The Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron

NCT07103720 | Completed Phase 4 FDA Drug

• 2 other identifiers: 25-001858RFGA2023-008-27
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. These drugs are FDA approved and commonly used before, during and after surgical procedures.

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

• Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron.

  Determine the maximal nonirritating concentrations of midazolam, ketamine and ondansetron

  1 Day

Secondary Outcomes (1)

• Skin Testing Results

  1 Day

Study Arms (1)

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.

Diagnostic Test: Skin Testing

Interventions

Skin Testing DIAGNOSTIC_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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Arizona Biomedical Research Commission (ABRC): collaborator

Study Sites (1)

Mayo Clinic Arizona

Scottsdale, Arizona, 85268, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hypersensitivity

Interventions

Skin Tests

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Alexei Gonzalez Estrada, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alexei Gonzalez-Estrada, M.D.

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 5, 2025
• Study Start: November 5, 2025
• Primary Completion: March 10, 2026
• Study Completion: March 10, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)