HypersensitivityNCT04839666
Hypersensitivity Reactions to Propofol in Children
An observational study of Hypersensitivity and Allergy, Egg, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Hypersensitivity, Allergy, Egg, Soy Allergy
- What is being tested?
- Propofol
- How many people
- 2,299 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2010to 31 Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children who underwent a surgery in UZ Brussels between the period of 01 January 2010 until 31 August 2016.
Who may be able to join
- 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)
Who cannot join
- Procedure without administration of propofol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Perioperative Hypersensitivity Reactions to Propofol in Children Allergic to Egg and/or Soy
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).
Read more
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.
- Conditions
- Hypersensitivity, Allergy, Egg, Soy Allergy
- Being tested
- Propofol
- Medical subject headings
- Hypersensitivity, Egg Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Perioperatively propofol administration
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a hypersensitivity reaction
clinical features suggesting a hypersensitivity reaction present during anaesthesia were cutaneous, respiratory or cardiovascular manifestations.
Measured: minutes, during surgery
Secondary outcomes (15)
Influence of gender on hypersensitivity reaction
See if there is a link or influence of gender on hypersensitivity reaction
Measured: minutes, during surgery
Influence of ASA on hypersensitivity reaction
See if there is a link or influence of ASA on hypersensitivity reaction
Measured: minutes, during surgery
Influence of type of procedure on hypersensitivity reaction
See if there is a link or influence of type of procedure on hypersensitivity reaction
Measured: minutes, during surgery
Influence of age on hypersensitivity reaction
See if there is a link or influence of age on hypersensitivity reaction
Measured: minutes, during surgery
Influence of weight on hypersensitivity reaction
See if there is a link or influence of weight on hypersensitivity reaction
Measured: minutes, during surgery
Influence of height on hypersensitivity reaction
See if there is a link or influence of height on hypersensitivity reaction
Measured: minutes, during surgery
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
Measured: minutes, during surgery
Influence of a respiratory comorbitidity on hypersensitivity reaction
See if there is a link or influence of respiratory comorbidity on hypersensitivity reaction.
Measured: minutes, during surgery
Influence of a neurological comorbidity on hypersensitivity reaction
See if there is a link or influence of a neurological comorbidity on hypersensitivity reaction
Measured: minutes, during surgery
Influence of reason for investigation on hypersensitivity reaction
See if there is a link or influence of the reason for investigation on hypersensitivity reaction
Measured: minutes, during surgery
Influence of a respiratory infection on hypersensitivity reaction
See if there is a link or influence of a respiratory infection on hypersensitivity reaction.
Measured: minutes, during surgery
Influence of GERD on hypersensitivity reaction
See if there is a link or influence of GERD on hypersensitivity reaction
Measured: minutes, during surgery
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.
Measured: minutes, during surgery
Influence of ketamine on hypersensitivity reaction
See if there is a link or influence of ketamine on hypersensitivity reaction.
Measured: minutes, during surgery
Influence of midazolam on hypersensitivity reaction
See if there is a link or influence of midazolam on hypersensitivity.
Measured: minutes, during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Jan 2010
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839666
- Sponsor's protocol ID
- 2021-
- Status last verified
- May 2023
- First submitted
- 30 Mar 2021
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Perioperative Hypersensitivity Reactions to Propofol in Children Allergic to Egg and/or Soy
- ClinicalTrials.gov ID
- NCT04839666
- Acronym / sponsor ID
- 2021-
- Conditions
- Hypersensitivity, Allergy, Egg, Soy Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,299 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propofol | – | Drug: Propofol |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children who underwent a surgery in UZ Brussels between the period of 01 January 2010 until 31 August 2016.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Procedure without administration of propofol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolPerioperatively propofol administration | Drug | Propofol |
Primary outcome
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.
15 secondary outcomes
Influence of gender on hypersensitivity reaction
Time frame: minutes, during surgery
Influence of ASA on hypersensitivity reaction
Time frame: minutes, during surgery
Influence of type of procedure on hypersensitivity reaction
Time frame: minutes, during surgery
Influence of age on hypersensitivity reaction
Time frame: minutes, during surgery
Influence of weight on hypersensitivity reaction
Time frame: minutes, during surgery
Influence of height on hypersensitivity reaction
Time frame: minutes, during surgery
Influence of the experience of the gastroenterologist on hypersensitivity reaction
Time frame: minutes, during surgery
Influence of a respiratory comorbitidity on hypersensitivity reaction
Time frame: minutes, during surgery
Influence of a neurological comorbidity on hypersensitivity reaction
Time frame: minutes, during surgery
Influence of reason for investigation on hypersensitivity reaction
Time frame: minutes, during surgery
Influence of a respiratory infection on hypersensitivity reaction
Time frame: minutes, during surgery
Influence of GERD on hypersensitivity reaction
Time frame: minutes, during surgery
Influence of an allergy besides egg or soy on hypersensitivity reaction
Time frame: minutes, during surgery
Influence of ketamine on hypersensitivity reaction
Time frame: minutes, during surgery
Influence of midazolam on hypersensitivity reaction
Time frame: minutes, during surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypersensitivity and Allergy, Egg, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a hypersensitivity reaction (time frame: minutes, during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.