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CompletedNCT04839666Updated May 11, 2023

Hypersensitivity Reactions to Propofol in Children

An observational study in Hypersensitivity, Allergy, Egg and Soy Allergy, sponsored by Universitair Ziekenhuis Brussel. Completed at 1 site in Belgium. Open to participants aged Up to 16 Years. Per ClinicalTrials.gov, last updated 2023-05-11.

Primary conditionEgg HypersensitivityRegistry: HypersensitivityReclassifiedWhy we changed it
Registry
Hypersensitivity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Egg Hypersensitivity
Why
  1. The study's listed conditions name Egg Hypersensitivity, a narrower term within Hypersensitivity.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Universitair Ziekenhuis Brussel · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,299
Ages
Up to 16 Years
Sex
All
01

Study summary

The investigators would only include the children who received propofol (Propolipid, Fresenius Kabi, Schelle, Belgium) for sedation, the investigators would exclude the children that didn't receive propofol during the procedure.

The investigators would analyze the incidence of hypersensitivity reaction to propofol in children allergic to egg, soy or both egg and soy and to compare those with the incidence of hypersensitivity reactions in children without allergy to egg and/or to soy. Those data were retrieved following longitudinal follow-up after the intervention. Allergy tests by skin and radioallergosorbent tests were performed in all children before the gastrointestinal endoscopy under anesthesia took place, but no results were known at the time of the sedation. A patient was defined as allergic to egg and/or soy if the patient had specific S-IgE level more than the normal level set by our institution (0.35 kU/L).

The investigators would also investigate the influence of other obtained parameters in the dataset (age, ASA score, weight category, type of investigation, respiratory and neurological comorbidities, respiratory infections, GERD, other allergies) on those results with multivariate analysis.

We considered that clinical features suggesting a hypersensitivity reaction present during anaesthesia were cutaneous, respiratory or cardiovascular manifestations. Depending on the severity of the reaction, necessitating prompt hemodynamic resuscitation with the administration of epinephrine, antihistamines, inhaled beta-agonists or corticosteroids.

02

Conditions studied

  • Hypersensitivity
  • Allergy, Egg
  • Soy Allergy

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03

In context

Egg Hypersensitivity Reclassified

38 studies on the registry are indexed under Egg Hypersensitivity; 9 are open to participants now.

Browse Egg Hypersensitivity studies →

Lead sponsor

Universitair Ziekenhuis Brussel is the lead sponsor of 375 studies on the registry; 107 are open to participants now.

Browse Universitair Ziekenhuis Brussel studies →

Compared within Egg Hypersensitivity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Up to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Children who underwent a surgery in UZ Brussels between the period of 01 January 2010 until 31 August 2016.

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

  • diagnostic gastrointestinal endoscopy
  • monitored anesthesia
  • received propofol during the procedure
  • allergic to egg and/or soy if the patient had specific S-IgE level more than the normal level set by our institution (0.35 kU/L)

Exclusion criteria

Exclusion Criteria:

  • Procedure without administration of propofol
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,299 participants (actual)
Patient registry
No

Groups and cohorts

  • Propofol

    Drug: Propofol

Interventions

  • DrugPropofol

    Perioperatively propofol administration

06

What researchers measure

Primary outcomes

  1. Number of participants with a hypersensitivity reaction

    clinical features suggesting a hypersensitivity reaction present during anaesthesia were cutaneous, respiratory or cardiovascular manifestations.

    Time frame: minutes, during surgery

Secondary outcomes

  1. Influence of gender on hypersensitivity reaction

    See if there is a link or influence of gender on hypersensitivity reaction

    Time frame: minutes, during surgery

  2. Influence of ASA on hypersensitivity reaction

    See if there is a link or influence of ASA on hypersensitivity reaction

    Time frame: minutes, during surgery

  3. Influence of type of procedure on hypersensitivity reaction

    See if there is a link or influence of type of procedure on hypersensitivity reaction

    Time frame: minutes, during surgery

  4. Influence of age on hypersensitivity reaction

    See if there is a link or influence of age on hypersensitivity reaction

    Time frame: minutes, during surgery

  5. Influence of weight on hypersensitivity reaction

    See if there is a link or influence of weight on hypersensitivity reaction

    Time frame: minutes, during surgery

  6. Influence of height on hypersensitivity reaction

    See if there is a link or influence of height on hypersensitivity reaction

    Time frame: minutes, during surgery

  7. Influence of the experience of the gastroenterologist on hypersensitivity reaction

    See if there is a link or influence of experience of gastroenterologist on hypersensitivity reaction

    Time frame: minutes, during surgery

  8. Influence of a respiratory comorbitidity on hypersensitivity reaction

    See if there is a link or influence of respiratory comorbidity on hypersensitivity reaction.

    Time frame: minutes, during surgery

  9. Influence of a neurological comorbidity on hypersensitivity reaction

    See if there is a link or influence of a neurological comorbidity on hypersensitivity reaction

    Time frame: minutes, during surgery

  10. Influence of reason for investigation on hypersensitivity reaction

    See if there is a link or influence of the reason for investigation on hypersensitivity reaction

    Time frame: minutes, during surgery

  11. Influence of a respiratory infection on hypersensitivity reaction

    See if there is a link or influence of a respiratory infection on hypersensitivity reaction.

    Time frame: minutes, during surgery

  12. Influence of GERD on hypersensitivity reaction

    See if there is a link or influence of GERD on hypersensitivity reaction

    Time frame: minutes, during surgery

  13. Influence of an allergy besides egg or soy on hypersensitivity reaction

    See if there is a link or influence of another allergy besides egg or soy on hypersensitivity reaction.

    Time frame: minutes, during surgery

  14. Influence of ketamine on hypersensitivity reaction

    See if there is a link or influence of ketamine on hypersensitivity reaction.

    Time frame: minutes, during surgery

  15. Influence of midazolam on hypersensitivity reaction

    See if there is a link or influence of midazolam on hypersensitivity.

    Time frame: minutes, during surgery

07

Study locations

1 site
  • UZ Brussel
    Jette, Brussel 1090, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2010 to primary completion in Aug 2016, 79 months.

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

Registered
Mar 30, 2021
First posted
Apr 9, 2021
StartActual
Jan 1, 2010
Primary completionActual
Aug 31, 2016
CompletionActual
Aug 31, 2016
Last update
May 11, 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 May 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04839666
Lead sponsor
Universitair Ziekenhuis Brussel
Responsible party
Sponsor
First posted
Apr 9, 2021
Start date
Jan 1, 2010
Primary completion
Aug 31, 2016
Completion
Aug 31, 2016
Last update
May 11, 2023

Oversight

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

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

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