Testing drug reactions in patients with perioperative hypersensitivity
Standardised Drug Provocation Testing in Perioperative Hypersensitivity
This study is testing a new way to safely find out which anesthetics might cause allergic reactions in adults who have had bad reactions to anesthesia in the past.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem, Antwerp) |
| Trial ID | NCT06065137 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and outcomes of systematic drug provocation testing (DPT) using anesthetics in adult patients who have experienced perioperative hypersensitivity reactions. The study will involve challenging patients with full doses of various anesthetics after they have undergone negative conventional testing to identify any potential drug culprits. By establishing the negative predictive value of conventional testing, the trial seeks to improve the safety of future anesthetic procedures for these patients. The approach is designed to address the challenges of identifying the specific drugs responsible for hypersensitivity reactions, which can be masked during surgery.
Who should consider this trial
Good fit: Ideal candidates are adult patients referred for diagnostic work-up for perioperative hypersensitivity with a relevant clinical history.
Not a fit: Patients who refuse participation or have an incomplete diagnostic work-up will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety of anesthetic practices for patients with a history of perioperative hypersensitivity.
How similar studies have performed: While conventional testing has shown predictive value, this prospective approach to drug provocation testing is novel and aims to provide more definitive results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients consulting the allergology department of the Antwerp University hospital medical with a history consistent with perioperative hypersensitivity * Indication for diagnostic work-up as determined at an interdisciplinary meeting between allergologists and anaesthetists * willing to sign separate informed consent forms for both general anaesthesia and the Drug Provocation Test. Exclusion Criteria: * patient refusal * incomplete diagnostic work-up * history inconsistent with perioperative hypersensitivity
Where this trial is running
Edegem, Antwerp
- Antwerp University Hospital — Edegem, Antwerp, Belgium (Recruiting)
Study contacts
- Principal investigator: Vera Saldien, MD,PhD — University Hospital Antwerp, Head of department of anesthesiology
- Study coordinator: Nils Vlaeminck, MD
- Email: nils.vlaeminck@uza.be
- Phone: 038215865
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.