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临床试验/EUCTR2014-003720-43-CZ
EUCTR2014-003720-43-CZ进行中(未招募)1 期

Prevention of nicotine abstinence in critically ill patients after major surgery - NIKOTI

Fakultní nemocnice Ostrava0 个研究点目标入组 100 人开始时间: 2014年10月3日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
100

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 older than 18 years.
  • Patients with the assumption of nicotine abstinence. Prerequisite sudden nicotine abstinence as a risk factor for development of delirium will be assessed by the Test for Nicotine Dependence according to the Fagerstrom. The questionnaire will be filled by the patient within medical examination before anesthesia.
  • Patients included in the group of patients undergoing major surgery within the abdominal region, urology and thoracic surgery and to subsequent ICU clinics KARIM FNO> 48 hours. Presumption of hospitalization in the ICU clinics KARIM FNO> 48 hours will be determined based on the prediction of the medical assessment.
  • Obtaining informed consent (signed and dated) approved MEK.
  • 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 80
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • Age <18 years.
  • failure to obtain informed consent approved by the Ethics Committee.
  • Patients undergoing neurosurgical operation, patients diagnosed with cranial trauma.
  • Patients diagnosed with psychiatric illness.
  • Known allergy to nicotine or any other component of the transdermal patch NiQuitin CLEAR 21 mg.
  • Known allergy to surgical bandage Curapor.
  • patients with recent heart attack, unstable or worsening angina or patients with serious heart rhythm disorders, patients with a fresh stroke.
  • Pregnant and nursing women.
  • Patients with concomitant treatment with products containing nicotine.

研究者

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