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Completed PHASE4 INTERVENTIONAL NCT06697782

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

Name: Ondansetron 8mg
Type: DRUG
Description: Patients in the ondansetron group received 8 mg of ondansetron orally 1 hour before anesthesia and twice at 8-hour intervals thereafter
Name: Aprepitant 125 mg
Type: DRUG
Description: 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)

Primary Outcomes

Measure: Complete remission rate (CR rate)
TimeFrame: Within 24 hours after surgery
Description: Complete remission rate (CR rate) without vomiting within 24h postoperatively and without resolution

Trial Information

NCT ID

NCT06697782

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

The First Affiliated Hospital of Zhengzhou University

Last Updated

December 15, 2025