跳至主要内容
临床试验/NCT00402870
NCT00402870已完成不适用

Postoperative Analgesic Requirements for the ProSeal Laryngeal Mask Airway Versus the Tracheal Tube in Females Undergoing Gynecological Laparoscopic Surgery

Medical University Innsbruck2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年8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
100
试验地点
2
主要终点
Postoperative analgesia

研究概览

简要总结

The ProSeal laryngeal mask airway is a relatively new airway device with a modified cuff to increase the seal and a drain tube to provide a channel for regurgitated fluid, prevention of gastric insufflation and insertion of a gastric tube. In the following randomized prospective double-blind trial, we test the hypothesis that the postoperative analgesic requirements is higher for the ProSeal laryngeal mask airway than the tracheal tube.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18-75
  • Elective laparoscopic surgery

排除标准

  • Known or predicted difficult airway
  • Oropharyngeal pathology
  • Mouth opening < 3.0 cm
  • A body mass index > 35 kg m-2
  • Increased risk of aspiration
  • Inability to communicate or understand the visual analogue scale
  • Analgesics within 24 hours of surgery

结局指标

主要结局

Postoperative analgesia

时间窗: 24 hrs

次要结局

未报告次要终点

研究者

发起方
Medical University Innsbruck
申办方类型
Other

研究点 (2)

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