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临床试验/EUCTR2015-003095-68-ES
EUCTR2015-003095-68-ES进行中(未招募)1 期

Randomized cross-over open-label clinical trial to compare the videoendoscopic examination with induced sleep after sedation with propofol or clonidine

Fundació Parc Taulí0 个研究点开始时间: 2016年4月20日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Patients between 18 and 65 years old
  • - Patients with ASA (American Society of Anesthesiologists) criteria I or II
  • - Patients with Apnea-Hypopnea sleep syndrome of moderate or severe intensity, with no morbid obesity and who do not tolerate CPAP (continuous positive airway pressure)
  • Patients with Apnea-Hypopnea syndrome in which the surgical treatment with mandibular advanced device is indicated
  • - Patients with Apnea-hypopnea sleep syndrome who have not responded to surgical treatment
  • - Informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 16
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 2

排除标准

  • Age < 18 or > 65 years old
  • Alergic to propofol (ie soya bean or egg) or to clonidine
  • High surgical risk (ASA III or higher)
  • Severe cardiaack blockage (grade 2-3) without a pace maker
  • Non controlled hypotension
  • Severe cardiovascular disease

研究者

发起方
Fundació Parc Taulí

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