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临床试验/NCT00392522
NCT00392522Unknown3 期

50% Nitrous Oxide and 50% Oxygen (MEOPA) Conscious Sedation Versus Placebo in Fiberoptic Bronchoscopy : Randomized, Double Blind, Placebo-Controlled Study

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2006年11月最近更新:
适应症
相关药物

试验速览

阶段
3 期
入组人数
64
试验地点
2
主要终点
Efficacy in term of pain control Visual Analogic Scale

研究概览

简要总结

Fiberoptic bronchoscopy may generate pain, anxiety or cough and dyspnea. It may then induce discomfort and then run down its yield. Systematic local anaesthesia does not always suffice and FOB may be conducted under general anaesthesia. Premixed nitrous oxide and oxygen (MEOPA) could be efficient to avoid general anesthesia risks and to reduce organizational costs. Nitrous oxide induces anaelgesia and anxiolysis when administered in oxygen at a 50% concentration.

MEOPA is being delivered in France for every short painful medical in-patients procedure since 2001. At a concentration of 50% in oxygen, and delivered through a facial mask, it produces a conscious sedation useful during endoscopy. MEOPA safety is due to its short term effect, which ends 5 minutes after cessation of inhalation. It therefore allows ambulatory medicine.

Two randomized double blind controlled studies were driven in fiberoptic bronchoscopy (Fauroux 2004, Atassi 2005) and showed its efficacy on pain control and sedation.

We will perform our Study to estimate MEOPA efficacy in term of pain control (Visual Analogic Scale (VAS)), anxiety control (COVI Scale), cough and number of general anaesthesias, comparing FOB under MEOPA and Oxygen (double blind, randomized, placebo-controlled study.

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
Double

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Man or woman over 18 who should undergo a fiberoptic bronchoscopy (inpatient and outpatient)

排除标准

  • Child under 18
  • Pneumothorax
  • ocular surgery in the previous 3 months,
  • intracranial overpressure
  • lucidity impairment
  • emphysema bullae
  • face trauma
  • angina pectoris
  • hemodynamic instability
  • acute respiratory distress
  • hypercapnia > 45 mm Hg
  • pregnancy
  • lidocaine allergia
  • lack of approuval from the patient to perform the study will of the patient to undergo FOB with premixed nitrous oxide-oxygen

结局指标

主要结局

Efficacy in term of pain control Visual Analogic Scale

次要结局

  • anxiety control (COVI Scale)
  • cough
  • number of general anaesthesias

研究者

申办方类型
Other

研究点 (2)

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