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
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