Effect of Intravenous Fluid Therapy on Postoperative Vomiting in Children Undergoing Otorhinolaryngological Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Vomiting at 24 hours postoperative
研究概览
简要总结
The purpose of this randomized clinical trial is to evaluate the interaction of intravenous fluid therapy during otorhinolaryngological surgery, on postoperative vomiting. The hypothesis is that perioperative supplemental intravenous fluid administration reduces the incidence of postoperative vomiting.
详细描述
Postoperative vomiting is a common complication on pediatric surgery, especially otorhinolaryngological surgery. Is one of the main reasons of prolonged hospital stay, and also a cause of patient´s discomfort and an increase on hospitalization cost.
There are studies in adults with inconclusive results related to supplemental fluid therapy and decrease of postoperative nausea and vomiting. But, in recent years a study in children showed favorable results in strabismus surgery. The foundation of this study consist in that hypovolemia may possibly cause a decrease in perfusion causing intestinal hypoxia, which in turn increase the incidence of nausea and vomiting. The objective of this study is to observe the effect of supplemental fluid therapy on postoperative vomiting on otorhinolaryngological surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I or II
- •Age 1-12 yr
- •Scheduled for elective tonsillectomy or adenotonsillectomy
排除标准
- •History of diabetes
- •History of mental retardation
- •Obesity (BMI ≥95th percentile for age and sex)
- •Intake of antiemetic or psychoactive medication within 24 hours before surgery
- •Known gastroesophageal reflux
研究组 & 干预措施
10 mL/kg/h lactated Ringer's solution
Group 1, 10 mL/kg/h lactated Ringer's solution
干预措施: Intraoperative lactated Ringer's solution (Other)
30 mL/kg/h lactated Ringer's solution
Group 2, 30 mL/kg/h lactated Ringer's solution
干预措施: Intraoperative lactated Ringer's solution (Other)
结局指标
主要结局
Vomiting at 24 hours postoperative
时间窗: First 24 hours postoperative
Presence of at least one episode of vomiting in the first 24 hours postoperative
次要结局
未报告次要终点
研究者
Ignacio Cortínez F.
Profesor Asociado, Departamento de Anestesiología
Pontificia Universidad Catolica de Chile