Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-25 @ 4:08 PM
Study NCT ID:
NCT00311259
Status:
UNKNOWN
Last Update Posted:
2006-04-05
First Post:
2006-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Melatonin Treatment and Inflammation, Oxidative Stress and Autonomic Function in Connection With Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-02', 'completionDateStruct': {'date': '2006-11'}, 'lastUpdateSubmitDate': '2006-04-03', 'studyFirstSubmitDate': '2006-04-03', 'studyFirstSubmitQcDate': '2006-04-03', 'lastUpdatePostDateStruct': {'date': '2006-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-05', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Oxidative Stress', 'Inflammatory Stress', 'Myocardial Ischaemia']}, 'referencesModule': {'references': [{'pmid': '20887414', 'type': 'DERIVED', 'citation': 'Kucukakin B, Klein M, Lykkesfeldt J, Reiter RJ, Rosenberg J, Gogenur I. No effect of melatonin on oxidative stress after laparoscopic cholecystectomy: a randomized placebo-controlled trial. Acta Anaesthesiol Scand. 2010 Oct;54(9):1121-7. doi: 10.1111/j.1399-6576.2010.02294.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether treatment with melatonin can reduce cell damage and inflammation in connection with laparoscopic gall bladder surgery.', 'detailedDescription': 'Laparoscopic gall bladder surgery is connected with changes in the body resulting in cell damage and inflammation. Melatonin is a hormone produced in brain and regulate sleep rhythm, temperature, production of other hormones and function of organs. Furthermore melatonin can modify cell damage and inflammation. After surgery the production of melatonin is disturbed. The purpose of this study is therefore to determine whether treatment with melatonin can reduce cell damage and inflammation in connection with laparoscopic gall bladder surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indikation for laparoscopic cholecystectomy\n* women between 18 and 70 years old\n\nExclusion Criteria:\n\n* men\n* acute cholecystectomy\n* pancreatitis\n* renal insufficient\n* well-known liver insufficient\n* cardiovascular disease (arrhythmia, well-known ischaemic heart disease)\n* drug therapy (digoxin, Ca-antagonist, amiodaron, beta-blocker)\n* anticoagulation therapy (marevan and marcoumar)\n* praeoperative therapy with opioid, anxiolytica and hypnotica)\n* well-known sleep disease\n* endocrine disease in drug therapy (diabetes mellitus, thyroid disease)\n* daily alcohol consumption (more than 5 drinks)\n* bad compliance (language difficulty, mental problems etc.)\n* pregnancy and breast-feeding\n* lack of written consent'}, 'identificationModule': {'nctId': 'NCT00311259', 'briefTitle': 'Melatonin Treatment and Inflammation, Oxidative Stress and Autonomic Function in Connection With Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'orgStudyIdInfo': {'id': '2612-3108'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Melatonin (drug)', 'type': 'DRUG'}, {'name': 'Laktose', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'contacts': [{'name': 'Bülent Kücükakin', 'role': 'CONTACT', 'email': 'bulkuc01@gentoftehosp.kbhamt.dk', 'phone': '+45 3997824'}], 'facility': 'Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'centralContacts': [{'name': 'Bülent Kücükakin', 'role': 'CONTACT', 'email': 'bulkuc01@gentoftehosp.kbhamt.dk', 'phone': '+45 39978224'}], 'overallOfficials': [{'name': 'Bülent Kücükakin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}}}}