Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT05224167
Status:
UNKNOWN
Last Update Posted:
2022-02-04
First Post:
2022-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}, {'id': 'D000286', 'term': 'Administration, Sublingual'}, {'id': 'D006919', 'term': 'Hydroxyzine'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D000284', 'term': 'Administration, Oral'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-25', 'studyFirstSubmitDate': '2022-01-25', 'studyFirstSubmitQcDate': '2022-01-25', 'lastUpdatePostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'preoperative anxiety', 'timeFrame': '1 hour before surgery', 'description': 'preoperative anxiety scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Melatonin', 'Hydroxizin', 'Hip fracture'], 'conditions': ['Preoperative Anxiety']}, 'descriptionModule': {'briefSummary': 'prospective randomized trial including adukt patients scheduled for hip fracture surgery, Randomization into 2 groups: Group A: Hydroxizin peroperatively Group B: Melatonin pre operatively', 'detailedDescription': 'prospective randomized trial including adukt patients scheduled for hip fracture surgery, Randomization into 2 groups: Group A: Hydroxizin peroperatively Group B: Melatonin pre operatively\n\nNon inclusion criteria: patients with severe cognitive impairement Primary outcome pre operative anxiety assessed with Amsterdam preoperative anxiety and information scale'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients scheduled for hip fracture surgery\n\nExclusion Criteria:\n\n* Patients with contraindications for hydroxizine or Melatonin Patients with severe cognitive impairement'}, 'identificationModule': {'nctId': 'NCT05224167', 'briefTitle': 'Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Mongi Slim Hospital'}, 'officialTitle': 'Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture', 'orgStudyIdInfo': {'id': 'Melatonin versus Hydroxizin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'patients of this group will receive 5 mg of Melatonin 12 hours and 5 mg 2 hours prior to surgery', 'interventionNames': ['Drug: Melatonin 5 MG Sublingual Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'patients of this group will receive 1 mg/kg of Hydroxizin 12 hours and 1 mg/ kg 2 hours prior to surgery', 'interventionNames': ['Drug: Hydroxyzine']}], 'interventions': [{'name': 'Melatonin 5 MG Sublingual Tablet', 'type': 'DRUG', 'description': 'Melatonin 5 mg 12 hours and 2 hours prior to surgery', 'armGroupLabels': ['Group A']}, {'name': 'Hydroxyzine', 'type': 'DRUG', 'description': 'Hydroxyzine 1mg/kg 12 hours and 2 hours prior to surgery', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mhamed Sami Mebazaa, Prof', 'role': 'CONTACT', 'email': 'msmebazaa@gmail.com', 'phone': '0021622252589'}, {'name': 'Asma Ben Souissi, Assoc Prof', 'role': 'CONTACT', 'email': 'bsouissiasma@gmail.com', 'phone': '0021698336883'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mongi Slim Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor head of anesthesia and intensive care department', 'investigatorFullName': 'Mhamed Sami Mebazaa', 'investigatorAffiliation': 'Mongi Slim Hospital'}}}}