Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT01126294
Status:
UNKNOWN
Last Update Posted:
2010-05-19
First Post:
2010-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Melatonin in Lumbar Laminectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-18', 'studyFirstSubmitDate': '2010-05-17', 'studyFirstSubmitQcDate': '2010-05-18', 'lastUpdatePostDateStruct': {'date': '2010-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': '24 hours', 'description': 'Pain will be assessed over a 24 hour period following surgery using a visual analogue scale'}, {'measure': 'Anxiety', 'timeFrame': '24 hours', 'description': 'Anxiety will be assessed over a 24 hour following surgery using visual analogue scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lumbar laminectomy, melatonin, perioperative, pain, anxiety, analgesia, VAS score'], 'conditions': ['Pain and Anxiety in Patients Undergoing Surgery for Lumbar Laminectomy.']}, 'referencesModule': {'references': [{'pmid': '33319916', 'type': 'DERIVED', 'citation': 'Madsen BK, Zetner D, Moller AM, Rosenberg J. Melatonin for preoperative and postoperative anxiety in adults. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD009861. doi: 10.1002/14651858.CD009861.pub3.'}]}, 'descriptionModule': {'briefSummary': 'Patients undergoing lumbar laminectomy surgery will receive either 5 or 10 mg melatonin or placebo once the evening before surgery and again 90 minutes before surgery. Pain and anxiety will be assessed over the 24 hour period following surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 to 65 years old\n* ASA status 1-3\n* having lumbar laminectomy 2 to 3 levels with or without fusion\n\nExclusion Criteria:\n\n* receiving emergent procedure\n* surgery for neoplastic spine lesion\n* allergy to melatonin or its non-medicinal ingredients\n* allergy or contraindication\n* BMI over 35 or or less than 20 kg/m2\n* pregnancy or breastfeeding\n* failure to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01126294', 'briefTitle': 'Perioperative Melatonin in Lumbar Laminectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Perioperative Analgesic and Anxiolytic Effect of Melatonin in Patients Undergoing Lumbar Laminectomy', 'orgStudyIdInfo': {'id': '09-0172-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Melatonin 5 mg', 'description': 'Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.', 'interventionNames': ['Dietary Supplement: 5 mg melatonin']}, {'type': 'EXPERIMENTAL', 'label': 'Melatonin 10 mg', 'description': 'Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.', 'interventionNames': ['Dietary Supplement: 10 mg melatonin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': '5 mg melatonin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.', 'armGroupLabels': ['Melatonin 5 mg']}, {'name': '10 mg melatonin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.', 'armGroupLabels': ['Melatonin 10 mg']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Uma Victor, MBBS', 'role': 'CONTACT', 'email': 'uma.victor@uhn.on.ca', 'phone': '416 603-5800', 'phoneExt': '6137'}, {'name': 'Philip Peng, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Philip Peng, MD', 'role': 'CONTACT', 'email': 'philip.peng@uhn.on.ca', 'phone': '416 603-5118'}], 'overallOfficials': [{'name': 'Philip Peng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Philip Peng', 'oldOrganization': 'University Health Network'}}}}