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临床试验/NCT04839666
NCT04839666已完成不适用

Incidence of Perioperative Hypersensitivity Reactions to Propofol in Children Allergic to Egg and/or Soy

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 2,299 人开始时间: 2010年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
2,299
试验地点
1
主要终点
Number of participants with a hypersensitivity reaction

研究概览

简要总结

The investigators would only include the children who received propofol (Propolipid, Fresenius Kabi, Schelle, Belgium) for sedation, the investigators would exclude the children that didn't receive propofol during the procedure.

The investigators would analyze the incidence of hypersensitivity reaction to propofol in children allergic to egg, soy or both egg and soy and to compare those with the incidence of hypersensitivity reactions in children without allergy to egg and/or to soy. Those data were retrieved following longitudinal follow-up after the intervention. Allergy tests by skin and radioallergosorbent tests were performed in all children before the gastrointestinal endoscopy under anesthesia took place, but no results were known at the time of the sedation. A patient was defined as allergic to egg and/or soy if the patient had specific S-IgE level more than the normal level set by our institution (0.35 kU/L).

The investigators would also investigate the influence of other obtained parameters in the dataset (age, ASA score, weight category, type of investigation, respiratory and neurological comorbidities, respiratory infections, GERD, other allergies) on those results with multivariate analysis.

We considered that clinical features suggesting a hypersensitivity reaction present during anaesthesia were cutaneous, respiratory or cardiovascular manifestations. Depending on the severity of the reaction, necessitating prompt hemodynamic resuscitation with the administration of epinephrine, antihistamines, inhaled beta-agonists or corticosteroids.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • diagnostic gastrointestinal endoscopy
  • monitored anesthesia
  • received propofol during the procedure
  • allergic to egg and/or soy if the patient had specific S-IgE level more than the normal level set by our institution (0.35 kU/L)

排除标准

  • Procedure without administration of propofol

研究组 & 干预措施

Propofol

干预措施: Propofol (Drug)

结局指标

主要结局

Number of participants with a hypersensitivity reaction

时间窗: minutes, during surgery

clinical features suggesting a hypersensitivity reaction present during anaesthesia were cutaneous, respiratory or cardiovascular manifestations.

次要结局

  • Influence of a neurological comorbidity on hypersensitivity reaction(minutes, during surgery)
  • Influence of reason for investigation on hypersensitivity reaction(minutes, during surgery)
  • Influence of GERD on hypersensitivity reaction(minutes, during surgery)
  • Influence of weight on hypersensitivity reaction(minutes, during surgery)
  • Influence of height on hypersensitivity reaction(minutes, during surgery)
  • Influence of ASA on hypersensitivity reaction(minutes, during surgery)
  • Influence of type of procedure on hypersensitivity reaction(minutes, during surgery)
  • Influence of ketamine on hypersensitivity reaction(minutes, during surgery)
  • Influence of gender on hypersensitivity reaction(minutes, during surgery)
  • Influence of age on hypersensitivity reaction(minutes, during surgery)
  • Influence of a respiratory comorbitidity on hypersensitivity reaction(minutes, during surgery)
  • Influence of the experience of the gastroenterologist on hypersensitivity reaction(minutes, during surgery)
  • Influence of a respiratory infection on hypersensitivity reaction(minutes, during surgery)
  • Influence of an allergy besides egg or soy on hypersensitivity reaction(minutes, during surgery)
  • Influence of midazolam on hypersensitivity reaction(minutes, during surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Hypersensitivity Reactions to Propofol in Children | 临床试验