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临床试验/EUCTR2017-003225-15-IT
EUCTR2017-003225-15-IT进行中(未招募)1 期

Comparison between inhaled sedation with Sevoflurane vs endovenous sedation with Propofol in the Intensive Care Unit: a randomized prospective trial - HALO-IC

AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI0 个研究点目标入组 40 人开始时间: 2021年10月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
40

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

  • Consent, obtained during the preoperative period, for data treatment , randomization and participation in the study.
  • Age > 18 years
  • Pre-operative indications for post-operative monitoring in the ICU
  • 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 20
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • Pregnancy and breast feeding (women of childbearing age will be tested for the beta-HCG dosage to certainy exclude the pregnancy before the enrollment).
  • Known hypersensitivity to propofol, soy, peanut or any of the excipients of the emulsion, as well as allergic patients to soy or peanut.
  • Patients undergoing treatment with Cyclosporine.
  • Severe or suspected hypersensitivity to sevoflurane or other halogenated anesthetics (eg history of liver dysfunction, fever or leukocytosis of unknown cause after anesthesia with one of these agents).
  • Moderate to severe hepatic dysfunction due to jaundice, fever, and eosinophilia after Sevoflurane-induced anesthesia.
  • Genetic predisposition known or suspected of malignant hyperthermia.

研究者

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