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临床试验/EUCTR2013-000476-14-SE
EUCTR2013-000476-14-SE进行中(未招募)1 期

TARGET-CONTROLLED INFUSION (TCI) WITH PROPOFOL AND REMIFENTANIL AS ANALGO-SEDATION IN WOUND CARE IN PATIENTS WITH BURNS - TCI BRIVA

ANDSTINGET I ÖSTERGÖTLAND0 个研究点目标入组 80 人开始时间: 2013年3月19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
入组人数
80

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

  • Adult patients (= 18 years) with burns regardless degree or extent.
  • The patient should be hospitalized in a swedish burn center.
  • The subject is planned for at least two consecutive occasions with wound care with analgo-sedation.
  • The patient has given their consent to participate in the study.
  • 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 60
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • Patients who are ventilator treated.
  • Mental or physical inability, unwillingness or language difficulties that causes difficulty to understand the meaning of participation in the study, according to the responsible physician.
  • Wound care where bath is planned.
  • Contraindications to study drug:
  • Known or suspected allergy or hypersensitivity to oxycodone, propofol, remifentanil, morphine, selective 5-HT3 receptor antagonists, fentanyl analog, opioids, pregabalin, paracetamol, naproxen, peanuts or soy.
  • Respiratory depression with or without hypoxia, hypercapnia, severe bronchial asthma patients who have had symptoms of asthma, rhinitis or urticaria after taking aspirin or other anti-inflammatory agents of non-steroidal nature, severe chronic obstructive pulmonary disease and cor pulmonale.
  • Severe heart failure, hypovolemia and hypotension.
  • Increased intracranial pressure or head injury.
  • Myasthenia gravis.
  • Conditions associated with increased bleeding, an ongoing or history of gastrointestinal bleeding or perforation.
  • Cirrhosis of the liver.
  • Kidney disease (glomerular filtration rate <30 ml / min).
  • Paralytic ileus.
  • Third trimester of pregnancy and during lactation.
  • Concomitant use with MAO inhibitors or recent (within two weeks) discontinuation of MAO inhibitors.

研究者

发起方
ANDSTINGET I ÖSTERGÖTLAND

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