Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-30 @ 5:02 PM
Study NCT ID:
NCT05640934
Status:
COMPLETED
Last Update Posted:
2023-07-17
First Post:
2022-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Melatonin for Post Operative Delirium Prevention in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-14', 'studyFirstSubmitDate': '2022-11-29', 'studyFirstSubmitQcDate': '2022-11-29', 'lastUpdatePostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of delirium occurrence', 'timeFrame': 'Perioperative.', 'description': 'Nursing delirium - screening score. It scores five items,Each item is rated from 0 to 2 where 0, absent; 1, mild; 2, severe. A score ≥ 2 is considered to have delirium.'}], 'secondaryOutcomes': [{'measure': 'Degree of Sedation', 'timeFrame': 'Perioperative.', 'description': 'Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation'}, {'measure': 'Intensity of pain', 'timeFrame': 'Perioperative', 'description': 'Pain Assessment in Advanced Dementia Scale from 0 to 10 . score 1 to 3=mild pain; 4 to 6=moderate pain; 7-to 10=severe pain.'}, {'measure': 'Mean arterial blood pressure', 'timeFrame': 'Perioperative', 'description': 'mmHg'}, {'measure': 'Heart rate', 'timeFrame': 'Perioperative', 'description': 'beats/minute'}, {'measure': 'Hypotension', 'timeFrame': 'Perioperative', 'description': 'Number of patients with hypotension'}, {'measure': 'Hypoxia', 'timeFrame': 'Perioperative', 'description': 'Number of patients with hypoxia'}, {'measure': 'Blood transfusion needs', 'timeFrame': 'Perioperative', 'description': 'Number of patients needed blood transfusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delirium in Old Age']}, 'descriptionModule': {'briefSummary': 'The present study will evaluate the role of melatonin prophylaxis in delirium prevention in elderly patients undergoing colorectal procedures.', 'detailedDescription': 'This study is a prospective randomised double-blind placebo-controlled trial. Patients who meet the criteria for inclusion/exclusion will be evaluated. Melatonin tablets will be administered as a premedication to patients in the melatonin group. Patients in the control group will be given placebo tablets as a premedication. Fentanyl 1ug/kg and propofol 1-2 mg/kg will be used to induce anaesthesia. Atracurium 0.5 mg/kg will be used for the facilitation of endotracheal intubation. Isoflurane will be used to maintain anaesthesia and the depth of anaesthesia will be adjusted by a Bispectral index monitor. Postoperatively, the patients will be monitored for the development of delirium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anaesthesiologists (ASA) I to III physical status\n* Elective colorectal procedures\n\nExclusion Criteria:\n\n* Allergy to the research drugs,\n* Patients who have vision or hearing impairment\n* History of cerebral disorders\n* Uncorrected acid-base, fluid, and electrolyte abnormalities\n* History of central nervous system function affecting drugs.\n* Chronic sedative-hypnotic administration at least one month prior to surgery\n* Alcohol abuse\n* Patients with recorded preoperative nursing delirium screening score ≥ 2.'}, 'identificationModule': {'nctId': 'NCT05640934', 'briefTitle': 'Melatonin for Post Operative Delirium Prevention in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'The Impact of Melatonin on the Postoperative Delirium in Geriatric Patients After Colorectal Surgeries. A Randomised Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '11/2022 ANEST10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Melatonin group', 'description': 'The patients will be given 5 mg melatonin the night before surgery, 12 hours before the scheduled time of surgery, followed by another 5 mg melatonin two hours before surgery.', 'interventionNames': ['Drug: Melatonin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'The patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Melatonin', 'type': 'DRUG', 'description': 'The patients will be given 5 mg melatonin the night before surgery, 12 hours before the scheduled time of surgery, followed by another 5 mg melatonin two hours before surgery.', 'armGroupLabels': ['Melatonin group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32511', 'city': 'Cairo', 'state': 'Shebin El-kom', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Abd-Elazeem A Elbakry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Menoufia University'}, {'name': 'Hazem E Elsersy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Menoufia University'}, {'name': 'Islam M El-Desoky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Menoufia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Abd-Elazeem Abd-Elhameed Elbakry', 'investigatorAffiliation': 'Menoufia University'}}}}