Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-01-08 @ 3:23 AM
Study NCT ID:
NCT07166666
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Atomizerd Midazolam & Fentanyl and Dexmedomidine for Procedural Sedation in Adult and Pediatric Patient (2 to 60 Years Old)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009330', 'term': 'Nebulizers and Vaporizers'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}, {'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': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-09-08', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'depth of sedtion', 'timeFrame': '1 year', 'description': "using MOAA/S score, Modified Observer's Assessment of Alertness/Sedation Scale , as 0 high score for deep sedation, 5 not in deep sedation"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sedation', 'Analgesia Assessment']}, 'descriptionModule': {'briefSummary': 'To evaluate the depth of sedation, as well as onset, and recovery times, satisfaction of sedation , adverse events associated with Atomized Midazolam \\& Fentanyl and Dexmedetomidine during procedural sedation in a diverse population spanning from 2 to 60 years old at these three prominent Omani healthcare facilities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '2 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* inclusion criteria:\n\n 1. Patients aged 2 to 60 years.\n 2. Patients undergoing EM procedures requiring sedation.\n\nExclusion criteria:\n\n1. Patients with contraindications to any of the sedation agents being studied.\n2. Patients with a history of adverse reactions or allergies to the study medications.\n3. Drug interactions: Patients taking certain medications that may interact adversely with the study medications.\n4. Drug Abuser\n5. Pregnancy and breastfeeding\n6. Patients with significant cardiovascular or respiratory compromise.\n7. Patients with nasal disorder (nasal trauma, epistaxis)\n8. Patients unable to provide informed consent or those with cognitive impairment.\n9. Patients who are \\< 2 year of age or \\> 60 year of age.\n10. Patient underwent procedure sedation for imaging'}, 'identificationModule': {'nctId': 'NCT07166666', 'briefTitle': 'Study Comparing Atomizerd Midazolam & Fentanyl and Dexmedomidine for Procedural Sedation in Adult and Pediatric Patient (2 to 60 Years Old)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Oman Medical Speciality Board'}, 'officialTitle': 'Study Comparing Atomizerd Midazolam & Fentanyl and Dexmedomidine for Procedural Sedation in Adult and Pediatric Patient (2 to 60 Years Old)', 'orgStudyIdInfo': {'id': 'MoH/CSR/24/28497'}, 'secondaryIdInfos': [{'id': 'MOH/ oman', 'type': 'OTHER', 'domain': 'MOH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'midazolame $ fentanyl', 'description': 'use as compare between two group', 'interventionNames': ['Device: atomizer', 'Drug: rescue medication', 'Drug: Midazolam', 'Drug: fentanyl']}, {'type': 'OTHER', 'label': 'dexetomidate', 'description': 'use as compare to other group', 'interventionNames': ['Device: atomizer', 'Drug: rescue medication', 'Drug: Dexmedetomidine', 'Drug: Placabo']}], 'interventions': [{'name': 'atomizer', 'type': 'DEVICE', 'description': 'use atomizer to provide the medication in procedure sedation', 'armGroupLabels': ['dexetomidate', 'midazolame $ fentanyl']}, {'name': 'rescue medication', 'type': 'DRUG', 'description': 'will be used as rescue if the atomizer medication not fully sedated', 'armGroupLabels': ['dexetomidate', 'midazolame $ fentanyl']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Intranasal administration for procedural sedation.', 'armGroupLabels': ['midazolame $ fentanyl']}, {'name': 'fentanyl', 'type': 'DRUG', 'description': 'Intranasal administration for procedural sedation.', 'armGroupLabels': ['midazolame $ fentanyl']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Intranasal administration for procedural sedation.', 'armGroupLabels': ['dexetomidate']}, {'name': 'Placabo', 'type': 'DRUG', 'description': 'use atomizer to provide the placebo in procedure sedation', 'armGroupLabels': ['dexetomidate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Muscat', 'country': 'Oman', 'facility': 'dr.Suad al baluish', 'geoPoint': {'lat': 23.58413, 'lon': 58.40778}}], 'centralContacts': [{'name': 'Ghaliy khamis al noofli, MD', 'role': 'CONTACT', 'email': 'r23029@resident.omsb.org', 'phone': '+96895751564'}, {'name': 'ahoud abdullah al saidi, MD', 'role': 'CONTACT', 'email': 'r23031@resident.omsb.org', 'phone': '+96892903021'}], 'overallOfficials': [{'name': 'saud al bulashi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MOH/ oman'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oman Medical Speciality Board', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ghaliya Al Noofli', 'investigatorAffiliation': 'Oman Medical Speciality Board'}}}}