AllergyNCT04046731
Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation
A study testing Skin Testing in people with Allergy, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergy
- What is being tested?
- Skin Testing
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults > or = to 18 y/o undergoing surgery
Who cannot join
- Minors under the age of 18 y/o, Adults unable to consent, or those Adults with previous allergic reaction history during previous surgeries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Allergy
- Being tested
- Skin Testing
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin TestingDiagnostic test
Percutaneous skin prick followed by Intradermal Injections of NMBAs at increasing concentrations compared with an established positive and negative control.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | 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. Receives: Diagnostic Test: Skin Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Irritant Concentrations to common NMBAs
Determine the NIC to common NMBAs
Measured: 1 Year
Secondary outcomes (2)
Negative Predictive Value of Intradermal Skin Testing to commonly used NMBAs
Determine Negative Predictive Value of Intradermal Skin Testing to commonly used NMBAs
Measured: 1 Year
Max Concentration used when skin testing to NMBAs
Close gap on the variability of the maximal concentration used when skin testing NMBAs.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start20 Sep 2019
- Primary completion30 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexei Gonzalez-Estrada, MD, Mayo Clinic
- Investigators
- Alexei Gonzalez Estrada, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046731
- Sponsor's protocol ID
- 18-007462
- Status last verified
- Feb 2022
- First submitted
- 5 Aug 2019
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Negative Predictive Value and Non-irritant Skin Testing Concentrations of Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation
- ClinicalTrials.gov ID
- NCT04046731
- Acronym / sponsor ID
- 18-007462
- Conditions
- Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Diagnostic Test: Skin TestingStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults > or = to 18 y/o undergoing surgery
Key exclusion criteria (1 listed)
- Minors under the age of 18 y/o, Adults unable to consent, or those Adults with previous allergic reaction history during previous surgeries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin TestingPercutaneous skin prick followed by Intradermal Injections of NMBAs at increasing concentrations compared with an established positive and negative control. | Diagnostic test | Study Group |
Primary outcome
Non-Irritant Concentrations to common NMBAs
Time frame: 1 Year
Determine the NIC to common NMBAs
2 secondary outcomes
Negative Predictive Value of Intradermal Skin Testing to commonly used NMBAs
Time frame: 1 Year
Max Concentration used when skin testing to NMBAs
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexei Gonzalez Estrada, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin Testing in people with Allergy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-Irritant Concentrations to common NMBAs (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022; AzTrials last refreshed its copy on 29 Oct 2026.