Effects of Intraoperative Fluid Infusion on Postoperative Vomiting in Pediatric Patients Undergoing Otorhinolaryngological Surgery
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
- 1
- 主要终点
- vomiting
研究概览
简要总结
Otorhinolaryngological surgery is one of the commonly applied procedures surgical treatments of children in the world. Postoperative vomiting (POV) is an important part of the management of pediatric anesthesia in this surgery that is also related with these surgical procedures. Postoperative vomiting is one of the most common complication of this surgery and may cause patients to receiving anesthesia again and stay longer in the hospital.The use of effective fluid therapy might be a safe way to reduce POV. There are many studies of fluid therapy adult patients on the other hands the number of children studies are limited.
The aim of this study was to evaluate the POV effect of intraoperative hydration with 0.9 NaCl solution in children undergoing otorhinolaryngological surgery.
详细描述
After institutional ethics committee approval and written informed parental consent, ASA physical status I or II, aged 2-14 year, who were undergoing elective day case otorhinolaryngological surgery under general anaesthesia, were screened for eligibility for enrollment in this prospective, randomized, double blind, placebo controlled study.
In the operating room, after routine monitoring, general anaesthesia was induced with %8 sevoflurane in 100% oxygen by a face mask with spontaneous ventilation.
Patients were randomly assigned to one of the two groups. Randomization was carried out using a computer-generated random numbers.
The control group (Group I) received ≤10 ml kg-1 h-1 and the high volüme group ( Group II) received >30 ml kg-1h-1 of intravenous %0.9 NaCl solution.Before tracheal intubation, all subjects received propofol 2:5mg kg-1, fentanyl 1µg kg-1 and rocuronium 0.6 mg kg-1.
After tracheal intubation, anaesthesia was maintained with 40% mixture of oxygen/nitrous oxide and 2% sevoflurane. The solution appears to be covered via an infusion pump was used. During anaesthesia, all patients received intravenous paracetamol 10 mg kg-1 for postoperative pain .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
The postoperative assessment following the anesthesiologist, nurse and parents were blind during the entire study group
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2-14 years
排除标准
- •Gastroesafageal reflu
- •Premedication antiemetic
研究组 & 干预措施
Group I (%0.9 NaCl 10ml/kg)
The group (Group 1) received 10 ml kg-1 throughout the entire surgical procedure.
Four point scale using scored vomiting. m CHEOPS Scale using scored between 0-10.
干预措施: %0.9 NaCl 10ml/kg (Drug)
Group II (%0.9 NaCl 20ml/kg)
The group (Group 2) received 30 ml kg-1 throughout the entire surgical procedure.
Four point scale using scored vomiting. m CHEOPS Scale using scored between 0-10.
干预措施: %0.9 NaCl 20ml/kg (Drug)
结局指标
主要结局
vomiting
时间窗: postoperative first 30 min
Both nausea and vomiting were assessed on a four point scale: 0=no nausea/vomit, 1=mild nausea/vomit, patient not requesting metoclopramide, 2=nausea/vomit, patient requesting metoclopramide and 3=nausea/vomit resistant to treatment
次要结局
- Pain(postoperative first 30 min)
研究者
SİNAN YILMAZ
Adnan Menderes University
Aydin Adnan Menderes University