The Effects of Different Airway Devices on Middle Ear Pressure in Pediatric Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Middle ear pressure changes after the device application (MEP)
研究概览
简要总结
Even though the effects of anesthetic agents both inhalation and intravenous have been well described, the effect of laryngeal mask airways haven't. The purpose of the study is to determine the effects of different types of laryngeal mask airways on middle ear pressure.
详细描述
All the patients in each group of laryngeal mask airway will contain 20 patients. In all groups middle ear pressures will be measured, in both right and left ear, preoperatively, after induction of anesthesia, insertion of laryngeal mask and in 1st., 5th., 10th. minutes and every 5 minutes perioperatively and recorded. Also the heart rates,arterial oxygen saturation (SaO2), airway pressures and end-tidal carbon dioxide values will be recorded before and following induction of anesthesia and in 1st., 5th., 10th. minutes and every five minutes perioperatively. Patients will be followed during the hospital stay for any complications.In all groups premedication will be done with midazolam. Anesthesia will be inducted with propofol and fentanyl; and maintained with sevoflurane-air combination.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective patients undergoing subumbilical surgery under general anesthesia
排除标准
- •Emergency conditions
- •Rejection of patient approval
- •Tympanic membrane perforation history
- •Anticipated difficult airway
- •Contraindications for LMA application
结局指标
主要结局
Middle ear pressure changes after the device application (MEP)
时间窗: Perioperative
次要结局
- Composite Hemodynamics(Perioperative)
研究者
Dr. Ülkü Sabuncu
Dr
Adiyaman University Research Hospital