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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ondansetron group | Other | Patients in the ondansetron group received 8 mg of ondansetron orally 1 hour before anesthesia and twice at 8-hour intervals thereafter |
|
| Arepitant group | Other | 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) |
|
| Combined treatment group | Experimental | Patients in the combined group received 125 mg of oral aprepitant plus 8 mg of ondansetron 1 hour before anesthesia, with ondansetron followed by two oral doses of the drug at 8-hour intervals, and 80 mg of aprepitant once daily in the morning on postoperative days 2 and 3 (the day of the surgery was day 1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron 8mg | Drug | Patients in the ondansetron group received 8 mg of ondansetron orally 1 hour before anesthesia and twice at 8-hour intervals thereafter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate (CR rate) | Complete remission rate (CR rate) without vomiting within 24h postoperatively and without resolution | Within 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate (CR rate) | Complete remission rate (CR rate) without vomiting within 48h postoperatively and without resolution | Within 48 hours after surgery |
| Rate of no vomiting | Rate of no vomiting within 24h, 48h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Detao Yin, M.D. | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| D000077608 | Aprepitant |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Aprepitant 125 mg | Drug | 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) |
|
|
| Within 24 and 48 hours after surgery |
| Incidence of adverse events and serious adverse events | Adverse events and serious adverse events | up to 24 weeks |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D009025 | Morpholines |
| D010078 | Oxazines |