.

Conditions

• Thyroid Cancer

Interventions

Type	Name	Description
DRUG	Ondansetron 8mg	Patients in the ondansetron group received 8 mg of ondansetron orally 1 hour before anesthesia and twice at 8-hour intervals thereafter
DRUG	Aprepitant 125 mg	Patients in the aprepitant group received 125 mg of aprepitant orally 1 hour before anesthesia and 80 mg orally once daily in the morning of postoperative days 2 and 3 (the day of the surgery was day 1)

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-12-01
• Completion: 2025-01-01
• First posted: 2024-11-20
• Last updated: 2025-01-22

Locations

1 site across 1 country: China