Hypersensitivity Reactions to Propofol in Children

Completed

• Conditions: Hypersensitivity; Soy Allergy; Allergy, Egg
• Interventions: Drug: Propofol

• Registration Number: NCT04839666
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2016-08-31
• Study Completion: 2016-08-31
• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-09
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2299

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	-

Primary Outcome Measures

Name	Time	Method
Number of participants with a hypersensitivity reaction	minutes, during surgery	clinical features suggesting a hypersensitivity reaction present during anaesthesia were cutaneous, respiratory or cardiovascular manifestations.

Secondary Outcome Measures

Name	Time	Method
Influence of a neurological comorbidity on hypersensitivity reaction	minutes, during surgery	See if there is a link or influence of a neurological comorbidity on hypersensitivity reaction
Influence of reason for investigation on hypersensitivity reaction	minutes, during surgery	See if there is a link or influence of the reason for investigation on hypersensitivity reaction
Influence of GERD on hypersensitivity reaction	minutes, during surgery	See if there is a link or influence of GERD on hypersensitivity reaction
Influence of weight on hypersensitivity reaction	minutes, during surgery	See if there is a link or influence of weight on hypersensitivity reaction
Influence of height on hypersensitivity reaction	minutes, during surgery	See if there is a link or influence of height on hypersensitivity reaction
Influence of ASA on hypersensitivity reaction	minutes, during surgery	See if there is a link or influence of ASA on hypersensitivity reaction
Influence of type of procedure on hypersensitivity reaction	minutes, during surgery	See if there is a link or influence of type of procedure on hypersensitivity reaction
Influence of ketamine on hypersensitivity reaction	minutes, during surgery	See if there is a link or influence of ketamine on hypersensitivity reaction.
Influence of gender on hypersensitivity reaction	minutes, during surgery	See if there is a link or influence of gender on hypersensitivity reaction
Influence of age on hypersensitivity reaction	minutes, during surgery	See if there is a link or influence of age on hypersensitivity reaction
Influence of a respiratory comorbitidity on hypersensitivity reaction	minutes, during surgery	See if there is a link or influence of respiratory comorbidity on hypersensitivity reaction.
Influence of the experience of the gastroenterologist on hypersensitivity reaction	minutes, during surgery	See if there is a link or influence of experience of gastroenterologist on hypersensitivity reaction
Influence of a respiratory infection on hypersensitivity reaction	minutes, during surgery	See if there is a link or influence of a respiratory infection on hypersensitivity reaction.
Influence of an allergy besides egg or soy on hypersensitivity reaction	minutes, during surgery	See if there is a link or influence of another allergy besides egg or soy on hypersensitivity reaction.
Influence of midazolam on hypersensitivity reaction	minutes, during surgery	See if there is a link or influence of midazolam on hypersensitivity.

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Brussel, Belgium