Hypersensitivity Reactions to Propofol in Children

Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04839666
• Other study ID #: 2021-
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: August 31, 2016

Study information

• Verified date: May 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2299
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergy, Egg
• Egg Hypersensitivity
• Hypersensitivity
• Soy Allergy

Intervention

Drug:
• Propofol
Perioperatively propofol administration

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with a hypersensitivity reaction	clinical features suggesting a hypersensitivity reaction present during anaesthesia were cutaneous, respiratory or cardiovascular manifestations.	minutes, during surgery
Secondary	Influence of gender on hypersensitivity reaction	See if there is a link or influence of gender on hypersensitivity reaction	minutes, during surgery
Secondary	Influence of ASA on hypersensitivity reaction	See if there is a link or influence of ASA on hypersensitivity reaction	minutes, during surgery
Secondary	Influence of type of procedure on hypersensitivity reaction	See if there is a link or influence of type of procedure on hypersensitivity reaction	minutes, during surgery
Secondary	Influence of age on hypersensitivity reaction	See if there is a link or influence of age on hypersensitivity reaction	minutes, during surgery
Secondary	Influence of weight on hypersensitivity reaction	See if there is a link or influence of weight on hypersensitivity reaction	minutes, during surgery
Secondary	Influence of height on hypersensitivity reaction	See if there is a link or influence of height on hypersensitivity reaction	minutes, during surgery
Secondary	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	minutes, during surgery
Secondary	Influence of a respiratory comorbitidity on hypersensitivity reaction	See if there is a link or influence of respiratory comorbidity on hypersensitivity reaction.	minutes, during surgery
Secondary	Influence of a neurological comorbidity on hypersensitivity reaction	See if there is a link or influence of a neurological comorbidity on hypersensitivity reaction	minutes, during surgery
Secondary	Influence of reason for investigation on hypersensitivity reaction	See if there is a link or influence of the reason for investigation on hypersensitivity reaction	minutes, during surgery
Secondary	Influence of a respiratory infection on hypersensitivity reaction	See if there is a link or influence of a respiratory infection on hypersensitivity reaction.	minutes, during surgery
Secondary	Influence of GERD on hypersensitivity reaction	See if there is a link or influence of GERD on hypersensitivity reaction	minutes, during surgery
Secondary	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.	minutes, during surgery
Secondary	Influence of ketamine on hypersensitivity reaction	See if there is a link or influence of ketamine on hypersensitivity reaction.	minutes, during surgery
Secondary	Influence of midazolam on hypersensitivity reaction	See if there is a link or influence of midazolam on hypersensitivity.	minutes, during surgery