Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation

February 1, 2022 updated by: Alexei Gonzalez-Estrada, MD, Mayo Clinic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

187

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
Study team is developing a new diagnostic skin testing procedure for patients who receive NMBAs during surgery in order to determine Negative Predictive Values and Non-Irritant Concentrations.
Diagnostic test: Skin Testing
Percutaneous skin prick followed by Intradermal Injections of NMBAs at increasing concentrations compared with an established positive and negative control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-Irritant Concentrations to common NMBAs
Time Frame: 1 Year
Determine the NIC to common NMBAs
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative Predictive Value of Intradermal Skin Testing to commonly used NMBAs
Time Frame: 1 Year
Determine Negative Predictive Value of Intradermal Skin Testing to commonly used NMBAs
1 Year
Max Concentration used when skin testing to NMBAs
Time Frame: 1 Year
Close gap on the variability of the maximal concentration used when skin testing NMBAs.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Alexei Gonzalez Estrada, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2019

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

August 5, 2019

First Submitted That Met QC Criteria

August 5, 2019

First Posted (Actual)

August 6, 2019

Study Record Updates

Last Update Posted (Actual)

February 2, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-007462

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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