Perioperative Anaphylaxis in Patients Attending University Hospitals (Egypt - United Kingdom).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- Incidence of suspected perioperative anaphylaxis in an Egyptian population.
研究概览
简要总结
Perioperative anaphylaxis is associated with significant morbidity and mortality. Most textbooks describe it as a rare event of the order of 1 in 10 to 1 in 20,000 general anaesthetic cases. However, a recent study in the United Kingdom suggested that 1 in 350 cases have features suspicious of perioperative anaphylaxis. This study suggests that perioperative anaphylaxis may be under recognised and under reported.
When perioperative anaphylaxis is recognised, it would be ideal to carry out investigations firstly to confirm the diagnosis of anaphylaxis and secondly to identify the causative agent. The latter can be difficult in the context of anaesthesia where the patient is exposed to several drugs and other reagents in a short space of time.
One of the interesting aspects of perioperative anaphylaxis is that there is variability in its epidemiology between different countries, for example between the United Kingdom, France, Scandinavia and Australia and New Zealand. There are currently no data from Egypt to include in such comparisons and to inform clinical practice.
As well as being at risk if a drug allergen is not identified, patients can also be at risk from an incorrect allergy label. The most common example of this is penicillin allergy where fewer than 10% of patients with a history of penicillin allergy are found to be allergic. Incorrect penicillin allergy labels are potentially harmful for patients attending for surgery because the label independently increases the risk of developing infection to resistant organisms, longer hospital stays and mortality.
详细描述
Perioperative anaphylaxis is associated with significant morbidity and mortality. Most textbooks describe it as a rare event of the order of 1 in 10 to 1 in 20,000 general anaesthetic cases. However, a recent study in the United Kingdom suggested that 1 in 350 cases have features suspicious of perioperative anaphylaxis. This study suggests that perioperative anaphylaxis may be under recognised and under reported.
When perioperative anaphylaxis is recognised, it would be ideal to carry out investigations firstly to confirm the diagnosis of anaphylaxis and secondly to identify the causative agent. The latter can be difficult in the context of anaesthesia where the patient is exposed to several drugs and other reagents in a short space of time.
One of the interesting aspects of perioperative anaphylaxis is that there is variability in its epidemiology between different countries, for example between the United Kingdom, France, Scandinavia and Australia and New Zealand. There are currently no data from Egypt to include in such comparisons and to inform clinical practice.
As well as being at risk if a drug allergen is not identified, patients can also be at risk from an incorrect allergy label. The most common example of this is penicillin allergy where fewer than 10% of patients with a history of penicillin allergy are found to be allergic. Incorrect penicillin allergy labels are potentially harmful for patients attending for surgery because the label independently increases the risk of developing infection to resistant organisms, longer hospital stays and mortality.
Aim of the work:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to define the incidence of possible anaphylaxis, data will be collected on 1000 consecutive general anaesthetic procedures in Assiut University Hospitals.
- •A blood cell sample for mast cell tryptase will be taken immediately prior to surgery and 1 hour following induction of anaesthesia in the following groups of patients (n = 30 in each case):
- •(a) Children undergoing elective surgery between the ages of 3 and 10 years (b) Adults between the ages of 16 and 30 years undergoing orthopaedic trauma surgery (c) Adults more than 60 years of age undergoing orthopaedic surgery (d) Women of any age undergoing gynaecological surgery (e) Adults of any age undergoing emergency general surgery (g) Women undergoing caesarean section under general or regional anaesthesia
- •Exclusion criteria:
- •patient refusal, history of previous allergic reaction.
排除标准
- 未提供
结局指标
主要结局
Incidence of suspected perioperative anaphylaxis in an Egyptian population.
时间窗: one year
Snap shot on epidemiology of perioperative hypersensitivity reactions in an Egyptian population
次要结局
- Effect of anaesthesia and surgery on mast cell tryptase(two years)
研究者
Hytham Hussien Kamel Mohamed Shoeib
Principal investigator
Assiut University