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Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation

Primary Purpose

Allergy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Skin Testing

About this trial

This is an interventional diagnostic trial for Allergy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Non-Irritant Concentrations to common NMBAs

Determine the NIC to common NMBAs

Secondary Outcome Measures

Negative Predictive Value of Intradermal Skin Testing to commonly used NMBAs

Determine Negative Predictive Value of Intradermal Skin Testing to commonly used NMBAs

Max Concentration used when skin testing to NMBAs

Close gap on the variability of the maximal concentration used when skin testing NMBAs.

Full Information

NCT ID

NCT04046731

First Posted

August 5, 2019

Last Updated

February 1, 2022

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04046731

Brief Title

Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

September 20, 2019 (Actual)

Primary Completion Date

December 30, 2021 (Actual)

Study Completion Date

December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

187 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Group

Arm Type

Experimental

Arm Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Skin Testing

Intervention Description

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

Primary Outcome Measure Information:

Title

Non-Irritant Concentrations to common NMBAs

Description

Determine the NIC to common NMBAs

Time Frame

1 Year

Secondary Outcome Measure Information:

Title

Negative Predictive Value of Intradermal Skin Testing to commonly used NMBAs

Description

Determine Negative Predictive Value of Intradermal Skin Testing to commonly used NMBAs

Time Frame

1 Year

Title

Max Concentration used when skin testing to NMBAs

Description

Close gap on the variability of the maximal concentration used when skin testing NMBAs.

Time Frame

1 Year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexei Gonzalez Estrada, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

12. IPD Sharing Statement

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation

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