Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT03653520
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2018-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003975', 'term': 'Diazepam'}, {'id': 'D014147', 'term': 'Tramadol'}, {'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-03', 'size': 52164, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-18T16:16', 'hasProtocol': True}, {'date': '2017-04-03', 'size': 134172, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-08-18T16:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'The surgeon was not aware which medication the patient received'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 651}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-28', 'studyFirstSubmitDate': '2018-08-23', 'studyFirstSubmitQcDate': '2018-08-28', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patient who needed additional IV medication for cataract surgery', 'timeFrame': '1 day', 'description': 'Patients who require IV medications for self-reported pain or anxiety during surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesized that the combination of Valium, Tramadol and Zofran is superior to the substantially more expensive MKO melt in patient satisfaction after cataract surgery.', 'detailedDescription': "The MKO melt is being marketed as an anesthetic medication for cataract surgery that has the advantage that it eliminates the need for an IV in 85% of patients although that number was established anecdotally. This alternative, however, is very cost limiting.The investigators wanted to see if the current regimen (valium only) or a combination similar to the MKO melt (valium + tramadol + zofran) are as good if not better than the MKO melt for anesthesia and how many patients could have indeed gone with an intravenous line (didn't need any extra medications)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients scheduled to undergo cataract surgery with Drs. Mayo and Wade at Kirby Glen Surgery Center\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Patient is not suitable for the medications for reasons such as unsteady gait, cane, wheelchair, severe dementia (unable to consent), terminal illness\n* Allergy to a medication in protocol'}, 'identificationModule': {'nctId': 'NCT03653520', 'briefTitle': 'Conscious Sedation Efficacy of the MKO Melt (Midazolam, Ketamine, Ondansetron)', 'organization': {'class': 'OTHER', 'fullName': 'Avanti Anesthesia'}, 'officialTitle': 'Conscious Sedation Efficacy of the Novel Medication, MKO Melt (Midazolam, Ketamine, Ondansetron), During Cataract Surgery', 'orgStudyIdInfo': {'id': 'ANES001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'diazepam only (group 1)', 'description': 'Patients are given 5 or 10mg of diazepam for sedation before surgery for sedation', 'interventionNames': ['Drug: Diazepam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'diazepam/tramadol/ondansetron (group 2)', 'description': 'Patients are given 5 or 10mg of diazepam, 50 or 100mg of tramadol and 4 or 8mg of ondansetron orally before surgery for sedation', 'interventionNames': ['Drug: Diazepam', 'Drug: Tramadol', 'Drug: Ondansetron']}, {'type': 'EXPERIMENTAL', 'label': 'MKO only (group 3)', 'description': 'Patients are given 1 or 2 MKO melts (each contain 3mg midazolam, 25mg ketamine, 2mg ondansetron) sublingually before surgery for sedation', 'interventionNames': ['Drug: MKO melt']}], 'interventions': [{'name': 'Diazepam', 'type': 'DRUG', 'description': '5 or 10mg', 'armGroupLabels': ['diazepam only (group 1)', 'diazepam/tramadol/ondansetron (group 2)']}, {'name': 'Tramadol', 'type': 'DRUG', 'description': '50mg or 100mg', 'armGroupLabels': ['diazepam/tramadol/ondansetron (group 2)']}, {'name': 'Ondansetron', 'type': 'DRUG', 'description': '1 or two tabs', 'armGroupLabels': ['diazepam/tramadol/ondansetron (group 2)']}, {'name': 'MKO melt', 'type': 'DRUG', 'description': '1 or 2 MKO melts', 'armGroupLabels': ['MKO only (group 3)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann Kirby Glen Surgery Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Maggie Jeffries, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Avanti Anesthesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'De-identified individual participant data for all primary and secondary outcome measures will be available to those who contact primary investigator. We may decide to fully publish data but are undecided.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avanti Anesthesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maggie Jeffries', 'investigatorAffiliation': 'Avanti Anesthesia'}}}}