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

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

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.

Study Overview

• Status: Completed
• Conditions: Perioperative/Postoperative Complications; Drug-Induced Anaphylaxis

Detailed Description

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:

This project proposes the following studies:

1. The incidence of suspected perioperative anaphylaxis in an Egyptian population.
2. Sensitivity and specificity of tryptase changes under surgery and anaesthesia.

Patient and Methods:

1. In order to define the 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.
2. Tryptase is a relatively stable protein released from mast cells alongside histamine during allergic anaphylaxis. Mast cell tryptase is recognised as a useful biomarker for perioperative anaphylaxis but there is debate concerning what degree of change in mast cell tryptase produces the greatest combination of sensitivity and specificity for perioperative anaphylaxis. Variable results from different countries suggest that population specific normal responses may need to be defined.

This study will be conducted 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):

1. Children undergoing elective surgery between the ages of 3 and 10 years
2. Adults between the ages of 16 and 30 years undergoing orthopaedic trauma surgery
3. Adults more than 60 years of age undergoing orthopaedic surgery
4. Women of any age undergoing gynaecological surgery
5. Adults of any age undergoing emergency general surgery
6. Adults undergoing cardiac surgery involving cardiopulmonary bypass (samples will be taken immediately preoperatively, prior to cardiopulmonary bypass and 1 hour after cardiopulmonary bypass)
7. Women undergoing caesarean section under general or regional anaesthesia

• Study Type: Observational
• Enrollment (Actual): 480

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University Hospitals
• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom
      • Leeds Teaching Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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).

Description

Inclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of suspected perioperative anaphylaxis in an Egyptian population.	Snap shot on epidemiology of perioperative hypersensitivity reactions in an Egyptian population	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of anaesthesia and surgery on mast cell tryptase	Study effect of age, sex, anaesthesia, fluid and surgery on mast cell tryptase in control and reaction groups	two years

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Hytham Shoeib, MCs,EDA, Assiut University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: December 28, 2017
• First Submitted That Met QC Criteria: January 5, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Shock; Postoperative Complications; Anaphylaxis
• Other Study ID Numbers: AssiutU222

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No