Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT07066605
Status:
RECRUITING
Last Update Posted:
2025-07-15
First Post:
2025-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Dexmedetomidine on Agitation During Weaning From Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-04', 'studyFirstSubmitDate': '2025-07-04', 'studyFirstSubmitQcDate': '2025-07-04', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Dexmedetomidine on Agitation During Weaning from Mechanical Ventilation', 'timeFrame': 'every half an hour for two hours', 'description': 'Richmond Agitation-Sedation Scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dexmedetomidine']}, 'referencesModule': {'references': [{'pmid': '19188334', 'type': 'BACKGROUND', 'citation': 'Riker RR, Shehabi Y, Bokesch PM, Ceraso D, Wisemandle W, Koura F, Whitten P, Margolis BD, Byrne DW, Ely EW, Rocha MG; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009 Feb 4;301(5):489-99. doi: 10.1001/jama.2009.56. Epub 2009 Feb 2.'}, {'pmid': '30113379', 'type': 'BACKGROUND', 'citation': 'Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.'}, {'pmid': '17695343', 'type': 'BACKGROUND', 'citation': 'Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of dexmedetomidine on the level of agitation during the weaning process from mechanical ventilation in critically ill patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult ICU patients (≥18 years).\n* On mechanical ventilation ≥24 hours.\n* Clinically ready for weaning.\n* Agitation score RASS ≥ +1 during spontaneous breathing trial.\n* Intubation for at least 4 days: 2 weeks.\n\nExclusion Criteria:\n\n* Known hypersensitivity to dexmedetomidine.\n* Hemodynamic instability (HR \\< 50 bpm or MAP \\< 60 mmHg).\n* Neurological impairment affecting level of consciousness.\n* Pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT07066605', 'briefTitle': 'The Effect of Dexmedetomidine on Agitation During Weaning From Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'The Effect of Dexmedetomidine on Agitation During Weaning From Mechanical Ventilation in Critically Ill Patients"', 'orgStudyIdInfo': {'id': 'Soh-Med-25-6---17MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (Dexmedetomidine Group)', 'description': 'patients will receive dexmedetomidine infusion starting at 0.2 mcg/kg/hr.', 'interventionNames': ['Drug: Group A (Dexmedetomidine Group)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B (Control Group)', 'description': 'patients will receive standard ICU sedation protocol without dexmedetomidine (e.g., fentanyl)', 'interventionNames': ['Drug: Group B (Control Group)']}], 'interventions': [{'name': 'Group A (Dexmedetomidine Group)', 'type': 'DRUG', 'description': 'patients will receive dexmedetomidine infusion starting at 0.2 mcg/kg/hr.', 'armGroupLabels': ['Group A (Dexmedetomidine Group)']}, {'name': 'Group B (Control Group)', 'type': 'DRUG', 'description': 'patients will receive standard ICU sedation protocol without dexmedetomidine (e.g., fentanyl)', 'armGroupLabels': ['Group B (Control Group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, Professor', 'role': 'CONTACT', 'phone': '01090801900'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Dalia A Hussein, Resident', 'role': 'CONTACT', 'email': 'najiza330@gmail.com', 'phone': '01017666214'}, {'name': 'Al-haddad A Mousa, Professor', 'role': 'CONTACT', 'phone': '01019816967'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident, Department of Anesthesia, Intensive Care and Pain management, Faculty of Medicine, Sohag University', 'investigatorFullName': 'Dalia Ayman Hussien', 'investigatorAffiliation': 'Sohag University'}}}}