Primary Objective: To determine for a series of drugs frequently used perioperatively the maximal non irritative concentration in intracutaneous skin testing in healthy volunteers. Secondary Objective(s): To compare the percentage/number of positive…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The maximal concentration of drugs generally used in anaesthesiology that can
be used for intradermal skin tests without eliciting an aspecific (irritative)
response reaction.
Secondary outcome
The percentage/number of positive tests of each drug at each concentration as
judged by two different criteria (ENDA and SFAR).
Background summary
Over 7000 cases of immediate IgE-dependent hypersensitivity reactions caused by
drugs used for anesthesia have been described in the last 25 years. These
reactions can be diagnosed by intracutaneous tests with soluble drugs. However,
not of all drugs is known which concentration can be used for intracutaneous
testing without eliciting an aspecific (irritative) response. The absence of
knowledge about these irritating or non-irritating concentrations limits the
value of this diagnostic procedure.
Therefore, by performing standardised intracutaneous tests with increasing drug
concentrations, this study aims at determining the maximum non-irritative test
concentration of several drugs used in general anaesthesia.
Study objective
Primary Objective: To determine for a series of drugs frequently used
perioperatively the maximal non irritative concentration in intracutaneous skin
testing in healthy volunteers.
Secondary Objective(s): To compare the percentage/number of positive tests for
each drug at each concentration between different scoring methods
Study design
Observational study with invasive measurements
Study burden and risks
The volunteers will visit the outpatient clinic 1-2 times for 1,5-2,5 hours
(phase 1: 2 times max. 2,5 hour; phase 2: 1 time max. 1,5 hour). At the start
of this visit the informed consent is signed. Subjects are tested for
dermographism, and if negative, they will get 20 intradermal skin tests
maximal set on their upper back.
The risk of severe reactions is minimized by excluding volunteers with a
history of (drug) allergic reactions or atopy and by performing the skin test
under close control in a place where all medication needed for treating a
severe reaction is ready for use.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- absence of significant disease
- age * 18 year, * 50 year
- signed informed consent
Exclusion criteria
- Age < 18 year or > 50 year
- Previous general anaesthesia, with the exception of (adeno)tonsillectomie before 2000
- History of drug hypersensitivity
- History of anaphylaxis
- History of seasonal or perennial rhinoconjunctivitis
- Use of antihistamines, corticosteroids, immunosuppressant drugs
- Positive dermographism
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43023.018.12 |