Effect of Intravenous Crystalloid Volume on Postoperative Nausea and Vomiting After Tonsillectomy and/or Adenoidectomy: a Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Postoperative Vomiting
研究概览
简要总结
Postoperative nausea and vomiting is very common in children undergone tonsillectomy and/or adenoidectomy. The purpose of this clinical trial is to evaluate the antiemetic effect of super-hydration with 0.9% saline in children undergoing specifically elective otorhinolaryngological surgery. Fluid intake reduces vomiting as seen following extended period of fasting that interrupts the perfusion in gut. Based on this knowledge, we hypothesized that administration of supplemental fluid would reduce the incidence of postoperative vomiting.
详细描述
At the initiation of the study, 160 patients we enrolled consecutively . Six of the patients were excluded according to the inclusion/exclusion criteria. Remaining one hundred fifty four were American Society of Anesthesia (ASA) I-II classified children , aged 2-15 yr, undergoing elective tonsillectomy, with or without adenoidectomy, under general anesthesia . Induction and maintenance of anesthesia were standardized with fentanyl, lidocaine, rocuronium and sevoflurane in nitrous oxide (N(2)O). Subjects were assigned to two groups administered with saline solution (%0.9 saline) at different rates; either 10 ml/kg/h or 20ml/kg/h delivery arms.
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
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I or II
- •Age 2-15 yr
- •Scheduled for elective tonsillectomy and/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
Group 2
intravenous administration of 20 ml/kg/h 0.9% saline solution
干预措施: Group 2 (Other)
Group 1
intravenous administration of 10 ml/kg/h 0.9% saline solution
干预措施: Group 1 (Other)
结局指标
主要结局
Postoperative Vomiting
时间窗: First 24 hours postoperative
Presence of at least one episode of vomiting within the first 24 hours of postoperative is positive for definition
次要结局
未报告次要终点
研究者
SİNAN YILMAZ
Associate Professor
Aydin Adnan Menderes University