Intravenous Dexamethasone Palmitate for Prophylaxis of Postoperative Nausea and Vomiting After Craniotomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The incidence of PONV
研究概览
简要总结
Dexamethasone is almost one of the most commonly used drugs for postoperative nausea and vomiting (PONV) prevention. However, PONV is still a complex problem to be solved; for example, even with preoperative dexamethasone administration, there are still some patients undergoing craniotomy still experience PONV within 24 hours postoperatively. Compared to dexamethasone, dexamethasone palmitate has a long-lasting anti-inflammatory effect, 2-5 times that of traditional water-soluble dexamethasone, with fewer adverse effects. This trial aims to assess the effect and safety of preoperative dexamethasone palmitate on PONV after craniotomy.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 65 years;
- •Providing written informed consent;
- •Perform elective craniotomy undergoing general anesthesia.
排除标准
- •Known to be allergic to dexamethasone;
- •Any systemic glucocorticoids within 3 months before trial entry;
- •History of severe heart disease, liver/kidney failure, or systemic rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, et al);
- •Cognitive impairment or severe mental illness;
- •Uncontrolled diabetes or infectious diseases;
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Dexamethasone palmitate group
干预措施: Dexamethasone Palmitate (Drug)
Dexamethasone group
干预措施: Dexamethasone (Drug)
结局指标
主要结局
The incidence of PONV
时间窗: Within the first 24 hours postoperatively
PONV will be defined as any nausea, emetic episodes (vomiting or retching), or both. Nausea is defined as an unpleasant sensation with an urge to vomit. Vomiting is defined as the physical event of forcefully expelling gastric contents through the mouth. Retching refers to the forced movement of gastrointestinal contents without actual expulsion of vomitus.
次要结局
- The VAS scale(At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively)
- Postoperative length of stay (LOS)(Within 1 month postoperatively)
- Safety outcomes(Within 1 month postoperatively)
- The Incidence of PONV(At 6 hours, 48 hours, and 72 hours postoperatively)
- Incidence of postoperative nausea (PON) and postoperative vomiting (POV)(At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively)
- The number of vomiting or retching episodes(Within 6 hours, 24 hours, 48 hours, and 72 hours postoperatively)
- The severity of PONV(At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively)
- Participant satisfaction with PONV management(At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively)
- The use of rescue antiemetic drugs(During the 0-24 hours, 24-48 hours, and 48-72 hours postoperatively)
- The quality of postoperative recovery (QoR)(At 24 and 48 hours postoperatively, discharge, and 1 month postoperatively)
研究者
Fang Luo
Director of Department of Pain Management
Beijing Tiantan Hospital