The Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron

Mayo Clinic

Status and phase: Enrolling; Phase 4

Conditions: Allergy

Treatments: Diagnostic Test: Skin Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT07103720

25-001858

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Study Group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Skin Testing