AllergyPhase 4NCT07103720
The Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron
A Phase 4 study testing Skin Testing in people with Allergy, run by Mayo Clinic at 1 site in United States.
Trial summary
Perioperative anaphylaxis is a potentially life-threatening drug allergic reaction that can occur during anesthetic procedures. The purpose of this research is to determine the maximal nonirritating skin testing concentrations of midazolam, ketamine and ondansetron. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- 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
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2025to 10 Mar 2026
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not have a history of an adverse reactions to midazolam, ketamine or ondansetron
- Ability to understand study procedures and to comply with them for the entire length of the study.
- Contraception is not necessary, and we will include women of reproductive capability.
Who cannot join
- Unstable patients.
- History of any adverse reaction (allergy or sensitivity) to midazolam, ketamine or ondansetron.
- Pregnant and Pediatric patients
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Perioperative anaphylaxis is a potentially life-threatening drug allergic reaction that can occur during anesthetic procedures. The purpose of this research is to determine the maximal nonirritating skin testing concentrations of midazolam, ketamine and ondansetron. These drugs are FDA approved and commonly used before, during and after surgical procedures.
- 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
Participants will undergo skin prick testing and intradermal test injections at 5 increasing concentrations of midazolam, ketamine and/or ondansetron during one single study visit.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Study team is developing a new diagnostic skin testing procedure to determine non-irritant concentrations of midazolam, ketamine and ondansetron administered to patients before, during or after surgery. Receives: Diagnostic Test: Skin Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron.
Determine the maximal nonirritating concentrations of midazolam, ketamine and ondansetron
Measured: 1 Day
Secondary outcomes (1)
Skin Testing Results
Determine the frequency of false positive test results in patients who have received Midazolam, Ketamine or Ondansetron in the past.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start5 Nov 2025
- Primary completion10 Mar 2026
- Study completion10 Mar 2026
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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona Biomedical Research Commission (ABRC)
- 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
- NCT07103720
- Sponsor's protocol ID
- 25-001858
- Other IDs
- RFGA2023-008-27
- Status last verified
- Mar 2026
- First submitted
- 27 Jul 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron
- ClinicalTrials.gov ID
- NCT07103720
- Acronym / sponsor ID
- 25-001858
- Conditions
- Allergy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Arizona Biomedical Research Commission (ABRC)
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 5 Aug 2025 (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.
Perioperative anaphylaxis is a potentially life-threatening drug allergic reaction that can occur during anesthetic procedures. The purpose of this research is to determine the maximal nonirritating skin testing concentrations of midazolam, ketamine and ondansetron. These drugs are FDA approved and commonly used before, during and after surgical procedures.
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 to determine non-irritant concentrations of midazolam, ketamine and ondansetron administered to patients before, during or after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Not have a history of an adverse reactions to midazolam, ketamine or ondansetron
- Ability to understand study procedures and to comply with them for the entire length of the study.
- Contraception is not necessary, and we will include women of reproductive capability.
Key exclusion criteria (4 listed)
- Unstable patients.
- History of any adverse reaction (allergy or sensitivity) to midazolam, ketamine or ondansetron.
- Pregnant and Pediatric patients
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
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 TestingParticipants will undergo skin prick testing and intradermal test injections at 5 increasing concentrations of midazolam, ketamine and/or ondansetron during one single study visit. | Diagnostic test | Study Group |
Primary outcome
Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron.
Time frame: 1 Day
Determine the maximal nonirritating concentrations of midazolam, ketamine and ondansetron
1 secondary outcome
Skin Testing Results
Time frame: 1 Day
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 1 Apr 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Phase 4 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 3 inclusion and 4 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 1 Apr 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron. (time frame: 1 Day). 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 1 Apr 2026.