Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
Study NCT ID:
NCT04096768
Status:
UNKNOWN
Last Update Posted:
2020-02-20
First Post:
2019-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 394}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2019-09-15', 'studyFirstSubmitQcDate': '2019-09-17', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring blood pressure to assess hypotension when using a combination of the two drugs for sedation versus Dexmedetomidine and placebo only', 'timeFrame': 'Within 24 hours of drugs administration', 'description': 'Measuring blood pressure to assess hypotension when using a combination of the two drugs for sedation versus Dexmedetomidine and placebo only'}], 'secondaryOutcomes': [{'measure': 'Measuring the doses of dexmedetomidine and ketamine when combined and the doses of dexmedetomidine when used alone to achieve desired level of sedation', 'timeFrame': 'Within 24 hours of drugs administration', 'description': 'Measuring the doses of dexmedetomidine and ketamine when combined and the dose of dexmedetomidine when used alone to achieve desired level of sedation'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ICU Patients', 'Sedation']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the use of dexmedetomidine + ketamine with dexmedetomidine + placebo for sedation in ICU patients in terms of safety and efficacy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-80 years old\n* Admitted to Intensive care unit at LAUMCRH\n* Need for sedation for at least 24 hours\n* Informed Consent Form signed by patient or surrogate\n\nExclusion Criteria:\n\n* Pregnant patients\n* At risk of increased intracranial pressure\n* Aortic dissection\n* Acute coronary syndrome\n* Hypertension (SBP \\> 180 mmHg)\n* Chronic alcoholism\n* Acute alcohol intoxication\n* Alcohol withdrawal\n* Refractory status epilepticus\n* History of psychiatric disorder\n* Known allergy or contraindication to use of dexmedetomidine or ketamine\n* Baseline hypotension (MAP\\<65 mmHg)\n* Baseline bradycardia (HR\\<48 bpm)\n* Patients receiving neuromuscular blocking agents\n* Patients requiring deep sedation as determined by the ICU attending'}, 'identificationModule': {'nctId': 'NCT04096768', 'briefTitle': 'The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation', 'organization': {'class': 'OTHER', 'fullName': 'Lebanese American University Medical Center'}, 'officialTitle': 'Combining Dexmedetomidine and Ketamine in Intensive Care Sedation: Efficacy and Safety', 'orgStudyIdInfo': {'id': 'FA2.2016.R2.21/Jun/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine + Ketamine', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: Ketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dexmedetomidine + Placebo', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients', 'armGroupLabels': ['Dexmedetomidine + Ketamine', 'Dexmedetomidine + Placebo']}, {'name': 'Ketamine', 'type': 'DRUG', 'description': 'Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients', 'armGroupLabels': ['Dexmedetomidine + Ketamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Beirut', 'status': 'RECRUITING', 'country': 'Lebanon', 'contacts': [{'name': 'Fayez Abillama, MD', 'role': 'CONTACT', 'email': 'fayez.abillama@gmail.com', 'phone': '01200800', 'phoneExt': '6420'}, {'name': 'Yara Kuyumdjian, Pharm.D', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Lebanese American University Medical Center- Rizk Hospital', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'centralContacts': [{'name': 'Fayez Abillama, MD', 'role': 'CONTACT', 'email': 'fayez.abillama@gmail.com', 'phone': '01200800', 'phoneExt': '6420'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lebanese American University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Intensive Care Medicine Physician', 'investigatorFullName': 'Fayez Abillama, MD', 'investigatorAffiliation': 'Lebanese American University Medical Center'}}}}