Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-30 @ 8:39 AM
Study NCT ID:
NCT06076668
Status:
UNKNOWN
Last Update Posted:
2023-10-17
First Post:
2023-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D008550', 'term': 'Melatonin'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-16', 'studyFirstSubmitDate': '2023-09-16', 'studyFirstSubmitQcDate': '2023-10-07', 'lastUpdatePostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of delirium', 'timeFrame': '14 days from admission to intensive care unit', 'description': 'The incidence of delirium within 14 days from admission to the intensive care unit (ICU) or until ICU discharge before this time. Every 12 hours throughout the study.'}], 'secondaryOutcomes': [{'measure': 'The onset of delirium. • Duration of delirium. • Frequency of delirium. • Length of ICU stay. • Total dose of Haloperidol per day.', 'timeFrame': '14 days from admission to intensive care unit', 'description': 'Delirium was assessed using Confusion Assessment Method for intensive care unit (CAM- ICU) score at admission to ICU and every 12hr throughout the study.\n\nThe final CAM-ICU score ranges from 0-7 with 7 being most severe. CAM-ICU-7 scores were further categorized as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium.'}, {'measure': 'Duration of delirium', 'timeFrame': '14 days from admission to intensive care unit', 'description': 'Delirium was assessed using Confusion Assessment Method for intensive care unit(CAM- ICU) score at admission to ICU and every 12hr throughout the study.\n\nThe final CAM-ICU score ranges from 0-7 with 7 being most severe. CAM-ICU-7 scores were further categorized as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium.'}, {'measure': 'Frequency of delirium', 'timeFrame': '14 days from admission to intensive care unit', 'description': 'Delirium was assessed using Confusion Assessment Method for intensive care unit(CAM- ICU)score at admission to ICU and every 12hr throughout the study.\n\nThe final CAM-ICU score ranges from 0-7 with 7 being most severe. CAM-ICU-7 scores were further categorized as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium.'}, {'measure': 'Total dose of Haloperidol per day', 'timeFrame': '14 days from admission to intensive care unit', 'description': 'Total dose of Haloperidol per day 14 days from admission to intensive care unit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dexmedetomidine', 'Melatonin', 'Delirium']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effect of dexmedetomidine infusion and oral melatonin on preventing delirium in intensive care unit (ICU) patients.', 'detailedDescription': 'Delirium is experienced in 20% to 40% of the critically ill and up to 80% of mechanically ventilated (MV) medical or surgical patients . It is a confessional state that has been described as a transient global disorder of cognition, awareness, and attention and as such is not only challenging for the treating medical team, but also has a considerable impact on affected patients. It is associated with prolonged hospital length of stay and time on MV, deterioration in cognition, and increased morbidity and mortality causing additional health-care expenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 21 years or older.\n* Either gender.\n* Healthy gastrointestinal function (patients tolerated oral medications by gavage or mouth).\n* Richmond Agitation Sedation Scale (RASS) \\>-1.\n* No basic delirium or mood changes before admission to intensive care unit(ICU).\n\nExclusion Criteria:\n\n* Patient refusal.\n* History of irreversible brain disease consistent with severe dementia.\n* Patient admitted with a primary neurologic condition or injury (e.g., intracranial hemorrhage).\n* Heart rate (HR) less than 50 beats/ min or second- third degree heart block in the absence of a pacemaker.\n* Acute alcohol withdrawal requiring benzodiazepine administration.\n* History of hepatic encephalopathy or end-stage liver disease (Child-Pugh class B or C).\n* The expected duration of intensive care unit (ICU) stay less than 5 days.\n* Inability to obtain informed consent.\n* Pregnancy.\n* Allergy to dexmedetomidine or melatonin.'}, 'identificationModule': {'nctId': 'NCT06076668', 'briefTitle': 'Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Delirium', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Dexmedetomidine Infusion Versus Oral Melatonin for Prevention of Intensive Care Unit (ICU) Delirium; A Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'Dexmedetomidine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group D (n=30)', 'description': 'patients will receive intravenous dexmedetomidine infusion of 0.2 mcg/kg/h starting at 9 p.m. The infusion will be halved at 6:00 A.M. and discontinued at 6:15 A.M.', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'EXPERIMENTAL', 'label': 'Group M (n=30)', 'description': 'patients will receive oral melatonin tablet 3 mg at 9:00 p.m.', 'interventionNames': ['Drug: Melatonin 3 MG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'patients will receive saline infusion at the same rate of dexmedetomidine infusion and placebo capsule similar to that of melatonin.', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['DEX group'], 'description': 'Patients will receive an intravenous dexmedetomidine infusion of 0.2 mcg/kg/h starting at 9 p.m. The infusion will be halved at 6:00 A.M. and discontinued at 6:15 A.M.', 'armGroupLabels': ['Group D (n=30)']}, {'name': 'Melatonin 3 MG', 'type': 'DRUG', 'otherNames': ['N-acetyl-5-methoxytryptamine'], 'description': 'Patients will receive oral melatonin tablet 3 mg 9:00 p.m.', 'armGroupLabels': ['Group M (n=30)']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['Control group'], 'description': 'Patients will receive saline infusion at the same rate of dexmedetomidine infusion and placebo capsule similar to that of melatonin.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Eslam M Salem, Msc', 'role': 'CONTACT', 'email': 'salemeslam913@gmail.com', 'phone': '00201004415074'}, {'name': 'Ayman A Youssef, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ghada F El-baradey, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shaimaa F Abdelkader, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alaa M Abo Hagar, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Eslam Eslam, MD', 'role': 'CONTACT', 'email': 'salemeslam913@gmail.com', 'phone': '01004415074'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'eslam salem', 'investigatorAffiliation': 'Tanta University'}}}}