Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery (PONVACS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 502
- 试验地点
- 1
- 主要终点
- postoperative nausea and vomiting
研究概览
简要总结
To investigate the role of postoperative nausea and vomiting risk factors assessment after cardiac surgery. We designed a randomized controlled study comparing standard care (no risk factor assessment and no intervention) with prophylaxis of postoperative nausea and vomiting after cardiac surgery in high risk patients. Prophylaxis of postoperative nausea and vomiting by betamethasone (4mg) and/or droperidol (0.625mg) immediately after cardiac surgery, depending on risk factors (if risk score is over 2) in the intervention arm.
详细描述
Patients planned to undergo cardiac surgery were screened for inclusion. Inclusion criteria are as follow: Non emergent cardiac surgery; Age > 18 years; Affiliation to French Social Security; Approval of participation to the study; at the exclusion of: Pregnancy ; Contra indication to antiemetics; Chronic usage of antiemetics; and Emergent or complicated surgery.
Risk factors for postoperative nausea and vomiting were collected and patients were randomized by cluster into two arms.
Control: No prophylaxis whatever risk score is. Postoperative nausea and vomiting risk factors were not available for practicians.
Intervention: Preoperative collection of postoperative nausea and vomiting risk factors available for practicians. Prophylaxis if risk score is over 2. Prophylaxis of postoperative nausea and vomiting by betamethasone (4mg) and/or droperidol (0.625mg) immediately after cardiac surgery, depending on risk factors in the intervention arm.
All outcomes are assessed at 48 hours of surgery:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non emergent cardiac surgery
- •Age > 18 years
- •Affiliation to French Social Security
- •Approval of participation to the study
排除标准
- •Pregnancy
- •Contra indication to antiemetics
- •Chronic usage of antiemetics
- •Emergent or complicated surgery
研究组 & 干预措施
postoperative nausea and vomiting risk factors
Preoperative collection of postoperative nausea and vomiting risk factors available for practicians.
干预措施: Betamethasone (Drug)
postoperative nausea and vomiting risk factors
Preoperative collection of postoperative nausea and vomiting risk factors available for practicians.
干预措施: Droperidol (Drug)
结局指标
主要结局
postoperative nausea and vomiting
时间窗: 48hour
postoperative nausea and vomiting as a categorical variable
次要结局
- number of postoperative nausea and vomiting(48hour)
- postoperative nausea and vomiting (VAS)(48hour)
- postoperative pain (VAS)(48hour)
- postoperative discomfort (VAS)(48hour)
- Antiemetics (treatment)(48hour)
- Analgesics(48hour)
- Side effects(48hour)
- QTc interval(48hour)
研究者
Sébastien CHAMPION
Dr
Hôpital Privé de Parly II - Le Chesnay