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NCT04046731 Clinical Trial

Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation

Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04046731
Other study ID # 18-007462
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2019
Est. completion date December 31, 2021

Study information
Verified date February 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 187
Est. completion date December 31, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Skin Testing
Percutaneous skin prick followed by Intradermal Injections of NMBAs at increasing concentrations compared with an established positive and negative control.

Locations
Country Name City State
United States Mayo Clinic Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Non-Irritant Concentrations to common NMBAs Determine the NIC to common NMBAs 1 Year
Secondary Negative Predictive Value of Intradermal Skin Testing to commonly used NMBAs Determine Negative Predictive Value of Intradermal Skin Testing to commonly used NMBAs 1 Year
Secondary Max Concentration used when skin testing to NMBAs Close gap on the variability of the maximal concentration used when skin testing NMBAs. 1 Year
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