Perioperative Anaphylaxis in Patients Attending University Hospitals (Egypt - UK).

NCT03393091 | Completed

• 1 other identifier: AssiutU222
• Study Type: observational
• Target: 480
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Perioperative/Postoperative Complications; Drug-Induced Anaphylaxis

Outcome Measures

Primary Outcomes (1)

• Incidence of suspected perioperative anaphylaxis in an Egyptian population.

  Snap shot on epidemiology of perioperative hypersensitivity reactions in an Egyptian population

  one year

Secondary Outcomes (1)

• Effect of anaesthesia and surgery on mast cell tryptase

  two years

Study Arms (1)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* 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 previously mentioned groups of patients (n = 30).

You may qualify if:

• 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

You may not qualify if:

• patient refusal, history of previous allergic reaction.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Assiut university hospitals

Asyut, Egypt

Location

Leeds teaching hospitals NHS Trust

Leeds, West Yorkshire, United Kingdom

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hytham Shoeib, MCs,EDA

  Assiut University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 8, 2018
• Study Start: January 15, 2018
• Primary Completion: December 31, 2022
• Study Completion: January 1, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Locations

GB (1); EG (1)