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临床试验/NCT01035021
NCT01035021已完成不适用

Effect of Neuromuscular Blockade on the Insertion of ProSeal™ Laryngeal Mask Airway and Postoperative Pharyngolaryngeal Discomfort

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2009年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1
主要终点
success rate and insertion time

研究概览

简要总结

The aim of this study is to evaluate the success rate, insertion time and complication depending on the use of neuromuscular blocking agent when inserting the laryngeal mask airway (LMA).

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 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 18-70 year
  • american society of anesthesiologist status 1-2
  • elective general anesthesia

排除标准

  • known or predicted difficult airway
  • recent sore throat
  • mouth opening less than 2.5 cm
  • at risk of aspiration

研究组 & 干预措施

group N

Active Comparator

Anesthesia is induced with propofol and remifentanil and LMA is inserted by the standard technique according to eht manufacturer's instruction. Rocuronium is administered for the operation.

干预措施: use of rocuronium when the LMA is inserted (Drug)

group R

Active Comparator

Anesthesia is induced with a propofol and remifentanil and rocuronium 0.06 mg/kg is injected. Insertion of LMA is performed by the standard technique according to the manufacturer's instruction.

干预措施: use of rocuronium when the LMA is inserted (Drug)

结局指标

主要结局

success rate and insertion time

时间窗: when laryngeal mask airway is inserted

次要结局

  • complication after the remove of LMA - bleeding, sore throat(1 hour after the LMA is removed)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyo-Seok Na

Dr.

Seoul National University Bundang Hospital

研究点 (1)

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