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