The Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron

March 27, 2026 updated by: Alexei Gonzalez-Estrada, MD, Mayo Clinic
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 4

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
    • Arizona
      • Scottsdale, Arizona, United States, 85268
        • Mayo Clinic Arizona

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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 to determine non-irritant concentrations of midazolam, ketamine and ondansetron administered to patients before, during or after surgery.
Diagnostic test: Skin Testing
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron.
Time Frame: 1 Day
Determine the maximal nonirritating concentrations of midazolam, ketamine and ondansetron
1 Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Testing Results
Time Frame: 1 Day
Determine the frequency of false positive test results in patients who have received Midazolam, Ketamine or Ondansetron in the past.
1 Day

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Collaborators

Arizona Biomedical Research Commission (ABRC)

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)

November 5, 2025

Primary Completion (Actual)

March 10, 2026

Study Completion (Actual)

March 10, 2026

Study Registration Dates

First Submitted

July 27, 2025

First Submitted That Met QC Criteria

August 1, 2025

First Posted (Actual)

August 5, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-001858
  • RFGA2023-008-27 (Other Grant/Funding Number: Arizona Biomedical Research Commission (ABRC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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