Perioperative Anaphylaxis in an Egyptian Population.
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|ClinicalTrials.gov Identifier: NCT03393091|
Recruitment Status : Unknown
Verified April 2018 by Hytham Hussien Kamel Mohamed Shoeib, Assiut University.
Recruitment status was: Recruiting
First Posted : January 8, 2018
Last Update Posted : April 19, 2018
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.
|Condition or disease|
|Perioperative/Postoperative Complications Drug-Induced Anaphylaxis|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Perioperative Anaphylaxis in Egypt (In Assiut University Hospitals).|
|Actual Study Start Date :||January 15, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||January 1, 2020|
Incidence of possible anaphylaxis
Data will be collected on 1000 consecutive general anaesthetic procedures in Assiut University Hospitals. After each elective operating list the anaesthetist will be asked to complete a form in which they will document the number of patients receiving general anaesthesia on the list and the number of those patients who developed any of the following features: unexpected, unexplained hypotension; unexpected bronchospasm resistant to treatment; angioedema; urticaria; severe itching; widespread erythema
- Incidence of suspected perioperative anaphylaxis in an Egyptian population. [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393091
|Contact: Hytham Shoeibfirstname.lastname@example.org|
|Assiut university hospitals||Recruiting|
|Contact: Hytham Shoeib|