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Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation

The Negative Predictive Value and Non-irritant Skin Testing Concentrations of Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04046731
Enrollment
187
Registered
2019-08-06
Start date
2019-09-20
Completion date
2021-12-31
Last updated
2022-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

Brief summary

The researchers are trying to develop an allergy skin test to help predict allergic responses to medications commonly given to patients during surgery.

Detailed description

This study will be a prospective study to accurately determine the negative predictive value of skin testing with NMBAs. It is hypothesized that the concentrations that should be used for NMBAs are actually much lower than previously recommended and that the higher incidence of identifiable NMBA induced allergic reactions during anesthesia in the past may be due to irritation of the skin rather than a true allergic reaction (false positives).

Interventions

DIAGNOSTIC_TESTSkin Testing

Percutaneous skin prick followed by Intradermal Injections of NMBAs at increasing concentrations compared with an established positive and negative control.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All adults \> or = to 18 y/o undergoing surgery

Exclusion criteria

* Minors under the age of 18 y/o, Adults unable to consent, or those Adults with previous allergic reaction history during previous surgeries.

Design outcomes

Primary

MeasureTime frameDescription
Non-Irritant Concentrations to common NMBAs1 YearDetermine the NIC to common NMBAs

Secondary

MeasureTime frameDescription
Negative Predictive Value of Intradermal Skin Testing to commonly used NMBAs1 YearDetermine Negative Predictive Value of Intradermal Skin Testing to commonly used NMBAs
Max Concentration used when skin testing to NMBAs1 YearClose gap on the variability of the maximal concentration used when skin testing NMBAs.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026