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CompletedNCT03393091Updated Dec 29, 2023

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

An observational study in Perioperative/Postoperative Complications and Drug-Induced Anaphylaxis, sponsored by Assiut University. Completed at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2023-12-29.

Sponsored by Assiut University · Observational

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
480
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 10 studies in Postoperative Complications by Assiut University — 5 open to participants now, 5 under way, none of them phase 3. Postoperative Complications · Assiut University.

Started
2018
the only one that year
Observational
4 of 10
1 open now
Registered
2nd of 10
by date

Among the 10 studies in Postoperative Complications by Assiut University, this one is the only one that started in 2018, is one of 4 observational ones, and was the 2nd registered.

Postoperative Complications

1,335 studies on the registry are indexed under Postoperative Complications; 310 are open to participants now.

Browse Postoperative Complications studies →

Open to participants now

5 of the 10 studies in Postoperative Complications by Assiut University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 201 Postoperative Complications studies recruiting now, 125 (62%) set no upper age limit and 32 (16%) stop at 75 or younger; 25 take children under 18; 25 take healthy volunteers.

This study: all sexes · healthy volunteers too.

The full table on the hub →

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02

Study 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.

Read the 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
03

Conditions studied

  • Perioperative/Postoperative Complications
  • Drug-Induced Anaphylaxis
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria:

patient refusal, history of previous allergic reaction.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
480 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Incidence of suspected perioperative anaphylaxis in an Egyptian population.

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

    Time frame: one year

Secondary outcomes

  1. 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

    Time frame: two years

07

Study locations

2 sites
  • Assiut university hospitals
    Assiut, Egypt
  • Leeds teaching hospitals NHS Trust
    Leeds, West Yorkshire, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Dec 2022, 59 months.

Of 276 non-industry observational studies under Postoperative Complications, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's 59 months is above that.

Counting every sponsor, half of 281 studies reached it within 22 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 28, 2017
First posted
Jan 8, 2018
StartActual
Jan 15, 2018
Primary completionActual
Dec 31, 2022
CompletionActual
Jan 1, 2023
Last update
Dec 29, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03393091
Lead sponsor
Assiut University
Responsible party
Hytham Hussien Kamel Mohamed Shoeib (Principal investigator, Assiut University) — Principal investigator
First posted
Jan 8, 2018
Start date
Jan 15, 2018
Primary completion
Dec 31, 2022
Completion
Jan 1, 2023
Last update
Dec 29, 2023

Study contacts

Hytham Shoeib, MCs,EDA
principal investigator · Assiut University Hospitals

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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