Triple Combination of Fosaprepitant, Dexamethasone and Palonosetron Versus Combination of Dexamethasone and Palonosetron for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastrointestinal Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,154
- 试验地点
- 1
- 主要终点
- Proportion of participants with PONV during the first 24 postoperative hours
研究概览
简要总结
Postoperative nausea and vomiting (PONV) are common in patients, especially in patients at high risk. PONV may result in prolonged hospital stay and threaten patients' life. Because the etiology of PONV is very complex, there is an increasing focus on combining antiemetics from different classes for PONV prophylaxis. Fosaprepitant is a neurokinin-1 (NK-1) receptor antagonist to prevent PONV. Palonosetron is a 5-HT3 receptor antagonist with high efficacy and sustained action for PONV prophylaxis. Dexamethasone belongs to corticosteroid and also has the ability to reduce the incident of PONV. This study aims to use the combination of these three drugs in high-risk patients to test whether triple therapy is better than combination of palonosetron and dexamethasone to prevent PONV.
详细描述
This trial is a prospective, randomized controlled study with blinded participant, care provider, investigator, and outcomes assessor. 1154 patients aged 18 to 75 years undergoing laparoscopic gastrointestinal surgery will be enrolled.Triple therapy of palonosetron and dexamethasone plus fosaprepitant will be administered in the intervention group, and double therapy of palonosetron and dexamethasone will be used in the control group. The anxiety of patients will be evaluated. The primary outcome is proportion of participants with PONV during the first 24 postoperative hours. Secondary outcomes are as follow: proportion of participants with PONV,emetic episodes, nausea, with rescue antiemetic medication; the scores of QOR-15; pain scores;time to first flatus after surgery; time to first defecation after surgery; recovery time; health related quality of life; proportion of participants with adverse events.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and Age ≤75 years;
- •Scheduled for laparoscopic gastrointestinal surgical procedure with general anesthesia ;
- •The score evaluated by Apfel simplified PONV risk assessment systems is ≥3.
排除标准
- •The American Society of Anesthesiologists (ASA) rating is >3;
- •Severe hepatic dysfunction(the score of Child-Pugh is >9);
- •With contraindications for using fosaprepitant, 5-HT3 receptor antagonist or dexamethasone ;
- •Take medications with known antiemetic properties preoperatively ;
- •With mental disorder, or not be able to communicate ;
- •Pregnant women or nursing mothers.
研究组 & 干预措施
triple therapy
Triple combination of Fosaprepitant, Palonosetron and Dexamethasone were administered
干预措施: palonosetron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl (Drug)
double therapy
double combination of Palonosetron and Dexamethasone were administered
干预措施: palonosetron, dexamethasone, and 0.9% NaCl (Drug)
结局指标
主要结局
Proportion of participants with PONV during the first 24 postoperative hours
时间窗: from operation completion to 24-hour after surgery (up to 24 hours)
PONV is defined as nausea, retching or vomiting
次要结局
- Proportion of participants with nausea(calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery))
- Postoperative recovery score using 15-item quality of recovery scoring system(QoR-15) during each subsequent evaluation period (up to 120 hours)(evaluated at 24-hour, 72-hour, 120-hour after surgery(up to 120 hours after surgery))
- Proportion of participants with PONV(calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery))
- Proportion of participants with rescue antiemetic medication(calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery))
- Proportion of participants with emetic episodes(calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery))
- The severity of PONV(calculated at 24-hour, 72-hour, 120-hour after surgery(daily recorded up to 120 hours after surgery))
- Time to first flatus after surgery(evaluated at the time of first exhaust after surgery(expected average of 3 days after surgery))
- Time to first defecation after surgery(evaluated at the time of the first defecation after surgery(expected average of 6 days after surgery)
- Time to fulfill the criteria of hospital discharge (recovery time)(from operation completion to fulfill the criteria of hospital discharge(expected 6 days ))
- Health related quality of life(evaluated before surgery, at 120-hour and 30 days after surgery (up to 30 days）)
- Proportion of patients with adverse events (up to 30 days after surgery)(from drug administration to 30 days (30 days))
- Pain scores(evaluated at 24-hour, 72-hour, 120-hour after surgery(up to 120 hours after surgery))
研究者
YangZhao
deputy director
Sixth Affiliated Hospital, Sun Yat-sen University