EUCTR2018-004300-19-FR进行中（未招募）1 期
Target-controled infusion with propofol in the Emergency Department : a prospective study on 50 adult patients - SIVOC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- CHU DE NICE
- 入组人数
- 50
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
入选标准
- •Age of 18 or more
- •Affiliated or beneficiary of a French health insurance system
- •Indication of procedural sedation by the emergency department physician in the context of the management of a patient with an orthopedic lesion requiring a potentially painful emergency therapeutic action (reduction of a joint dislocation or realignment of a limb displaced fracture)
- •Signed free informed consent or inclusion in the context of an emergency situation
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Patient of more than 18 under legal protection or deprivation of liberty measures
- •Ongoing pregnancy or breastfeeding women
- •Patient with the incapacity to give his free informed consent, excepted if the incapacity is induced by the context of the emergency situation (inclusion in the context of an emergency situation)
- •Known hypersensitivity to propofol or one of the excipients, egg, soja or peanuts
- •ASA comorbidity score of 4 or more
- •Heart, respiratory, renal or hepatic failure
- •Lipid metabolism disorder
- •Mitochondrial disease
- •Hemodynamic instability, multiple traumatism
- •Elevated intracranial tension
- •Drug or alcohol intoxication
研究者
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