Effect of Intravenous Fluid Therapy on Postoperative Vomiting in Children Undergoing Otorhinolaryngological Surgery
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Region Metropolitana
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Santiago、Region Metropolitana、智利
- Hospital Clínico Universidad Católica
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- ASA physical status I or II
- Age 1-12 yr
- Scheduled for elective tonsillectomy or adenotonsillectomy
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:10 mL/kg/h lactated Ringer's solution
Group 1, 10 mL/kg/h lactated Ringer's solution
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After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 mL/kg/h lactated Ringer's solution; Group 2, 30 mL/kg/h lactated Ringer's solution.
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实验性的:30 mL/kg/h lactated Ringer's solution
Group 2, 30 mL/kg/h lactated Ringer's solution
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After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 mL/kg/h lactated Ringer's solution; Group 2, 30 mL/kg/h lactated Ringer's solution.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Vomiting at 24 hours postoperative
大体时间:First 24 hours postoperative
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Presence of at least one episode of vomiting in the first 24 hours postoperative
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First 24 hours postoperative
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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