The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
NCT Number: NCT06697782
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Phase 4
Zhengzhou, Henan, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients in the ondansetron group received 8 mg of ondansetron orally 1 hour before anesthesia and twice at 8-hour intervals thereafter
Other names: AD
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)
Other names: AR
Time frame: Within 24 hours after surgery
Complete remission rate (CR rate) without vomiting within 24h postoperatively and without resolution
Time frame: Within 48 hours after surgery
Complete remission rate (CR rate) without vomiting within 48h postoperatively and without resolution
Time frame: Within 24 and 48 hours after surgery
Rate of no vomiting within 24h, 48h
Time frame: up to 24 weeks
Adverse events and serious adverse events
The First Affiliated Hospital of Zhengzhou University
Other
Clinical Study of Aprepitant and Ondansetron Monotherapy or Combination in the Treatment of Postoperative Nausea and Vomiting in Thyroid Carcinoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01833650
Endocrine Gland Neoplasms, Endocrine System Diseases
Nicosia, Cyprus
View Trial DetailsNCT03345563
Bladder Cancer, Colon Cancer
New Brunswick, New Jersey, United States
View Trial DetailsNCT04000880
Adnexal Diseases, Behavior
Birmingham, Alabama, United States
View Trial DetailsNCT05708950
Adnexal Diseases, Breast Cancer
Santa Monica, California, United States
View Trial Details