Laryngeal Mask or Endotracheal Tube for Back Surgery in the Prone Position. Advantages, Adverse Effects and Time Consumation for the Two Methods.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- time of anaesthesia
研究概览
简要总结
The aim of the study is to compare anaesthesia (for back surgery) using endotracheal intubation (patients anaesthized in the supine position)with anaesthesia using a laryngeal mask (anaesthesia induced and the laryngeal mask placed with the patient in the prone position on the operation table) as regards advantages, adverse effects and time spent. The anaesthesia in the 2 groups of patients is identical (propofol, remifentanil, rocuronium). Two groups of 70 pt. each are included in the stud. The inclusion criterias are patients 18-70 yrs., ASA group 1-2, normal airways, patients scheduled for back surgery with an estimated duration of less than 2 hours.
Adverse effects (related to the placement on the operation table i.e. pain in the arms or shoulders, pain in the throat, blood in the sputum, irritation in the eyes etc.) and time spent with all the procedures (anaesthesia, placement of the airway, surgery and emergence from the anaesthesia are registered. The hypothesis is that the method using the laryngeal mask is faster and with fewer adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for backsurgery of an espected duration less than 2 hours,
- •Age 18-70 years,
- •ASA (american society of anaaesthesiology) class 1-2,
- •Normal airways
排除标准
- •Body mass index >35
- •Expected time of surgery > 2 hours
结局指标
主要结局
time of anaesthesia
时间窗: 2 years
次要结局
- adverse effects using the 2 methods(2 years)
研究者
Karsten Skovgaard Olsen
Consultant, DMSC
Glostrup University Hospital, Copenhagen
