Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT07103720
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012882', 'term': 'Skin Tests'}], 'ancestors': [{'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-07-27', 'studyFirstSubmitQcDate': '2025-08-01', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron.', 'timeFrame': '1 Day', 'description': 'Determine the maximal nonirritating concentrations of midazolam, ketamine and ondansetron'}], 'secondaryOutcomes': [{'measure': 'Skin Testing Results', 'timeFrame': '1 Day', 'description': 'Determine the frequency of false positive test results in patients who have received Midazolam, Ketamine or Ondansetron in the past.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Not have a history of an adverse reactions to midazolam, ketamine or ondansetron\n* Ability to understand study procedures and to comply with them for the entire length of the study.\n* Contraception is not necessary, and we will include women of reproductive capability.\n\nExclusion Criteria:\n\n* Unstable patients.\n* History of any adverse reaction (allergy or sensitivity) to midazolam, ketamine or ondansetron.\n* Pregnant and Pediatric patients\n* Inability or unwillingness of individual or legal guardian/representative to give written informed consent.'}, 'identificationModule': {'nctId': 'NCT07103720', 'briefTitle': 'The Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'The Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron', 'orgStudyIdInfo': {'id': '25-001858'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study 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.', 'interventionNames': ['Diagnostic Test: Skin Testing']}], 'interventions': [{'name': 'Skin Testing', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85268', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexei Gonzalez Estrada, MD', 'role': 'CONTACT', 'email': 'gonzalez.alexei@mayo.edu', 'phone': '480-301-4284'}, {'name': 'Alexei Gonzalez Estrada, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Alexei Gonzalez Estrada, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Arizona Biomedical Research Commission (ABRC)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Alexei Gonzalez-Estrada, M.D.', 'investigatorFullName': 'Alexei Gonzalez-Estrada, MD', 'investigatorAffiliation': 'Mayo Clinic'}}}}