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Completed

NCT Number: NCT04839666

Hypersensitivity Reactions to Propofol in Children

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.

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Key information

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Procedure without administration of propofol

Treatment and study plan

Propofol

Drug

Perioperatively propofol administration

Primary outcomes

  1. Number of participants with a hypersensitivity reaction

    Time frame: minutes, during surgery

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

Secondary outcomes

  1. Influence of gender on hypersensitivity reaction

    Time frame: minutes, during surgery

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

  2. Influence of ASA on hypersensitivity reaction

    Time frame: minutes, during surgery

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

  3. Influence of type of procedure on hypersensitivity reaction

    Time frame: minutes, during surgery

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

  4. Influence of age on hypersensitivity reaction

    Time frame: minutes, during surgery

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

  5. Influence of weight on hypersensitivity reaction

    Time frame: minutes, during surgery

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

  6. Influence of height on hypersensitivity reaction

    Time frame: minutes, during surgery

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

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

    Time frame: minutes, during surgery

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

  8. Influence of a respiratory comorbitidity on hypersensitivity reaction

    Time frame: minutes, during surgery

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

  9. Influence of a neurological comorbidity on hypersensitivity reaction

    Time frame: minutes, during surgery

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

  10. Influence of reason for investigation on hypersensitivity reaction

    Time frame: minutes, during surgery

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

  11. Influence of a respiratory infection on hypersensitivity reaction

    Time frame: minutes, during surgery

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

  12. Influence of GERD on hypersensitivity reaction

    Time frame: minutes, during surgery

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

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

    Time frame: minutes, during surgery

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

  14. Influence of ketamine on hypersensitivity reaction

    Time frame: minutes, during surgery

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

  15. Influence of midazolam on hypersensitivity reaction

    Time frame: minutes, during surgery

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

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

Incidence of Perioperative Hypersensitivity Reactions to Propofol in Children Allergic to Egg and/or Soy

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Apr 9, 2021
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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