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临床试验/NCT01041352
NCT01041352已完成不适用

Laryngeal Mask or Endotracheal Tube for Back Surgery in the Prone Position. Advantages, Adverse Effects and Time Consumation for the Two Methods.

Glostrup University Hospital, Copenhagen2 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2009年10月1日最近更新:
适应症

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

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

发起方
Glostrup University Hospital, Copenhagen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karsten Skovgaard Olsen

Consultant, DMSC

Glostrup University Hospital, Copenhagen

研究点 (2)

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