Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-30 @ 8:17 PM
Study NCT ID:
NCT06808295
Status:
RECRUITING
Last Update Posted:
2025-02-05
First Post:
2024-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine an Effective Drug in Reducing Anesthetic Requirements in External Dacrocystorhinostomy (DCR) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 Groups, Dexmedetomidine group and control group are assigned'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2024-12-14', 'studyFirstSubmitQcDate': '2025-01-31', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maintained hemodynamic values while reducing the anesthetic requirements', 'timeFrame': 'from 20 minutes after administering the drug till 2 hours after full recovery', 'description': 'Measuring the heart rate and the blod pressure every 5 minutes intraoperative and for half an hour postoperative to assess hemodynamic stability'}], 'secondaryOutcomes': [{'measure': 'Delerium', 'timeFrame': 'from 20 minutes after administering the drug till 2 hours after full recovery', 'description': 'Reducing postoperative delirium in elderly patients'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients Undergoing External Dacrocystorhinostomy Operations', 'Assess Decreased Anesthetic Requirements Intraoperative']}, 'descriptionModule': {'briefSummary': 'Assessing the intra and postoperative hemodynamic stability in patients undergoing external dacrocystorhinostomy under general anesthesia using Dexmedetomidine as a preoperative sedation compared to traditional technique with intraoperative analgesia and assessing decreased anesthetic requirements intra and postoperative', 'detailedDescription': 'Dexmedetomidine is a highly selective alpha 2 adrenoceptor agonist, having characteristics of natural sleep like sedation, can reduce pain intensity and opioid consumption without influencing the time of recovery from general anesthesia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients of both sexes 16 years to 75 years of age ASA (American society of Anesthesiologists) I-III\n\nExclusion Criteria:\n\n* Pediatric age group\n* ASA more than III'}, 'identificationModule': {'nctId': 'NCT06808295', 'acronym': 'DCR', 'briefTitle': 'Dexmedetomidine an Effective Drug in Reducing Anesthetic Requirements in External Dacrocystorhinostomy (DCR) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Research Institute of Ophthalmology, Egypt'}, 'officialTitle': 'Dexmedetomidine As an Effective Drug in Reducing Anesthetic Requirements in Patients Undergoing External Dacrocystorhinostomy, a Randomized Controlled Study', 'orgStudyIdInfo': {'id': '24-11-17-6-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine', 'description': 'Dexmedetomidine 0.25 microgram per kilogram is used in Dacrocystorhinostomy patients 20 minutes before induction of general anesthesia', 'interventionNames': ['Drug: Dexmedetomidine Hydrochloride']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Fentanyl as an analgesic is used with general anesthesia in Dacrocystorhinostomy patients'}], 'interventions': [{'name': 'Dexmedetomidine Hydrochloride', 'type': 'DRUG', 'description': 'drug will be given before induction and anesthetic doses and hemodynamics will be assessed pre- intra and postoperative', 'armGroupLabels': ['Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Research Institute of Ophthalmolgy', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Dina Moustafa Mohamed Ali, MD', 'role': 'CONTACT', 'email': 'dina.moustafa.ali@gmail.com', 'phone': '01113981021'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Research Institute of Ophthalmology, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Dina Moustafa Mohamed', 'investigatorAffiliation': 'Research Institute of Ophthalmology, Egypt'}}}}