NCT06065137

Brief Summary

The goal of this clinical trial is to evaluate the safety and outcome of systematic drug provocation testing with anaesthetics at therapeutic doses in adult patients undergoing diagnostic work-up for perioperative hypersensitivity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

October 23, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

1.7 years

First QC Date

September 19, 2023

Last Update Submit

September 1, 2025

Conditions

Allergic ReactionHypersensitivityPerioperative ComplicationAnaphylaxisAnaphylactic ReactionImmediate HypersensitivityHypersensitivity, Drug

Outcome Measures

Primary Outcomes (1)

  • Hypersensitivity during DPT

    Prevalence of hypersensitivity during direct provocation for drugs that tested negatively in conventional tests.

    1 hour

Secondary Outcomes (3)

  • Severe reactions during DPT

    1 hour

  • Adverse events during DPT

    1 hour

  • Sensitivity of conventional tests

    1 hour

Study Arms (1)

POH patients

EXPERIMENTAL

incremental administration of investigated anesthetics up to full therapeutic dose in POH patients.

Diagnostic Test: Full dose DPT with propofolDiagnostic Test: Full dose DPT with ketamineDiagnostic Test: Full dose DPT with etomidateDiagnostic Test: Full dose DPT with midazolamDiagnostic Test: Full dose DPT with fentanylDiagnostic Test: Full dose DPT with sufentanylDiagnostic Test: Full dose DPT with alfentanilDiagnostic Test: Full dose DPT with remifentanilDiagnostic Test: Full dose DPT with rocuroniumDiagnostic Test: Full dose DPT with atracuriumDiagnostic Test: Full dose DPT with cisatracuriumDiagnostic Test: Full dose DPT with succinylcholine

Interventions

Full dose DPT with propofolDIAGNOSTIC_TEST

Incremental administration of propofol up to a cummulative full therapeutic dose (2mg/kg) in POH patients investigated for propofol. Doses will be administered every 15 minutes starting at 1/100th of the dose, followed by 1/10th of the dose, 3/10th of the dose and ultimately 6/10th of the dose (0.02mg/kg-0.2 mg/kg -0.6 mg/kg -1.2mg/kg).

POH patients
Full dose DPT with ketamineDIAGNOSTIC_TEST

Incremental administration of ketamine up to a cummulative full therapeutic dose (1mg/kg) in POH patients investigated for ketamine. Doses will be administered every 15 minutes starting at 1/100th of the dose, followed by 1/10th of the dose, 3/10th of the dose and ultimately 6/10th of the dose (0.01 mg/kg -0.1 mg/kg -0.3 mg/kg -0.6mg/kg).

POH patients
Full dose DPT with etomidateDIAGNOSTIC_TEST

Incremental administration of etomidate up to a cummulative full therapeutic dose (0.2mg/kg) in POH patients investigated for etomidate. Doses will be administered every 15 minutes starting at 1/100th of the dose, followed by 1/10th of the dose, 3/10th of the dose and ultimately 6/10th of the dose (0.002 mg/kg -0.02 mg/kg -0.06 mg/kg -1.2mg/kg).

POH patients
Full dose DPT with midazolamDIAGNOSTIC_TEST

Incremental administration of midazolam up to a cummulative full therapeutic dose (0.05mg/kg) in POH patients investigated for midazolam. Doses will be administered every 15 minutes starting at 1/100th of the dose, followed by 1/10th of the dose, 3/10th of the dose and ultimately 6/10th of the dose (0.0005 mg/kg -0.005 mg/kg -0.015 mg/kg -0.03mg/kg).

POH patients
Full dose DPT with fentanylDIAGNOSTIC_TEST

Incremental administration of fentanyl up to a cummulative full therapeutic dose (1mcg/kg) in POH patients investigated for fentanyl. Doses will be administered every 15 minutes starting at 1/100th of the dose, followed by 1/10th of the dose, 3/10th of the dose and ultimately 6/10th of the dose (0.01 mcg/kg -0.1 mcg/kg -0.3 mcg/kg -0.6mcg/kg).

POH patients
Full dose DPT with sufentanylDIAGNOSTIC_TEST

Incremental administration of sufentanyl up to a cummulative full therapeutic dose (0.1mcg/kg) in POH patients investigated for sufentanyl. Doses will be administered every 15 minutes starting at 1/100th of the dose, followed by 1/10th of the dose, 3/10th of the dose and ultimately 6/10th of the dose (0.001 mcg/kg -0.01 mcg/kg -0.03 mcg/kg -0.06µg/kg).

POH patients
Full dose DPT with alfentanilDIAGNOSTIC_TEST

Incremental administration of alfentanil up to a cummulative full therapeutic dose (10mcg/kg) in POH patients investigated for alfentanil. Doses will be administered every 15 minutes starting at 1/100th of the dose, followed by 1/10th of the dose, 3/10th of the dose and ultimately 6/10th of the dose (0.1 mcg/kg -1 mcg/kg -3 mcg/kg -6µg/kg).

POH patients
Full dose DPT with remifentanilDIAGNOSTIC_TEST

Incremental administration of remifentanil up to a cummulative full therapeutic dose (0.5mcg/kg) in POH patients investigated for remifentanil. Doses will be administered every 15 minutes starting at 1/100th of the dose, followed by 1/10th of the dose, 3/10th of the dose and ultimately 6/10th of the dose (0.005 mcg/kg -0.05 mcg/kg -0.15 mcg/kg -0.3µg/kg).

POH patients
Full dose DPT with rocuroniumDIAGNOSTIC_TEST

Incremental administration of rocuronium up to a cummulative full therapeutic dose (0.6mg/kg) in POH patients investigated for rocuronium. Doses will be administered every 15 minutes starting at 1/100th of the dose, followed by 1/10th of the dose (0.006 mg/kg -0.06 mg/kg ). In a second session 3/10th of the dose and ultimately 7/10th of the dose (0.18 mg/kg -0.42mg/kg) are administerd under general anesthesia.

POH patients
Full dose DPT with atracuriumDIAGNOSTIC_TEST

Incremental administration of atracurium up to a cummulative full therapeutic dose (0.5mg/kg) in POH patients investigated for atracurium. Doses will be administered every 15 minutes starting at 1/100th of the dose, followed by 1/10th of the dose (0.005 mg/kg -0.05 mg/kg ). In a second session 3/10th of the dose and ultimately 7/10th of the dose (0.15 mg/kg -0.35mg/kg) are administered under general anesthesia .

POH patients
Full dose DPT with cisatracuriumDIAGNOSTIC_TEST

Incremental administration of cisatracurium up to a cummulative full therapeutic dose (0.15mg/kg) in POH patients investigated for cisatracurium. Doses will be administered every 15 minutes starting at 1/100th of the dose, followed by 1/10th of the dose (0.0015 mg/kg -0.015 mg/kg ). In a second session 3/10th of the dose and ultimately 7/10th of the dose (0.045 mg/kg -0.105mg/kg) are administered under general anesthesia .

POH patients
Full dose DPT with succinylcholineDIAGNOSTIC_TEST

Incremental administration of succinylcholine up to a cummulative full therapeutic dose (1mg/kg) in POH patients investigated for succinylcholine. Doses will be administered every 15 minutes starting at 1/100th of the dose, followed by 1/10th of the dose (0.01 mg/kg -0.1 mg/kg). In a second session 3/10th of the dose and ultimately 7/10th of the dose (0.3 mg/kg -0.7mg/kg) are administered under general anesthesia.

POH patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • patient refusal
  • incomplete diagnostic work-up
  • history inconsistent with perioperative hypersensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

HypersensitivityAnaphylaxisHypersensitivity, ImmediateDrug Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System DiseasesDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Officials

  • Vera Saldien, MD,PhD

    University Hospital Antwerp, Head of department of anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2023

First Posted

October 3, 2023

Study Start

October 23, 2023

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

September 8, 2025

Record last verified: 2025-08

Locations

BE(1)