Clinical Study of Aprepitant and Ondansetron Monotherapy or Combination in the Treatment of Postoperative Nausea and Vomiting in Thyroid Carcinoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Complete remission rate (CR rate)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-80 years;
- •Voluntary enrollment in the study and signing the informed consent form;
- •Diagnosed with thyroid cancer and needing surgical treatment;
排除标准
- •Patient has depression, history of chronic pain, insulin-dependent diabetes mellitus I or II, history of severe vomiting;
- •history of prior thyroid or neck surgery;
- •Cases in which surgery requiring sternotomy is anticipated;
- •History of long-term hormone use, period of immunosuppressive therapy;
- •pre-operative voice changes or laryngoscopic confirmation of vocal cord paralysis;
- •Pregnant or breastfeeding patients;
- •Patients who are allergic to any of the study medications;
- •Patients who have received any sedative, hypnotic, anxiolytic, opioid, steroid or other antiemetic medication within 24 hours prior to the procedure;
- •Patients taking or planning to take a combination of drugs such as rifampicin, carbamazepine, phenytoin or other drugs that strongly induce CYP3A4 activity;
- •patients with other malignant tumors;
- •Patients with hypothyroidism;
- •Participating or planning to participate in other clinical studies.
研究组 & 干预措施
Ondansetron group
Patients in the ondansetron group received 8 mg of ondansetron orally 1 hour before anesthesia and twice at 8-hour intervals thereafter
干预措施: Ondansetron 8mg (Drug)
Arepitant group
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)
干预措施: Aprepitant 125 mg (Drug)
Combined treatment group
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)
干预措施: Ondansetron 8mg (Drug)
Combined treatment group
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)
干预措施: Aprepitant 125 mg (Drug)
结局指标
主要结局
Complete remission rate (CR rate)
时间窗: Within 24 hours after surgery
Complete remission rate (CR rate) without vomiting within 24h postoperatively and without resolution
次要结局
- Complete remission rate (CR rate)(Within 48 hours after surgery)
- Rate of no vomiting(Within 24 and 48 hours after surgery)
- Incidence of adverse events and serious adverse events(up to 24 weeks)
研究者
Shumin Dong
Clinical Professor
The First Affiliated Hospital of Zhengzhou University